Contents
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Next IPCSG Meeting Speaker
February 16, 2019 Member Panel
Last IPCSG Meeting Summary
JANUARY 19, 2019 Radiation Therapy and Prostate Cancer – 2019 Update & Perspectives
Summary
by Bill Lewis
Dr.
Arno J. Mundt, Professor & Chair of the Dept. of Radiation Oncology, and
Sr. Deputy Director, Moores Cancer Center at the University of California San
Diego.
There
is a long history of the use of radiation therapy for prostate cancer, both as
a definitive treatment (without surgery) and as an adjuvant treatment following
surgery. Two main types of radiation are
used: External beam radiation therapy
(EBRT) using photons (X-rays) or protons (particles), normally delivered over
several weeks; and Brachytherapy. The
latter is internal radiation therapy, in which radioactive pellets are
introduced into the prostate, either permanently (low dose rate) or temporarily
(high dose rate). Deciding which
approach to use depends on multiple factors, of which the most important is the
risk group the patient is in. The risk
group may be low, medium or high and depends on the PSA enzyme blood level
(whether <10 moderate="" or="">20), the Gleason score (6, 7, or ≥ 8), and
the “T Stage” (originally based on rectal exam results as to whether nodules
are present, and now also whether the seminal vesicles are involved, or whether
other organs have been invaded). The
intermediate risk group is subdivided into “favorable” and “unfavorable”
groups, mainly depending on how much higher-Gleason-grade disease is present.
Low
risk disease is now usually monitored with “Active Surveillance,” with close
attention to the PSA levels, rectal exams and symptoms. PSA tests are usually performed every three
months, with a repeat biopsy every 1-2 years.
These patients used to be commonly treated with Brachytherapy, but not
often any more. No treatment is given
until test results change significantly, or MRI shows definite growth within
the prostate.
Favorable
intermediate risk disease is not usually given Active Surveillance, but is
treated with surgery or radiation, as discussed below. The “good news” is that ADT (hormone
suppression with Lupron or the like, with many side effects commonly
experienced) is usually not considered to be needed.
Which
treatment is best? Both surgery and
radiation have improved tremendously over the past 30 years. Both have equal cure rates, but toxicity
risks (side effects) are very different.
No one treatment is best. One
treatment may be good for one patient and bad for another. It’s a very personal decision – it’s your
body. Be open-minded and become involved
in the decision. Don’t make snap
decisions based on incomplete information or emotion.
Photons
vs. Protons: Intensity Modulated
Radiation Therapy (IMRT) uses sophisticated computers to “shrink wrap” the
X-ray dose around the prostate, reducing the dose to normal tissue and thus the
risk of toxicity. Protons, unlike
X-rays, stop at a predetermined point in the body, so are even better at
sparing surrounding tissue, and can deliver very focused treatment. UCSD is affiliated with the California Proton
Center. (Refer to our DVD 2018 09 Dr. Rossi available to purchase for more proton
information)
External
beam vs. Brachytherapy: Both are equally
effective. There is a different time
commitment for the patient: EBRT
requires 4-5 weeks (though this is getting shortened). Brachytherapy requires 1-4 treatments,
depending on the dose rate. EBRT has
less bladder toxicity, but can have more rectal bleeding. Brachytherapy may have less sexual
dysfunction.
Unfavorable
intermediate risk disease is usually treated EBRT with or without
Brachytherapy, along with 6 months of ADT.
Clinical trials suggest that adding a Brachytherapy “boost” leads to
better outcomes, and allows a shorter course of EBRT. This is becoming common at UCSD. Surgery is considered less desirable, given
the high likelihood of needing radiation therapy following surgery.
High
risk disease (PSA >20, Gleason 8 or more, and T3 or T4 stage) may be treated
with EBRT (X-ray or protons) + Brachytherapy (as above, increasingly common) +
18 months of ADT. Brachytherapy is not
likely to be used if the patient already has poor urinary function, has had a
prior TURP (reaming out of the urethra), a large prostate, or disease spread
beyond the prostate. Dr. Mundt does not
recommend surgery for high risk patients, because they will almost certainly
need radiation as well, and then would have the negative side effects of both
procedures.
Postoperative
radiation therapy is commonly, but not always, needed following prostatectomy
(i.e., surgery to remove the prostate).
The radiation (either protons or X-rays) can be given soon after surgery,
or can be delayed until the PSA rises.
Prompt administration of radiation is called for in men who have
regained urinary continence (i.e., have healed from the surgery) and who have
positive margins (tumor left behind by the surgery), seminal vesicle invasion,
or disease found outside the prostate.
If the PSA rises from zero after surgery, radiation should be
considered. It is most effective if the
disease is only in the prostate “bed,” which may include margins and seminal
vesicles. Imaging studies can be
critical in determining where the disease is, so that the radiation can be
effectively targeted. Brachytherapy is
not used after surgery. If the PSA is
greater than 0.2, 6 months of ADT is usually added.
Another
traditional use of radiation therapy is in preventing or reducing painful
gynecomastia (breast growth) in men on prolonged ADT. It only requires 3 treatments to each
breast. It’s not routinely used, but may
be requested.
A
new indication for radiation therapy is for oligo-metastatic disease. It is traditionally used in patients with
painful metastases, such as in the bones or spine, and is very helpful to avoid
the need for narcotics. It also can help
prevent fractures, which could require surgery and prolonged bed rest (which is
actually very unhealthy in old patients!).
If
there are only a few metastases, instead of being considered incurable and only
being treated with ADT, now it is considered appropriate to treat such patients
for cure with a combination of ADT and/or chemotherapy plus very focused
radiation therapy. The advent of new
imaging techniques such as C-11 and Axumin has made possible the numbering and
localization of these oligo-metastases.
It often takes only 1 – 5 radiation sessions to “zap” the spot or spots,
which means a very low risk of side effects.
Two
recently-published clinical trials (SABR-COMET trial in Europe/Canada and STOMP
trial in Europe) strongly support the use of SBRT (stereotactic body radiation
therapy, which is super-focused radiation) in patients with oligo-metastatic
disease. In the SABR-COMET trial,
remission time and lifespan after treatment were both doubled. In the STOMP trial, the need for ADT was
delayed almost two years, with no significant side effects. At UCSD, this approach for oligo-metastatic
disease is now standard.
New
Imaging Research – presentation by Tyler Seibert, MD, PhD, of the UCSD faculty.
Standard
imaging (bone, CT) scans miss some tumors and have false positives or ambiguous
results. Newer PET/CT scans such as C-11
or PSMA are much better, but are not widely available, are usually not
reimbursed by insurance, and the PSMA scans are not yet FDA approved.
MRI
may become an attractive option. It is
available at every modern hospital in the U.S.
It is very good at detecting cancer in the prostate, and studies in the
U.S. and Europe have shown promise for metastases too. Scientists at UCSD have
developed an advanced MRI technique called Restriction Spectrum Imaging (RSI)
that is now the clinical standard at UCSD for targeting biopsies, and for
looking for cancer spread outside the prostate.
An
ongoing clinical trial at UCSD is studying the use of whole-body RSI for a) Men
with metastatic prostate cancer and b) Men at high risk of metastases (newly
diagnosed with high- or very-high-risk prostate cancer, newly diagnosed with
disease in lymph nodes, or men with a rising PSA after treatment by radiation
or surgery). There is no cost to the
patient or to his insurance company!
The
imaging takes about an hour, and includes standard MRI and RSI from head to
knees. Results will be compared to other
imaging the patient gets. At least one
such scan needs to be within 3 months of the MRI-RSI scan. The study will also look at treatment
response after radiation, ADT, chemotherapy or other treatment (Keytruda,
Xofigo, etc.).
Whole-body
MRI-RSI could become a widely available way to look at bone metastases. Currently, there is not very good imaging for
evaluating bone lesions for response to therapy. MRI-RSI could be used for precision radiation
therapy (SBRT / Cyberknife), could make it easier for doctors to decide if
their treatment is working or not, and would facilitate clinical trials of new
therapies for metastatic disease. Note
that there is no ionizing radiation with MRI, and no IV contrast is needed.
Questions:
If
the PSA is rising after surgery, how high does it need to be, to qualify for
the whole-body MRI-RSI study? No lower
limit.
Any
hope for patients with a pacemaker to have an MRI scan? Yes, but “down the road.”
Can
patients who are Kaiser Permanente clients join the trial? Yes, since there is no cost to them (or to
the patient), but they do need to approve your going to UCSD.
How
long will the trial last? At least
another 1 – 2 years.
How
does the MRI-RSI compare with PSMA scanning?
Both show similar results. The
study is intended to give a more detailed answer as to “which is better when.”
Can
a PET / CT scan (such as a C-11 acetate scan at the Mayo Clinic) be used for
radiation treatment planning? Yes.
Whole
body MRI scans were offered a year ago at UCSD as part of a research study, but
the results weren’t available to the patient.
Has this changed? Yes, somewhat,
and working through Dr. Mundt or Dr. Seibert would help.
After
Cyberknife treatment for a rising PSA, the PSA has been at zero. What to do?
Be happy, until the PSA rises. It’s not a guarantee that no cancer is
growing, but it’s a very good indication.
Can
prostate cancer affect markers for other cancers? Not likely, especially if the PSA is not
rising. Look for another explanation.
How
do UCSD radiologists and Kaiser interact?
Good working relationship for 9 years already. UCSD can make recommendations, and a Kaiser
group in L.A. decides which treatment to approve. Contact any of the UCSD radiologists for an
appointment, or go through your Kaiser doctor – they all know each other.
The
video of this presentation, including the PowerPoint slides, will be available
via the website shortly before the next meeting, or at that meeting, which will
be held on February 16th, 2019.
Anyone
interested in the RSI trial discussed by Dr. Seibert during our Jan. 19th
meeting may contact:
Katie
O’Neil, Clinical Research Manager
UC
San Diego Health, 1200 Garden View Suite 200, Encinitas, CA 92024-0871
Office:
(760) 479-5376 Fax: (858) 246-0501 croneil@ucsd.edu
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Gene Responsible for Spread of Prostate Cancer Identified
Fri, 01/18/2019 -
4:30pm
by Rutgers
University
A
Rutgers study has found that a specific gene in cancerous prostate tumors
indicates when patients are at high-risk for the cancer to spread, suggesting
that targeting this gene can help patients live longer.
The
study, which was published in the journal Nature Communications, identified the
NSD2 gene through a computer algorithm developed to determine which cancer
genes that spread in a mouse model were most relevant to humans. The researchers
were able to turn off the gene in the mice tumor cells, which significantly
decreased the cancer's spread.
Deeper
Insights
Exploring
DNA Damage/Genotoxicity Using a 7-Plex DNA Damage/Genotoxicity Kit
"Currently,
when a patient is diagnosed with prostate cancer, physicians can determine how
advanced a tumor is but not whether the patients' cancer will spread,"
said lead author Antonina Mitrofanova, an assistant professor at Rutgers School
of Health Professions and a research member of Rutgers Cancer Institute of New
Jersey. "If we can determine whether a patient's cancer is likely to
spread at the time of diagnosis, we can start them on a targeted treatment plan
as soon as possible to decrease the likelihood of their cancer spreading."
Mitrofanova
and collaborators are researching a potential drug to target NSD2, but she
encourages doctors to begin incorporating NSD2 screening so they can start
high-risk patients on anti-metastatic treatment as soon as possible.
While
the algorithm used in the study focused on prostate cancer, Mitrofanova said it
can be applied more broadly to study other cancers to better understand what
findings can be translated to people.
According
to the American Cancer Society, prostate cancer is the second most common
cancer in American men and the second leading cause of cancer deaths.
Cancer Research
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Back to basics: two useful articles to pass along
Posted on December
27, 2018
The
Prostate Cancer Foundation posted two useful and basic articles on its blog
site this December that may be useful resources for men concerned about their
risk for or newly diagnosed with prostate cancer or monitoring their PSA over
time (for any one of all sorts of possible reasons).
The
first, “Make sure your PSA is as accurate as possible” by Janet Farrar
Worthington discusses the importance of understanding that PSA levels can vary
over time for all sorts of possible reasons. It is therefore rarely a good idea
to make critical decisions on the basis of a single PSA test.
Indeed,
Prostate Cancer International and The “New” Prostate Cancer InfoLink advises
men who need to get their PSA levels checked on a regular basis to get all
their tests done (if possible) at the same laboratory, using the same type of
PSA test, and to have blood drawn for those PSA tests at the same time of day
(probably best first thing in the morning on an empty stomach, which is what is
requested when one has blood drawn for things like cholesterol levels too).
The
second, derived from interviews with a whole bunch of prostate cancer survivors
is headed “Prostate cancer survivors: what advice would you give the newly
diagnosed?” by Tim Barley, and is full of good, straightforward guidance and
advice, with the basic messages being “Don’t freak out” and “Do your homework”.
This
correlates well with the core article on this web site entitled, “For newly
diagnosed patients …” with its four-step set of suggestions
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Radical Prostatectomy or Watchful Waiting in Prostate Cancer — 29-Year Follow-up | NEJM:
Original Article
from The New England Journal of Medicine —
Abstract
Background
Radical
prostatectomy reduces mortality among men with clinically detected localized
prostate cancer, but evidence from randomized trials with long-term follow-up
is sparse.
Methods
We
randomly assigned 695 men with localized prostate cancer to watchful waiting or
radical prostatectomy from October 1989 through February 1999 and collected
follow-up data through 2017. Cumulative incidence and relative risks with 95%
confidence intervals for death from any cause, death from prostate cancer, and
metastasis were estimated in intention-to-treat and per-protocol analyses, and
numbers of years of life gained were estimated. We evaluated the prognostic
value of histopathological measures with a Cox proportional-hazards model.
Results
By
December 31, 2017, a total of 261 of the 347 men in the radical-prostatectomy group
and 292 of the 348 men in the watchful-waiting group had died; 71 deaths in the
radical-prostatectomy group and 110 in the watchful-waiting group were due to
prostate cancer (relative risk, 0.55; 95% confidence interval [CI], 0.41 to
0.74; P<0 .001="" 10="" 11.7="" 18.2="" 2.9="" 23="" 2="" 5.2="" 5="" 6="" 7="" 8.4.="" 95="" a="" absolute="" aggressive="" among="" and="" any="" as="" associated="" at="" avert="" cancer="" cause="" ci="" death="" difference="" extension="" extra="" extracapsular="" from="" gained="" gleason="" high="" higher="" in="" indicating="" life="" lower="" mean="" men="" more="" needed="" number="" of="" one="" or="" percentage="" points="" prostate="" prostatectomy.="" prostatectomy="" radical="" range="" risk="" score="" scores="" span="" than="" that="" the="" times="" to="" treat="" underwent="" was="" were="" who="" with="" without="" years="">
Conclusions
Men
with clinically detected, localized prostate cancer and a long life expectancy
benefited from radical prostatectomy, with a mean of 2.9 years of life gained.
A high Gleason score and the presence of extracapsular extension in the radical
prostatectomy specimens were highly predictive of death from prostate cancer.
(Funded by the Swedish Cancer Society and others.)
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News digest – a cancer breath test, tumour VR, lab culture and 2019 predictions
Category: Science
blog January 5, 2019 Gabriella Beer0 comments
A cancer breath
test trial launches
The launch of a
trial we’re supporting for a potential cancer breath test in people was widely
reported. The device uses Breath Biopsy® technology that analyses the presence
and quantity of chemicals in breath. Researchers based at a hospital in Cambridge
hope to find out if the tech can spot signs of cancer in people’s breath to
detect a range of cancers earlier. Read our blog post and press release for the
details.
Cancer
in virtual reality
The BBC visited our
scientists in Cambridge to step inside their immersive 3D models of cancer. The
team is developing a new way to look at tumours using virtual reality.
Advanced liver
cancer patients to receive life-extending treatment on the NHS
The National
Institute for Health and Care excellence (NICE) has said that people with a
type of advanced liver cancer should have access to a targeted cancer drug on
the NHS. Read PharmaTimes for more.
Further calls to
ban nitrates in processed meat
The Evening
Standard reports calls from health experts and politicians for nitrates found
in processed meats, like bacon, to be banned. Meat that has been processed by
adding nitrates, or other ingredients like salt, can increase the risk of
developing bowel cancer.
Mixing
a new lab cocktail
The Atlantic
investigates research showing the liquid used to keep cells alive in the lab,
commonly known as cell culture media, may be skewing results. As a result,
research groups around the world are now mixing their own culture media
cocktails that better mimic conditions inside the body.
Trial to reduce
side effects of prostate cancer surgery launches
The Evening
Standard reports that a new prostate cancer surgery technique is undergoing
trials in hospitals in London. The procedure aims to preserve nerves around the
prostate gland when it’s removed to stop a patient developing erectile
dysfunction, a side effect that can occur after conventional surgery.
And finally
To mark the New
Year, the BBC looked back at the medical discoveries from 2018 that could
impact our lives in the future and reviewed the pressures the NHS is facing in
the year ahead. We also asked some of our experts for their 2019 research ambitions,
which you can read in this post.
Gabi
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www.medscape.com
Finasteride Clears Its Name New Data on Prostate Cancer in NEJM
Nick
Mulcahy
January
23, 2019
Long-standing
concerns about the consequences of finasteride increasing the risk of
high-grade prostate cancer "have not been borne out," report
investigators from the landmark Prostate Cancer Prevention Trial (PCPT).
This
trial previously indicated that finasteride, a 5-alpha-reductase inhibitor
commonly used for benign prostatic hyperplasia and male pattern baldness, is an
effective chemopreventive agent for prostate cancer.
However,
the drug has never been fully accepted for this use, mainly because earlier
results from the trial showed an increased risk of high-grade prostate cancer.
Now,
longer-term results from this trial (median follow-up of 18.6 years) show that
there has been no increase in prostate cancer-related deaths with the drug, the
researchers point out in correspondence published online today in The New
England Journal of Medicine.
Such
an increase would be expected if finasteride truly caused more high-grade
cancers.
"Finasteride
is safe, inexpensive, and effective as a preventive strategy for prostate
cancer," summarized Ian Thompson Jr, MD, principal investigator of the
PCPT and professor emeritus at the University of Texas Health Science Center at
San Antonio.
Thompson
hopes that physicians give finasteride, which is the only proven method for
preventing prostate cancer, a chance in the clinic.
"Doctors
should share these results with men who get regular prostate-specific antigen
tests that screen for the presence of prostate cancer. The drug will have its
greatest effect in this group of men," he said.
New Long-Term Data Show No
Increase in Deaths
The
story of the PCPT starts in the 1990s, when Thompson and co-trialists
randomized more than 18,000 American men ages 55 and older to receive
finasteride (5 mg daily) or placebo for 7 years to prevent prostate cancer.
When
initial results were first published in 2003, the trial was both a success and
a failure.
On the one hand, the risk of
prostate cancer with finasteride was 24.8% lower than with placebo.
But at the same time, there was a
significant increase in the number of high-grade cancers with the drug compared
with placebo (280 vs 237).
This
latter finding torpedoed use of the hormone blocker as a cancer prevention
agent.
"There
is no question that the reason finasteride is not used for prostate cancer
prevention is because of the small but statistically significant increase in
high-grade disease. Absolutely no question," Thompson told Medscape
Medical News at the 2018 annual meeting of the American Urological Association
(AUA), where the newly published data were first presented.
This
finding has been paradoxical, say Thompson and his coauthors in their
correspondence to the NEJM.
So
the team initiated a long-term analysis — to see if the increase in high-grade
disease resulted in more prostate-cancer related deaths in the finasteride
group of the PCPT, as might be expected.
But
that's not how it played out. Instead, in the new analysis, there were fewer
prostate cancer deaths in the finasteride group than in the placebo group (42
vs 56).
This
translated to a 25% lower risk of death from prostate cancer with finasteride
compared to placebo in the trial (hazard ratio 0.75, 95% confidence interval
[CI] 0.50 - 1.12), which was sponsored by the Southwest Oncology Group.
"We
have no evidence that there's an increase in prostate cancer death in the
finasteride arm," Thompson said.
In
other words, the initial study findings in 2003 showing an increase in
high-grade disease are not consequential 16 years later.
Side Effects Not Mentioned
The
newly published letter from the PCPT investigators does not discuss the side
effects of finasteride in men. At the AUA meeting, Thompson indicated that more
sexual adverse effects have been consistently reported with finasteride than
with placebo. However, he described them as "relatively modest."
In
affected men, "it's like being maybe 3 years older," he said. The
trial also showed, among other side effects, that the risk for gynecomastia was
higher with finasteride than with placebo (4.5% vs 2.8%). Notably, the drug has
not been shown to improve overall survival.
The
chemopreventive agent, which is now generic, is inexpensive, about $48 to $108
a month.
At
AUA last year, another urologist endorsed finasteride. "I do use it for
some patients, but they tend to have concomitant urinary symptoms," said
Scott Eggener, MD, from the University of Chicago.
He
said that he discusses finasteride for cancer prevention with some men.
"Most guys, when they hear the data, say, 'that sounds good,' "
Eggener added.
The
sexual adverse effects are concerning, but in his experience and in clinical
trials, only a small percentage of men are affected, and problems such as low
libido and reduced ejaculate are reversible, Eggener told Medscape Medical
News.
The
reputation of finasteride — that it increases the risk for high-grade disease —
is unfair. "I think it's been completely disproven, given the totality of
the research," he said.
The
National Cancer Institute and the National Institutes of Health funded the
study. Thompson and Eggener have disclosed no relevant financial relationships.
N
Engl J Med. Published online January 23,
2019. Full text
Follow
Medscape journalist Nick Mulcahy on Twitter.
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more from Medscape Oncology, join us on Twitter and Facebook
Medscape
Medical News © 2019
Cite
this article: Finasteride Clears Its Name - Medscape - Jan 23, 2019.
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www.medscape.com
Does 'Castrate' in Prostate Cancer Need Revision? Pilot Dataset Questions the Current Standard
Nick
Mulcahy
January
24, 2019
The
level of testosterone (T) in the blood of men with riskier, localized prostate
cancers who undergo hormone therapy should be suppressed to a level lower than
currently accepted to achieve optimal outcomes, suggests a new retrospective
study.
Androgen
deprivation therapy (ADT) is a standard treatment for some men with
intermediate- and high-risk prostate cancer that has not yet spread outside of
the gland, point out the study authors, led by Brent Rose, MD, a radiation
oncologist at the University of California, San Diego.
The
goal of ADT is to reduce T levels to a "castrate" level, which is
historically defined as <50 and="" cancer.="" dl="" hormonal="" ng="" of="" slow="" span="" stimulation="" the="" thereby="">
However,
other research has suggested that, in the setting of metastatic disease,
patients with "nadir" T levels from 20 - 50 ng/dL have poorer
outcomes compared to men who achieve even lower levels of T, namely, <20 be.="" better="" dl.="" in="" level="" lower="" ng="" outcome="" short="" span="" tends="" testosterone="" the="" to="">
So
Rose and colleagues decided to study this issue in men with earlier-stage
disease and add to the small body of related literature.
Their
study was published online December 10, 2018, in the International Journal of
Radiation Oncology - Biology - Physics.
Using
a Veteran's Administration database, the investigators identified 764 men with
intermediate- or high-risk localized prostate cancer who underwent treatment with
ADT and definitive radiotherapy from 2000 to 2015.
The
men were divided into two groups on the basis of their minimum T level during
continuous gonadotropic-releasing hormone agonist therapy: <20 -="" 20="" 49="" and="" dl.="" dl="" ng="" span="">
Rose
and colleagues report that for men with T levels from 20 - 49 ng/dL, 10-year
biochemical recurrence rates were higher (28.1% vs 18.3%), as were metastasis
rates (12.9% vs 7.8%), compared to the patients with T levels <20 dl.="" ng="" span="">
The
difference in rates persisted when the investigator performed multivariable
analyses.
Also,
shorter-term measures favored the group with lower T levels.
Specifically,
the T nadir of 20 - 49 ng/dL was associated with higher 3-month
postradiotherapy prostate-specific antigen (PSA) levels compared to a T nadir
<20 0.12="" 0.16="" 2-year="" and="" dl="" higher="" nadir="" ng="" p=".005).</span" psa="">
Higher
PSA levels are undesirable and are a sign of more active disease.
There
was also a trend toward inferior prostate cancer–specific mortality for the 20
- 49 ng/dL group.
"Our
study suggests that there are clinically significant differences in early PSA
response and long-term clinical outcomes among patients who achieve differing
levels of testosterone suppression below the historical 50 ng/dL castrate
level," summarize the authors.
Inadequate Testosterone
Suppression?
The
new results raise questions about current practice and castrate levels of serum
T, suggested David Wise, MD, PhD, a medical oncologist at New York University
(NYU) Langone Health in New York City.
"The
NCCN [National Comprehensive Cancer Network] guidelines recommend <50 accepted="" an="" and="" dl="" email.="" he="" in="" is="" medical="" medscape="" news="" ng="" span="" standard="" this="" told="">
"This
study provides an intriguing pilot dataset that calls into question the
reliance on this standard <50 added.="" dl="" he="" ng="" span="" threshold="">
The
new findings need further validation in an independent cohort, Wise advised.
The
NYU physician also said that it is standard to check the serum T level after
initiation of androgen suppression to ensure appropriate suppression.
"Inadequate testosterone suppression can happen and is a preventable cause
of poor outcome," he reminded.
Wise
said the new findings are consistent with previous studies that suggest a link
between the depth of testosterone suppression and clinical outcome.
According
to the study authors, the new results also prompt the question, what do you do
clinically when T levels cannot be satisfactorily suppressed?
"Newer
therapies such as abiraterone [multiple brands] and enzalutamide [Xtandi,
Astellas] may suppress serum testosterone more effectively in many patients and
thus hold promise as adjunct therapies in patients with insufficient
testosterone suppression," they propose.
Again,
Wise said use of these agents needed confirmation: "Further prospective
studies will be needed to validate this approach for this highly curable
disease."
The
study was supported by the National Institutes of Health. The authors and Dr
Wise have disclosed no relevant financial relationships.
Int
J Radiat Oncol Biol Phys. Published online December 10, 2018. Abstract
Follow
Medscape journalist Nick Mulcahy on Twitter. For more from Medscape Oncology,
follow us on Twitter.
Medscape
Medical News © 2019
Cite
this article: Does 'Castrate' in Prostate Cancer Need Revision? - Medscape -
Jan 24, 2019.
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https://www.onclive.com/web-exclusives/advancements-emerging-in-nonmetastatic-and-mcrpc-paradigms
Advancements Emerging in Nonmetastatic and mCRPC Paradigms
Caroline
Seymour
Tanya
Dorff, MD
Two
critical clinical trials—SPARTAN and PROSPER—served as the basis for the 2018
FDA approvals of apalutamide (Erleada) and enzalutamide (Xtandi), respectively,
agents that have drastically changed the standard of care for patients with
nonmetastatic castration-resistant prostate cancer (CRPC), said Tanya B. Dorff,
MD.
During
the 2018 OncLive® State of the Science SummitTM on Genitourinary Cancers, Dorff
explained that these approvals have established a foundation for subsequent
progress for patients with nonmetastatic CRPC.
In
the metastatic castration-resistant prostate cancer (mCRPC) space, more
research is moving forward with immunotherapy, PARP inhibitors, and imaging
techniques.
“As
we define molecular subsets, and we find the drugs that have a big impact, such
as PARP inhibitors in patients with DNA repair deficiency, it will likely be
amplified in earlier [lines of therapy]. It’s what we’ve seen with docetaxel in
CHAARTED and abiraterone acetate (Zytiga) and docetaxel in STAMPEDE and
LATITUDE,” said Dorff. “The earlier we use these drugs, the better. The big
space to focus on is trying to bring more durable responses to patients, provided
we don't do it at the cost of quality of life (QoL).”
In
an interview with OncLive® during the meeting, Dorff, associate clinical
professor in the Department of Medical Oncology and Therapeutics Research, and
head of the genitourinary cancers program at City of Hope, discussed landmark
approvals in nonmetastatic CRPC and anticipated developments in metastatic
CRPC.
OncLive®:
What trials have defined the field of nonmetastatic CRPC?
Dorff:
For nonmetastatic CRPC, there were 2 landmark studies that have now changed the
way we practice. First and foremost, it's important to image patients whose
prostate-specific antigen (PSA) is rising despite castration therapy, so that
we can correctly categorize them as metastatic or nonmetastatic––even
oligometastatic versus large-volume metastatic disease. When we do find
patients who are truly nonmetastatic castration-resistant, but we can't find
anything on conventional imaging, we need to check their doubling time to
categorize them as high-risk or not. We use a PSA doubling time cutoff of £10
months. That's what was used in both of the trials.
If
a patient meets all those criteria, we now have treatment options for them,
whereas before we really didn't. We used to do some secondary hormonal
manipulations, but there was nothing we knew would improve survival. Both
apalutamide and enzalutamide were studied in large randomized trials and showed
a positive primary endpoint of metastasis-free survival (MFS). This is a new
endpoint for the prostate cancer community, but it led to the FDA approval of
these drugs in this context. It’s clinically meaningful and resonates with
patients.
We
don’t have comparative data between apalutamide and enzalutamide. Either one is
a perfectly acceptable option. There are some slight differences between their
side effect profiles, but generally speaking there is no major reason to choose
one or the other.
Additionally,
QoL seems to be maintained on these drugs. The other major thing to emphasize
is that fractures were seen on one of the studies. These men have been
castrated for quite a while and are going to continue on castration therapy, so
we have to pay attention to bone supportive therapy when we're treating men in
this earlier-disease setting.
Do
payers have a preference with regard to apalutamide and enzalutamide?
It's
possible that insurers may have a preference. I did have that situation with
one patient. [A payer may opt for one drug] if it is priced more favorably for
their group. Falls or seizures are side effects we traditionally associate with
enzalutamide. If a patient has had issues with falls or seizures, one might
think we should choose apalutamide.
However,
the side effect profile overlaps there. There are no patient characteristics
that stand out, and there shouldn't be a patient preference, I would think. It
would be rare to find a patient who had been exposed to both and could tell you
about both of them. It's going to be up to doctors to get a feel for the drugs
and see how they work relative to each other in this population.
How
important is supplementing treatment with bone-supporting agents?
Bone
health is becoming increasingly important as we hear about studies like ERA-223
with increased fractures. As we move into this earlier disease state, in which
men are going to be on therapy for a lot longer, we can use bisphosphonates,
such as alendronate. We can use 5 mg of zoledronic acid once yearly, or 60 mg
of denosumab (Xgeva) every 6 months. All patients should be instructed to take
calcium and vitamin D. Weight-bearing exercise is also likely important to help
maintain bone strength. It's something that we need to pay attention to.
Looking
to the future, what's coming down the pike?
What
is coming in this space is imaging. A lot of people believe that as we get more
sensitive PET scans, we will no longer categorize patients as having
nonmetastatic CRPC. We know the cancer cells are there, so it's semantics. We
know they're metastatic. It's just a question of whether they're
micrometastatic or macrometastatic on imaging.
As
Gallium-68 prostate-specific membrane antigen (PSMA) and other PSMA agents
become available, this population will shrink. Metastatic hormone-sensitive
will become the new frontier to try new agents in upfront intensification. Of
course, genomic characterization is the other big paradigm shift that should be
brought into the mainstream once we have approval of agents that are designed
for specific molecular subclasses.
You
also spoke on metastatic CRPC. How should clinicians approach sequencing in
that space?
When
we’re sequencing for metastatic CRPC, we have a whole host of options now,
which is great. I remember when I started practicing, I just had standard
castration, a couple of androgen receptor drugs, such as bicalutamide
(Casodex), and chemotherapy. Now, we have all these choices that have been
proven to prolong survival, maintain a good QoL, and reduce skeletal
symptomatic events. It becomes an opportunity to individualize treatment in the
absence of directly comparative data. There is no one right sequence.
You
may have a patient who you might want to give chemotherapy to after they’ve
received abiraterone or enzalutamide. However, they might be elderly, or they
might be young and working and can't afford to quit their job for the 6 months
that you want to give them chemotherapy. We have radium-223 dichloride
(Xofigo), which is a nice option for patients who have bone-only or metastatic
disease that is limited to the bone. For patients with soft tissue and visceral
metastases, that's not an option. On top of chemotherapy, abiraterone, and
enzalutamide, there is immunotherapy with sipuleucel-T (Provenge) for select
patients. Those patients should be minimally symptomatic, asymptomatic, and
have slowly progressing disease.
It's
important to look at the patient's characteristics and think through the pace
of their progression. Moreover, what is the distribution? Imaging becomes key
in this context as well. Sometimes PSA can be going up, even though the patient
looks and feels great. We really want to get the most mileage out of treatment.
If their scans aren’t changing, it’s probably not appropriate to switch
therapy.
What
is the future of PARP inhibitors in this space?
PARP
inhibitors will be the next drugs approved for prostate cancer, and I think it
will happen in 2019. There are phase III trials that have completed showing
that these drugs are effective in BRCA-mutated and certain other DNA-repair
deficiency populations.
We're
going to see comparative studies of olaparib (Lynparza) versus physician's choice
of abiraterone, enzalutamide, or docetaxel. Those studies are going to be
important in benchmarking. It will be the first sort of directly comparative
data we'll have about some of our existing strategies and new strategies. This
will make a huge impact. Unfortunately, it's only 20% or 25% of patients who
have the right mutation. For those patients, it's going to be a very nice
additional tool.
Where
would you like to see researched focused moving forward?
[I
would like to see it focused] in the metastatic hormone-sensitive or perhaps
biochemical recurrence settings. Additionally, a lot of newer studies
incorporate patient-reported outcomes. That’s important. Since this is a
longer-term disease process, we want men to live well as they're living longer.
The
other space that's open for revolution is immunotherapy. It's been
disappointing that the immune checkpoint inhibitors haven't been as successful
in these patients. Sipuleucel-T (Provenge) has been around a while; we know men
live longer when they get it. We're looking for something that will be
game-changing. There are many studies that are combining radiation with
immunotherapy, immunotherapy plus immunotherapy, and exploring which hormone
therapies are most immunogenic. It will take a little bit longer for that to
make its way into clinical treatment, but it's definitely on the horizon within
the next 5 years.
-----------------------------------------------------------------------------------------------------------------------------------------------------------------
Home
» Harvard Health Blog » Hormonal therapy for aggressive prostate cancer: How
long is enough? - Harvard Health Blog
Hormonal therapy for aggressive prostate cancer: How long is enough?
Posted
January 28, 2019, 3:57 pm
Charlie
Schmidt
Editor,
Harvard Medical School Annual Report on Prostate Diseases
Men
weighing treatment options for intermediate- or high-risk cancer that is still
localized to the prostate can face a tricky question. A standard approach in
these cases is to give radiation to the prostate along with drugs that block
testosterone, a hormone that makes the cancer cells grow faster. For how long
should this hormone therapy last? That’s not entirely clear. The drugs have
side effects, such as fatigue, impotence, and a loss of muscle mass. But
radiation doesn’t control prostate cancer effectively without them. Doctors therefore
aim to give hormone therapy only for as long as it takes to help their
patients, without causing any undue harm.
Now,
newly published results from a phase 3 clinical trial are providing some needed
guidance.
How
the study was performed
During
the study, scientists randomized 1,071 men with intermediate- or high-risk
localized prostate cancer into four groups. One group received radiation and
six months of an anti-testosterone drug called leuporelin, and the second group
received radiation plus 18 months of leuporelin therapy. Two other groups were
treated with the same regimens of either radiation plus six or 18 months of
leuporelin therapy, along with another drug called zoledronic acid, which helps
to limit skeletal pain and related complications should cancer spread to the
bones. Study enrollment occurred between 2003 and 2007 at 23 treatment centers
across New Zealand and Australia.
Here’s
what the results showed
After
a median follow-up of just over 10 years, 9.7% of men who were treated with
radiation and leuporelin for 18 months had died from prostate cancer, compared
to 13.3% of the men treated with radiation and leuporelin for six months. Adding
zoledronic acid made no difference in either case.
The
authors concluded that hormonal therapy is more effective at preventing
prostate cancer death when it’s given for 18 months rather than six. And
similar benefits were noted for other endpoints as well. For instance, prostate
tumors were less likely to metastasize, or spread, among men in the longer
duration treatment group, and it took longer for their cancers to become
resistant to hormone therapy if it was reinitiated later.
In
earlier clinical research, scientists discovered that hormonal therapy given
for three years protects against prostate cancer death more effectively than a
six-month treatment regimen. But three years of hormone therapy isn’t easily
tolerated, and evidence so far shows that 10-year survival rates after either
18 months or three years of hormonal therapy are similar, the authors of the
new study claim.
“This
study reaffirms what many clinicians have put into practice: longer duration
hormonal therapy in appropriately selected patient populations provides a
greater benefit,” said Dr. Marc Garnick, the Gorman Brothers Professor of
Medicine at Harvard Medical School and Beth Israel Deaconess Medical Center,
and editor in chief of HarvardProstateKnowledge.org. “Prior studies using three
years of hormonal therapy have also shown this, but it is important to
recognize that some men may have significantly delayed return of the body’s
testosterone upon completion of the therapy — a fact that needs to be discussed
when contemplating longer-term treatment programs.”
-----------------------------------------------------------------------------------------------------------------------------------------------------------------
MRI grading system helps simplify prostate cancer assessment
January
25, 2019 | Matt O'Connor | Diagnostic Imaging
A
team of national researchers has identified a set of multiparametric MRI-based
guidelines and clinical features which can help clinicians easier determine a
patient’s risk their prostate cancer will spread, according to a Jan. 22 study
published in Radiology.
Extraprostatic
extension (EPE) occurs when a tumor extends beyond glands in the prostate and
is associated with an increased risk of biochemical recurrence, metastatic
disease and lower cancer-specific survival after prostatectomy, wrote first
author, Sherif Mehralivand, with University Medical Center in Mainz, Germany,
and colleagues.
This
new grading system, however, may allow for earlier detection and better
treatment for these patients.
“The
system adds additional diagnostic value to clinical parameters and provides a
graded quantifiable risk assessment of pathologic EPE,” the authors wrote. “It
is based on only a few imaging features, making it easy to teach, and it should
be relatively easy to implement.”
The
team retrospectively analyzed 553 men (mean age of 60) who underwent 3T MRI
followed by robotic-assisted laparoscopic radical prostatectomy—125 men had
pathologically-confirmed EPE.
They
determined EPE visible with MRI, curvilinear contact length greater than 1.5 cm
and capsular bulge and irregularity were all the main features associated with
a higher risk of EPE. These markers made up their four-point grading system.
Grade 0 is no suspicion of pathologic EPE; grade 1 included curvilinear contact
length or capsular bulge and irregularity, grade 2 included both features and
grade 3 meant MRI-verified EPE or tumor expansion past the prostate.
As
the grades went up, so did the detection of pathologic EPE. For grades 1,2 and
3 those rates were 24 percent, 38 percent and 66 percent, respectively.
Additionally,
combining clinical features with the MRI-based EPE grading system predicted EPE
better than MRI alone (AUC of 0.81 compared to 0.77).
-----------------------------------------------------------------------------------------------------------------------------------------------------------------
Links to Further Reading:
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& SCIENCE - Jerusalem Post: “We believe we will offer in a year's time
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Improves Survival in Metastatic Castration-Sensitive Prostate Cancer:
Apalutamide (Erleada) in combination with androgen deprivation therapy was
found to significantly improve radiographic progression-free survival and
overall survival versus placebo in patients with metastatic
castration-sensitive prostate cancer.
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European Urology Focus: Following a healthy lifestyle practice is
recommended for all patients with cancer diagnosis. However, results from the MARTINI-Lifestyle
cohort suggest poor adherence to the World Cancer Research Fund/American
Institute for Cancer Research (WCRF/AICR) recommendations among patients with
prostate cancer. Thus, encouraging patients to improve lifestyle seems to be
justified.
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Economic
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Foundation to see if you qualify for economic support for your prostate cancer
drugs.
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Using
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Post-Operative Prostate Cancer: IEEE Computer Society Digital Library
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will empower men concerned with prostate cancer. ASPs goal is to provide the
most current information to help these patients make informed decisions
regarding approaches to AS and choosing appropriate care.
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Hormonal
therapy for aggressive prostate cancer: How long is enough? - Harvard Health
Blog - Harvard Health Publishing: Men weighing treatment options for
intermediate- or high-risk cancer that is still localized to the prostate can
face a tricky question. A standard approach in these cases is to give radiation
to the prostate along with drugs that block testosterone, a hormone that makes
the cancer cells grow faster. For how long should this hormone …
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guidelines and clinical features which can help clinicians easier determine a
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dominant debilitating symptom. This is an international, multi-center single
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and a dominant debilitating symptom. The dominant symptomatic lesion will
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an apparent diffusion coefficient (ADC) map will be calculated for the lesion
using diffusion weighted imaging sequences. The dominant symptomatic lesion
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tomography scans. The most aggressive part of the dominant lesion (GTV2) is
defined by using the ADC map. An auxiliary volume is created including only
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aggressive part is defined as voxels with an ADC value below the median ADC
value. Primary endpoint is feasibility, i.e. proportion of pat
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