New Type Of Hormone Therapy Extends Prostate Cancer Patients

Lives, Study Finds

Posted on May 27, 2012

The drug abiraterone acetate gave men with advanced prostate cancer an average of four
months of extra life, according to Phase III trial results published in the New England Journal of
Medicine today. Abiraterone acetate, trade name Zytiga, was discovered at The Institute of Cancer
Research (ICR) in what is now the Cancer Research UK Cancer Therapeutics Unit. It was first trialled
at The Royal Marsden Hospital.
The success of an anti-hormone therapy in men with late stage prostate cancer challenges
conventional wisdom, opening the door to an entirely new way of treating these patients. Men with
advanced prostate cancer have very few therapies available to them* and sadly around 10,000
patients in the UK die each year from this disease, says Chief Investigator and lead author Professor
Johann de Bono from the ICR and The Royal Marsden. We are thrilled that a drug discovered at The
Institute of Cancer Research has been proven to significantly extend life for many men, giving doctors
a valuable new treatment option.
The positive study results led the US Food and Drug Administration (FDA) on April 28 to
approve abiraterone acetate as a pill in combination with the steroid prednisone for men with latestage castration-resistant** prostate cancer who have received prior docetaxel chemotherapy. The
drugs manufacturer Janssen Pharmaceutical Companies has also applied for regulatory agency
approvals in Europe, but for now the drug is not available to patients in the UK. Prostate cancer
growth is fuelled by the male hormone testosterone. Hormone treatments that block the testes
production of testosterone usually stop benefiting patients after a few years, leading to the
assumption that as tumours progressed they developed the ability to grow independently of
testosterone.
However it was known that the adrenal glands also produce testosterone, suggesting that this
was providing fuel to some cancer cells. In addition, scientists elsewhere had measured higher levels
of enzymes involved in testosterone synthesis inside prostate tumour tissue, giving rise to a new
theory that some cancers were able to produce their own testosterone.
Professor Mike Jarman and his team in what is now the Cancer Research UK Cancer
Therapeutics Unit at the ICR in Sutton, south of London, designed abiraterone acetate to have a
different mechanism of action from standard hormone treatments blocking the production of male
hormones in all tissues, not just the testes, by targeting an enzyme involved in hormone synthesis
called CYP17. From the success of this study, its now clear that men with advanced prostate cancer
can still benefit from treatments targeting male hormones. This has corrected 40 years of
misunderstanding about this disease and we hope it will lead to the development of more second-line
hormone treatments for these men much like those used successfully to treat breast cancer, ICR
Chief Executive Professor Alan Ashworth says.
The randomised, double-blind study sponsored by Ortho Biotech Oncology Research &
Development, a Unit of Cougar Biotechnology, Inc., began in May 2008 and was conducted in 147
sites in 13 countries. The 1,195 men who enrolled in the trial had all stopped responding to standard
hormone therapy as well as second-line treatments including the chemotherapy drug docetaxel. They
were either given abiraterone acetate together with the steroid prednisone (797 men), or prednisone
and a placebo (398 men).
The study was designed to assess overall survival (the primary endpoint) and showed that
men given the placebo survived an average of 11 months, while men given abiraterone acetate
survived for nearly 15 months. Pain eased during the trial for a much greater number of patients
taking abiraterone acetate than the placebo (44 per cent versus 27 per cent in patients for whom this
could be measured). Based on results of a prespecified interim analysis of the study, the trials
Independent Data Monitoring Committee recommended unblinding the trial and allowing anyone on
the placebo arm to be offered the drug.

The scientists also examined other possible measures of a drugs effectiveness (as secondary
endpoints). When compared to the placebo group, patients taking abiraterone acetate were also
more likely to experience a significant drop in their prostate specific antigen (PSA) levels, the
standard measure of prostate cancer activity (29 per cent versus six per cent), and they had more
time before their PSA level started to rise again (10.2 months versus 6.6 months). X-rays showed
mean time until tumour growth among the treatment group was also longer (5.6 months versus 3.6
months).
Doctors reported that patients taking abiraterone acetate generally did not experience some of
the unpleasant side-effects they often observe in men being treated with chemotherapy. In this trial,
patients in the abiraterone acetate group compared to the placebo group did report more side-effects
such as fluid retention and swelling related to elevated levels of the mineralocorticoid class of steroid
hormones, but these could usually be managed.
Harpal Kumar, Cancer Research UKs chief executive, said: Abiraterone is the first treatment
of its kind shown to be effective in men with this type of advanced prostate cancer. This could make a
huge difference to the 10,000 men diagnosed with aggressive forms of the disease in the UK every
year. Thanks to our supporters, Cancer Research UK was a major funder of the discovery and early
development of abiraterone including the first studies in humans. Its incredibly heartening to see this
early potential being turned into a treatment capable of providing patients with valuable extra months
of life. Abiraterone acetate is not currently available in the UK.

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In men with advanced prostate cancer, only three other drugs have been shown to prolong survival
chemotherapy drugs docetaxel and cabazitaxel and the immunotherapy drug Sipuleucel. Prostate
cancer depends on the hormone testosterone in order to grow. Testosterone is produced by the
testicles and a small amount is also produced by the adrenal glands. Hormonal therapies work by
reducing the amount or activity of testosterone in the body. There are different types of hormonal
therapies that can be used to treat advanced prostate cancer. You may be offered treatment with
more than one type. If youve had hormone treatment before, you may be advised to try a different
type.
Hormonal treatment works well for most men with advanced prostate cancer, and the cancer can
often be controlled for some time. Your doctor will check how well the cancer is responding to
treatment by checking your symptoms and examining you. Your PSA level will also be measured, as
this is usually a good guide to how effective treatment is. If the cancer starts to grow again, your
doctor may suggest you change to a different hormonal therapy drug.
Although there are several drugs that can be used, at some point the cancer will stop responding to
hormonal therapy. This is known as hormone-refractory prostate cancer or castration-refractory
prostate cancer. If hormonal therapy is no longer working, your doctor may suggest chemotherapy or
other treatments to relieve symptoms (palliative treatments). You should know what drugs or care works
better to you and always consult your doctor for further information. It is good that everyday, scientist
found a new treatment for a different diseases and hopefully, they can find a cure for cancer
someday.

New Combined-Tool Imaging May Spot Hard To Detect Ovarian Cancer

Written by Catharine Paddock PhD

13 Sep 2012

Using only minimally invasive surgery, a device that combines three previously unrelated imaging
tools may help diagnose hard to detect early-stage ovarian cancer in high-risk women, thanks to the
efforts of researchers from the University of Connecticut and the University of Southern California in
the US. The researchers, who propose the new approach may be better than the current standard
method of preemptively removing the ovaries, write about how they tested their device in the
September issue of Biomedical Optics Express, the Optical Society of America's (OSA) open-access
journal.
The survival rates for ovarian cancer are low because the disease is hard to detect, hence its
reputation as the "silent killer". The authors write that the disease "is predominantly diagnosed in
Stages III or IV due to the lack of reliable symptoms, as well as the lack of efficacious screening
techniques".
Now, by combining multiple imaging tools, the researchers think they have come up with a new way
of spotting much earlier the changes in ovarian tissue that indicate cancer.
The new device, which they describe as a "prototype endoscopy system for ovarian tissue
characterization", brings together three imaging technologies: photoacoustic imaging (PAI), optical
coherence tomography (OCT) and pulse-echo ultrasound (US). The first provides contrast, the
second offers high-resolution sub-surface imaging and the third provides deep-tissue imaging.
In their paper, the researchers describe the prototype device as comprising:
" ... a ball-lensed OCT sample arm probe, a multimode fiber having the output end polished at 45
degree angle so as to deliver the light perpendicularly for PAI, and a high frequency ultrasound
transducer with 35MHz center frequency."
They go on to detail how they tested the prototype device on both pig and human ovarian tissue. It
correctly identified malignant tumors that were later confirmed by tissue staining and examination
under a microscope.
They conclude that:
"The optical absorption contrast provided by PAI, the high resolution subsurface morphology provided
by OCT, and the deeper tissue structure imaged by US demonstrate the synergy of the combined
endoscopy and the superior performance of this hybrid device over each modality alone in ovarian
tissue characterization."
Although these tests were done on tissue that had already been removed, because the device has a
diameter of only 5 mm, the researchers suggest it could be inserted through a small laparoscopic
incision during minimally invasive surgery to image tissue in live patients.

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Ovarian cancer is cancer that begins in the ovaries, the egg-producing female reproductive organs.
The cause of ovarian cancer, the fifth most common cancer among women, is unknown. The National
Cancer Institute estimates that in 2010, 21,880 women in the United States will be diagnosed with
ovarian cancer and 13,850 women will die from the disease.
Ovarian cancer is highly curable when treated at an early stage. However, because there is no
effective screening test for the disease and its symptoms are often vague, the majority of women are
diagnosed at a late stage when survival rates are very low.
The imaging device detects the imaging agent and creates pictures that show how the imaging agent
it is distributed in the body; this distribution pattern helps physicians discern how well organs and
tissues are functioning. Using these new technologies and the information they provide, physicians
are able to evaluate how well organs and tissues are working and to detect abnormalities.
Early detection and accurate diagnosis are essential to increasing ovarian cancer survival rates.
Researchers also believe prototype imaging imaging holds promise for detecting ovarian cancer
before it spreads into other areas of the body.