Posted on the Prostate Problems Mailing list about two months ago was a notice from Dr. Richard Lam about a clinical trial in which his office, Prostate Oncology Specialists, will participate.

What I found particularly interesting in this trial is that it was evaluating a potential new drug, abiraterone acetate, which could be used after the failure of Taxotere. Currently, we have only one approved chemotherapy drug to treat advanced prostate cancer. Once we become Taxotere-refractory all that is available to us is palliative care.

I also thought that this trial was timely in light of yesterday’s post (June 3, 2008), “Maybe A Misnomer – Prostate Cancer Resistance to Androgen Deprivation Therapy.” In this prior post, I spoke of research that poses one of the theories as to how prostate cancer becomes androgen independent. The underlying theory is, that distant tumors at the cellular level, manufacture their own androgens that are able to feed the cancer. My take home message was that we need to develop new, supplementary treatment strategies that target the distant tumors at their cellular level.

Dr. Lam’s announcement about the clinical trial of abiraterone acetate seems to fit directly into this category. Clinical trials are our best shot at improving our lot and expanding our options. We are in desperate need of more and better treatments for prostate cancer. The following is Dr. Lam’s recruiting announcement. If you missed it on the board, here is an opportunity get involved to gain access to cutting edge treatments and contribute to the progress of our fight against prostate cancer.

“I would like to inform you of a new multicenter, multinational study that
Prostate Oncology Specialists will be participating in. This phase III
trial, COU-AA-301, involves a new agent named abiraterone; this novel
adrenal androgen inhibitor has exhibited excellent PSA response rates
(greater than 50%) in phase II studies involving androgen-independent
chemo-naïve and Taxotere-refractory patients. What makes abiraterone unique
is its added ability to deplete androgens intracellularly in malignant

As you are aware, two large studies have demonstrated that Taxotere improves
overall survival for men with hormone refractory prostate cancer. However,
once patients progress on Taxotere, there are no FDA-approved therapies.
The goal of COU-AA-301 (this trial) is to demonstrate a clinical benefit of abiraterone
for this clinical scenario.

Study Design
Randomization allocation ratio of 2:1 between abiraterone plus prednisone
and placebo plus prednisone.

Inclusion Criteria
1. Ongoing androgen deprivation with a testosterone level<50. 2. Evidence of radiographic or PSA progression. 3. Exposure to at least 1, not more than 2, chemotherapy regimens; 1 regimen must include Taxotere. 4. Serum creatinine less than 1.5x ULN. 5. Serum albumin>3.0.
6. Hemoglobin>9.0.
7. ECOG performance status of 2 or less.
8. Histologically confirmed adenocarcinoma without neuroendocrine or
small cell features.

Exclusion Criteria
1. Abnormal kidney or liver function.
2. Serious non-malignant disease, including uncontrolled congestive
heart failure, hypertension, infection, hepatitis, severe gastrointestinal
disorders, or adrenal dysfunction.
3. Prior ketoconazole exposure.
4. Radiation, chemotherapy, or surgery within 30 days of the first

If you have any questions, please call me anytime at 310-827-7707.


Richard Lam, MD”

The abiraterone acetate trial is being sponsored by Cougar Biotechnology Inc. (NASDAQ CGRB).

Additional information about the trial can be seen at the National Cancer Institutes (NVI) clinical trials web page located at :

Joel T Nowak MA, MSW