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Targeting Occult Cancer Cells in High-risk Prostate Cancer Patients
Untitled Document
Name of the Trial
Phase III Randomized Study of Radical Prostatectomy With Versus Without Neoadjuvant
Chemohormonal Therapy Comprising Docetaxel and Androgen-Deprivation Therapy
With Leuprolide Acetate or Goserelin in Patients With High-Risk, Clinically
Localized Prostate Cancer (CALGB-90203). See the protocol
summary.
Principal Investigators
Dr. James Eastham, Cancer and Leukemia Group B; Dr. Martin Sanda, Eastern Cooperative
Oncology Group; Dr. Martin Gleave, NCIC-Clinical Trials Group.
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Dr. James Eastham
Principal Investigator |
Why This Trial Is Important
Prostate cancer is classified as localized when there is no evidence it has
spread (metastasized) to nearby tissue or lymph nodes. However, patients treated
with surgery to remove the prostate and some surrounding tissue (radical prostatectomy)
often experience recurrence of their disease due to the presence of undetectable
(occult) cancer cells.
Doctors want to improve their ability to identify prostate cancer patients
who fall into this high-risk group, i.e., men who have less than a 60 percent
chance of remaining recurrence-free 5 years after treatment. One way to identify
these patients takes into account factors such as tumor stage, higher levels
of prostate-specific antigen (PSA), and other clinical signs (for example, a
higher Gleason score). However, said Dr. Eastham, "Once we identify them,
there is no accepted treatment strategy for high-risk patients."
Some high-risk patients elect treatment before surgery (neoadjuvant therapy)
in hopes of improving their long-term outcome. If their cancer's growth is dependent
upon male hormones (androgens), anti-androgen therapy before surgery can reduce
the extent of their disease. If their cancer is androgen-independent, systemic chemotherapy with a taxane drug has been shown to improve long-term survival.
In this trial, patients classified as high risk will be randomly assigned to
undergo a course of neoadjuvant therapy or proceed directly to surgery. The
neoadjuvant therapy will involve up to 18 weeks of docetaxel chemotherapy combined
with hormone-depriving therapy using one of two drugs, either goserelin or leuprolide
acetate, for 18-24 weeks. The idea, said Dr. Eastham, is to target two different
populations of cancer cells that might separately be sensitive to each of these
different approaches. "If such a strategy were effective, it could significantly
change clinical practice."
For More Information
See the list of eligibility
criteria and contact information or call the NCI's Cancer Information Service
at 1-800-4-CANCER (1-800-422-6237). The call is toll free and confidential.
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