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A Phase III Study of Androgen Deprivation with Leuprolide with or without Docetaxel for Clinically Asymptomatic Prostate Cancer Patients with a Rising PSA Following Surgery
[Protocol 07-101]
- Full Title :
- A RANDOMIZED, OPEN LABEL, MULTICENTER, PHASE III, 2-ARM STUDY OF ANDROGEN DEPRIVATION WITH LEUPROLIDE +/- DOCETAXEL FOR CLINICALLY ASYMPTOMATIC PROSTATE CANCER SUBJECTS WITH A RISING PSA FOLLOWING DEFINITIVE LOCAL THERAPY
- Purpose :
Men who have their prostate removed (prostatectomy) as a treatment for prostate cancer but whose prostate-specific antigen (PSA) level rises at a rapid rate despite surgery have an increased risk of developing metastatic disease (cancer which spreads to other parts of the body). Hormonal therapy to reduce testosterone levels is a standard treatment for patients with metastatic prostate cancer. It is not known whether hormonal therapy is the best treatment for treating patients who have a rising PSA but no evidence of metastasis.
Docetaxel is a type of chemotherapy that is also standard treatment for patients with metastatic prostate cancer. Docetaxel is usually used to treat patients whose cancers have grown in spite of hormonal therapy. Doctors do not know if adding docetaxel to hormonal therapy is better than hormonal therapy alone for patients who have a rising PSA after a prostatectomy.
In this study, researchers will evaluate the effectiveness of hormonal therapy, with and without docetaxel, in men with a rising PSA after prostatectomy but no evidence of metastatic disease. Patients will be randomly assigned to one of two groups: hormonal therapy alone (the drugs leuprolide and bicalutamide) or hormonal therapy plus docetaxel.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of prostate cancer that has been surgically removed.
- Patients must have a minimum PSA of 1 ng/ml that is rising at a rate such that the PSA doubles every nine months (or faster) and a serum testosterone level of 100 ng/dl or more.
- Patients may not have had prior chemotherapy, immunotherapy, radiation therapy, or cryotherapy. Patients may have had up to 6 months of prior hormonal therapy.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Michael Morris at 646-422-4469.
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