Urology
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Randomized Controlled Trial Clinical Trial
Radiation Therapy Oncology Group P-0014: a phase 3 randomized study of patients with high-risk hormone-naive prostate cancer: androgen blockade with 4 cycles of immediate chemotherapy versus androgen blockade with delayed chemotherapy.
Currently, approximately 30,000 men die annually of metastatic, hormone-refractory prostate cancer. Androgen blockade is palliative and is generally effective for an average of 2 to 3 years until a patient develops androgen-independent disease. Newer chemotherapeutic regimens can induce remissions in approximately 50% of patients; however, median survival for patients with androgen-independent disease is still 8 to 12 months. ⋯ In both of these models, androgen withdrawal was not curative, and the tumors grew back in a hormone-independent state. It is possible that the addition of chemotherapy at the time of initial androgen ablation will improve cell kill by potentiating apoptosis, thereby killing cells that might otherwise have mutated to the androgen-independent state if allowed to continue to cycle and grow. The rationale behind Radiation Therapy Oncology Group (RTOG) P-0014 is to demonstrate in a randomized phase 3 trial that giving patients chemotherapy at the beginning of androgen blockade may improve patient survival.
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Randomized Controlled Trial Clinical Trial
Cancer and Leukemia Group B (CALGB) 90203: a randomized phase 3 study of radical prostatectomy alone versus estramustine and docetaxel before radical prostatectomy for patients with high-risk localized disease.
The purpose of The Cancer and Leukemia Group B (CALGB) 90203 trial is to determine which of 2 treatment strategies is superior in treating men with high-risk, clinically localized adenocarcinoma of the prostate (stage T1 to T3a NX M0), defined as a predicted probability < or =60% of remaining free from disease recurrence for 5 years after surgery. Patients with a > or =10-year life expectancy will be randomized to either radical prostatectomy (RP) alone versus estramustine and docetaxel before RP. Participants will be excluded if they have received prior therapy for prostate cancer (except transurethral resection of the prostate) or are judged not to be appropriate candidates for RP. ⋯ The trial will enroll approximately 700 men during a 48-month period. Patients will be observed for 84 months after study closure. The power to detect a 36% decrease in 5-year recurrence rates is 90%.