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%.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Levofloxacin for chronic prostatitis/chronic pelvic pain syndrome in men: a randomized placebo-controlled multicenter trial.
To perform a Canadian multicenter randomized placebo-controlled trial to evaluate the safety and efficacy of 6 weeks of levofloxacin therapy compared with placebo in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Uncontrolled studies have supported the use of antibiotics in CP/CPPS. ⋯ This pilot placebo-controlled study showed that 6 weeks of levofloxacin therapy in men diagnosed with CP/CPPS resulted in symptom improvement that was not significantly different from that with placebo at end of treatment or follow-up. The clinical ramifications of these findings need to be addressed.
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Randomized Controlled Trial Clinical Trial Controlled Clinical Trial
Alfuzosin treatment for chronic prostatitis/chronic pelvic pain syndrome: a prospective, randomized, double-blind, placebo-controlled, pilot study.
To perform a prospective, placebo-controlled study to examine the long-term efficacy of alfuzosin compared with placebo and standard therapy in patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), because alpha-blockers have been suggested for the treatment of CP/CPPS. ⋯ Six months of alfuzosin therapy for CP/CPPS is safe and well tolerated and results in a modest, but statistically significant, improvement in the NIH-CPSI, particularly in the pain domain, compared with placebo and standard/traditional treatment. The beneficial effect is only apparent after several months of treatment and disappears when treatment is discontinued.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Long-term 6-year experience with finasteride in patients with benign prostatic hyperplasia.
To summarize the 6-year clinical trial data with finasteride. Benign prostatic hyperplasia is a chronic and progressive disease and therefore assessment of long-term safety and efficacy is important. ⋯ Treatment with finasteride leads to durable improvement in urinary tract symptoms, flow rate, and prostate volume, with no increase in the prevalence of drug-related adverse events over time.