At a glance
ClinicalIndex Comparison Record- ✓Clinically localized prostate cancer
- ✓Diagnosis within previous 6 months
- ✓Age 75 years or younger
- ✕PSA greater than 50 ng/ml
- ✕Evidence of metastatic disease on bone scan
- ✕Cancer not clinically localized
- ✕Diagnosis more than 12 months ago
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
CSP #407 - Prostate Cancer Intervention Versus Observation Trial (PIVOT): A Randomized Trial Comparing Radical Prostatectomy Versus Palliative Expectant Management for the Treatment of Clinically Localized Prostate Cancer
In Brief
A Phase 3 clinical trial evaluating Radical prostatectomy for Prostate Cancer. Completed, enrolled 731 participants across 31 sites.
Detailed Summary
Radical prostatectomy provides potentially curative removal of the cancer. However, it subjects patients to the morbidity and mortality of the surgery and may be neither necessary nor effective. Expectant management does not offer potential cure. However, it provides palliative therapy for symptomatic or metastatic disease progression, avoids potentially excessive and morbid interventions in asymptomatic patients, and emphasizes management approaches for focus on relieving symptoms while minimizing therapeutic complications. The primary objective of this study is to determine which of two strategies is superior for the management of clinically localized CAP: 1) radical prostatectomy with early aggressive intervention for disease persistence or recurrence, 2) expectant management with reservation of therapy for palliative treatment of symptomatic or metastatic disease progression. Outcomes include total mortality, CAP mortality, disease free and progression free survival, morbidity, quality of life, and cost effectiveness.
Study Details
Timeline
Interventions
Surgical removal of the prostate