Phase 3 N=731 Randomized Treatment

Prostate Cancer Intervention Versus Observation Trial (PIVOT)

Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00007644 ↗

Enrolled (actual)

731

Serious AEs

48.4%

Results posted

Jan 2014

Primary outcome: Primary: All Cause Mortality — 171; 183 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Radical prostatectomy (Procedure)
Age: Pediatric, Adult, Older Adult
Sex: Male
Sponsor: VA Office of Research and Development
Primary completion: Jan 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY All Cause Mortality	171; 183	—

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.

Eligibility Criteria

Inclusion Criteria

Patients with clinically localized CAP
Diagnosis of Prostate Cancer within previous 6 months
Age 75 years or younger

Exclusion Criteria

PSA > 50 ng/ml Bone scan consistent with metastatic disease Other evidence that cancer of the prostate is not clinically localized Diagnosis of prostate cancer greater than 12 months ago Life expectancy less than 10 years Serum creatinine greater than 3 mg/dl Myocardial infarction within last 6 months Unstable angina New York Heart Association Class III or IV congestive heart failure Severe pulmonary disease Lifer failure Severe dementia Debilitating illness Malignancies, except for nonmelanomatous skin cancer, in the last 5 years

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00007644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.