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Chemotherapy After Prostatectomy (CAP) For High Risk Prostate Carcinoma

NCT00132301 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 298

Last updated 2018-06-25

Study results available
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Summary

VA Cooperative Study #553 is designed to prospectively evaluate the efficacy of early adjuvant chemotherapy using docetaxel and prednisone added to the standard of care for patients who are potentially cured by radical prostatectomy but who are at high risk for relapse. The standard of care is surveillance, with the addition of androgen deprivation at the time of biochemical relapse. This study will assess the effect of adding early chemotherapy to the standard of care on progression free survival in Veterans at high risk for progression after prostatectomy.

Conditions

Interventions

DRUG

Docetaxel

Chemotherapy agent

DRUG

Prednisone

steroid in combination with chemotherapy agent

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Daniel Lin · VA Puget Sound Health Care System Seattle Division, Seattle, WA

  • Bruce Montgomery, MD · VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2015-10-31
Completion
2016-09-30

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00132301 on ClinicalTrials.gov