Chemotherapy After Prostatectomy (CAP) For High Risk Prostate Carcinoma

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Collaborator: Sanofi
• Treatments: Docetaxel; Prednisone

Criteria

Inclusion Criteria:

• A histologic diagnosis of cT1-T2 primary adenocarcinoma of the prostate prior to prostatectomy, with lymph node dissection at time of radical prostatectomy

• One or more of the following poor prognostic features:

• tumor extension to seminal vesicle (pT3b) or bladder neck (T4)

• established extracapsular extension (pT3a) and Gleason Score >= 7

• organ confined (pT2) with positive surgical margin and Gleason 8-10

• preoperative PSA > 20

• SWOG performance status 0-1

• PSA nadir of <= 0.1 ng/ml up to 30 days prior to randomization. Patients must be randomized within 120 days after prostatectomy.

• Laboratory values (no more than 30 days before randomization) must be as follows:

• Absolute granulocyte count: >= 1,500/mm3

• Platelets: >= 100,000/mm3

• Hemoglobin: >= 10 g/dL

• Serum Creatinine: <= 1.5 x ULN

• AST: <= 1.5 x ULN

• ALT: <= 1.5 x ULN

• Serum Calcium: <= ULN

• Total Bilirubin: <=ULN

• Plasma Phosphorus Level: <= 6 mg/dl

• Patients with preoperative PSA > 20 ng/mL must have a negative bone scan within 120 days of randomization

• A valid, signed, and witnessed informed consent by the patient

Exclusion Criteria:

• Small cell histology

• N1 disease or M1 disease

• Clinical T3 disease prior to prostatectomy

• Any other investigational therapy

• An active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment

• A history of cancer related hypercalcemia

• Uncontrolled heart failure

• Prior malignancy other than curatively treated squamous cell or basal cell carcinoma of the skin. If another malignancy has been treated and there is no evidence of relapse > 5 years from the time of treatment, patients are eligible

• Androgen deprivation, chemotherapy, or radiation therapy to treat prostate carcinoma

• Current peripheral neuropathy of any etiology that is greater than Grade I