Status:
COMPLETED
Chemotherapy After Prostatectomy (CAP) For High Risk Prostate Carcinoma
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Sanofi
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE3
Brief 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 potentiall...
Detailed Description
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 potentiall...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
298 Patients enrolled
Trial Details
Trial ID
NCT00132301
Start Date
June 1 2006
End Date
September 1 2016
Last Update
June 25 2018
Active Locations (34)
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1
VA Medical Center, Birmingham
Birmingham, Alabama, United States, 35233
2
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, United States, 85723
3
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
North Little Rock, Arkansas, United States, 72114-1706
4
VA Medical Center, Long Beach
Long Beach, California, United States, 90822