Chemotherapy After Prostatectomy (CAP) For High Risk Prostate Carcinoma

Completed · Phase 3

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00132301

Run by

VA Office of Research and Development

People needed

298

Starts

2006-06-01

Expected to finish

2016-09-01

Last updated by the study team

2018-06-25

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• VA Medical Center, Birmingham — Birmingham, Alabama, United States
• Southern Arizona VA Health Care System, Tucson — Tucson, Arizona, United States
• Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock — North Little Rock, Arkansas, United States
• VA Medical Center, Long Beach — Long Beach, California, United States
• VA San Diego Healthcare System, San Diego — San Diego, California, United States
• VA Medical Center, San Francisco — San Francisco, California, United States
• VA Greater Los Angeles Healthcare System, West LA — West Los Angeles, California, United States
• VA Connecticut Health Care System (West Haven) — West Haven, Connecticut, United States
• North Florida/South Georgia Veterans Health System — Gainesville, Florida, United States
• VA Medical Center, Miami — Miami, Florida, United States
• James A. Haley Veterans Hospital, Tampa — Tampa, Florida, United States
• VA Medical Center, Augusta — Augusta, Georgia, United States
• Jesse Brown VAMC (WestSide Division) — Chicago, Illinois, United States
• VA Medical Center, Lexington — Lexington, Kentucky, United States
• Overton Brooks VA Medical Center, Shreveport — Shreveport, Louisiana, United States
• VA Ann Arbor Healthcare System — Ann Arbor, Michigan, United States
• John D. Dingell VA Medical Center, Detroit — Detroit, Michigan, United States
• VA Medical Center, Minneapolis — Minneapolis, Minnesota, United States
• G.V. (Sonny) Montgomery VA Medical Center, Jackson — Jackson, Mississippi, United States
• VA Medical Center, Kansas City MO — Kansas City, Missouri, United States
• New Mexico VA Health Care System, Albuquerque — Albuquerque, New Mexico, United States
• VA Western New York Healthcare System at Buffalo — Buffalo, New York, United States
• VA Medical Center, Durham — Durham, North Carolina, United States
• VA Medical Center, Portland — Portland, Oregon, United States
• VA Pittsburgh Health Care System — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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