Chemotherapy After Prostatectomy (CAP) For High Risk Prostate Carcinoma
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Docetaxel; Prednisone
Intervention description: Chemotherapy agent; steroid in combination with chemotherapy agent
Intervention MeSH terms: Prednisone; Docetaxel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking description: The Endpoint Committee will adjudicate evidence for progression, metastasis, and cause of death. The committee will be blinded to the treatment assignment.
Enrollment: 298.0
Sex: Male
Healthy volunteers: No
Keywords: multi-site clinical trial; prostate; radical prostatectomy; randomized

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.
    

Eligibility 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