Phase 3
N=298
Chemotherapy After Prostatectomy (CAP) For High Risk Prostate Carcinoma
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00132301 ↗Enrolled (actual)
298
Serious AEs
32.7%
Results posted
Jun 2018
Primary outcome: Primary: Number of Participants With Progression-Free Survival — 66; 84 Participants — p=0.40
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Docetaxel (Drug); Prednisone (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Male
- Sponsor
- VA Office of Research and Development
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Progression-Free Survival |
66; 84 | 0.40 |
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 = 1,500/mm3
- Platelets: >= 100,000/mm3
- Hemoglobin: >= 10 g/dL
- Serum Creatinine: 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
Data sourced from ClinicalTrials.gov (NCT00132301). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.