Clinical trial · Interventional
Chemotherapy After Prostatectomy (CAP) For High Risk Prostate Carcinoma
CSP #553 - Adjuvant Therapy in Prostate Carcinoma Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1: Docetaxel and Prednisone
- description
- Chemotherapy after radical prostatectomy
- interventionNames
- Drug: Docetaxel
- Drug: Prednisone
- type
- NO_INTERVENTION
- label
- Arm 2: Standard of care
- description
- Standard of care
Primary outcomes (1)
- measure
- Number of Participants With Progression-Free Survival
- timeFrame
- Up to 100 months (centralized follow-up)
- description
- The primary objective of this study is to determine whether adding early chemotherapy based on docetaxel plus prednisone compared to standard of care alone reduces disease progression as evidenced by detectable PSA in high risk patients with prostate cancer who have undergone radical prostatectomy.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLin DW, Shih MC, Aronson W, Basler J, Beer TM, Brophy M, Cooperberg M, Garzotto M, Kelly WK, Lee K, McGuire V, Wang Y, Lu Y, Markle V, Nseyo U, Ringer R, Savage SJ, Sinnott P, Uchio E, Yang CC, Montgomery RB. Veterans Affairs Cooperative Studies Program Study #553: Chemotherapy After Prostatectomy for High-risk Prostate Carcinoma: A Phase III Randomized Study. Eur Urol. 2020 May;77(5):563-572. doi: 10.1016/j.eururo.2019.12.020. Epub 2020 Jan 8. PMID 31924316