Chemotherapy After Prostatectomy (CAP) For High Risk Prostate Carcinoma
CAP
CSP #553 - Adjuvant Therapy in Prostate Carcinoma Treatment
1 other identifier
interventional
298
2 countries
34
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 prostate-cancer
Started Jun 2006
Longer than P75 for phase_3 prostate-cancer
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2005
CompletedFirst Posted
Study publicly available on registry
August 19, 2005
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedResults Posted
Study results publicly available
June 25, 2018
CompletedJune 25, 2018
May 1, 2018
9.3 years
August 17, 2005
March 26, 2018
May 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Progression-Free Survival
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.
Up to 100 months (centralized follow-up)
Study Arms (2)
Arm 1: Docetaxel and Prednisone
ACTIVE COMPARATORChemotherapy after radical prostatectomy
Arm 2: Standard of care
NO INTERVENTIONStandard of care
Interventions
steroid in combination with chemotherapy agent
Eligibility Criteria
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
- +5 more criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VA Office of Research and Developmentlead
- Sanoficollaborator
Study Sites (34)
VA Medical Center, Birmingham
Birmingham, Alabama, 35233, United States
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, 85723, United States
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
North Little Rock, Arkansas, 72114-1706, United States
VA Medical Center, Long Beach
Long Beach, California, 90822, United States
VA San Diego Healthcare System, San Diego
San Diego, California, 92161, United States
VA Medical Center, San Francisco
San Francisco, California, 94121, United States
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, 90073, United States
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, 06516, United States
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608, United States
VA Medical Center, Miami
Miami, Florida, 33125, United States
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, 33612, United States
VA Medical Center, Augusta
Augusta, Georgia, 30904, United States
Jesse Brown VAMC (WestSide Division)
Chicago, Illinois, 60612, United States
VA Medical Center, Lexington
Lexington, Kentucky, 40502, United States
Overton Brooks VA Medical Center, Shreveport
Shreveport, Louisiana, 71101, United States
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48113, United States
John D. Dingell VA Medical Center, Detroit
Detroit, Michigan, 48201, United States
VA Medical Center, Minneapolis
Minneapolis, Minnesota, 55417, United States
G.V. (Sonny) Montgomery VA Medical Center, Jackson
Jackson, Mississippi, 39216, United States
VA Medical Center, Kansas City MO
Kansas City, Missouri, 64128, United States
New Mexico VA Health Care System, Albuquerque
Albuquerque, New Mexico, 87108-5153, United States
VA Western New York Healthcare System at Buffalo
Buffalo, New York, 14215, United States
VA Medical Center, Durham
Durham, North Carolina, 27705, United States
VA Medical Center, Portland
Portland, Oregon, 97201, United States
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, 15240, United States
Ralph H Johnson VA Medical Center, Charleston
Charleston, South Carolina, 29401-5799, United States
VA Medical Center, Memphis
Memphis, Tennessee, 38104, United States
VA North Texas Health Care System, Dallas
Dallas, Texas, 75216, United States
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, 77030, United States
VA South Texas Health Care System, San Antonio
San Antonio, Texas, 78229, United States
VA Salt Lake City Health Care System, Salt Lake City
Salt Lake City, Utah, 84148, United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108, United States
Wlliam S. Middleton Memorial Veterans Hospital, Madison
Madison, Wisconsin, 53705, United States
VA Medical Center, San Juan
San Juan, 00921, Puerto Rico
Related Publications (1)
Lin 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: 31924316DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Bruce Montgomery
- Organization
- VA Puget Sound Health Care System
Study Officials
- STUDY CHAIR
Daniel Lin
VA Puget Sound Health Care System Seattle Division, Seattle, WA
- STUDY CHAIR
Bruce Montgomery, MD
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The Endpoint Committee will adjudicate evidence for progression, metastasis, and cause of death. The committee will be blinded to the treatment assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2005
First Posted
August 19, 2005
Study Start
June 1, 2006
Primary Completion
October 1, 2015
Study Completion
September 1, 2016
Last Updated
June 25, 2018
Results First Posted
June 25, 2018
Record last verified: 2018-05