CSP #553: Adjuvant Therapy in Prostate Carcinoma Treatment - VA Cooperative Studies Program (CSP)
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VA Cooperative Studies Program (CSP)

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CSP #553: Adjuvant Therapy in Prostate Carcinoma Treatment

 

Investigator Access

What's Available




Check with publications for information and a public dataset, data archive, data enclave, or website where data might be available.

Available Documentation

Dates Data are Available

Access Criteria

Study Characteristics

Objectives

The primary endpoint is to determine whether early systemic treatment with adjuvant docetaxel after radical prostatectomy (RP) in patients with high-risk prostate cancer will decrease the 5-year progression rate compared with the standard of care.

Era of Service

All

Population

  • RP with lymphadenectomy and a prostate-specific antigen (PSA) nadir of less than 0.1 ng/mL
  • Enrolled patients will have one of the following features: pathologic Stage T3a disease and Gleason score 7 or greater histologic findings; pathologic Stage T3b-T4 disease; preoperative PSA level greater than 20 ng/mL; or pathologic T2 disease with Gleason score 8 to 10 and positive surgical margins

Study Design

Phase III Randomized Clinical Trial

Time Period

June 2006 – September 2016

Setting

National

N

298 participants

Response Rate

46.9%

Recruitment Method

Unconfirmed

Compensation

Unconfirmed

Data Collected

  • History
  • Physical examination
  • Dietary assessments
  • PSA measurement
  • Metastasis-free survival
  • Cancer-specific survival
  • Overall survival
  • Quality of life and toxicity
  • Interval to the initiation of Androgen Deprivation Therapy (ADT)
  • Prostatic tissue from RP specimens, serum, plasma, nail clippings, DNA

Data Collection Methods

  • In-person assessments (Functional Assessment of Cancer Therapy-Prostate Module, EuroQol 5-Dimension, Dietary assessments)
  • Centralized remote access of medical records
  • All biospecimen samples collected at patient randomization, serum and plasma also collected at recurrence

Funding Source

VA Cooperative Studies Program (CSP)

Contact

Lori Nielsen, Lori.Nielsen@va.gov

Selected Publications

Montgomery B, Lavori P, Garzotto M, Lee K, Brophy M, Thaneemit-Chen S, Kelly W, Basler J, Ringer R, Yu W, Whittemore A, Lin DW. Veterans Affairs Cooperative Studies Program study 553: Chemotherapy after prostatectomy, a phase III randomized study of prostatectomy versus prostatectomy with adjuvant docetaxel for patients with high-risk, localized prostate cancer. Urology. 2008 Sep;72(3):474-80.

More Information

Study ClinicalTrials.gov site

ClinicalTrials.gov Identifier: NCT00132301