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S9346A Blood Samples From Patients With Metastatic Prostate Cancer Previously Treated With Bicalutamide and Goserelin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01120262
Recruitment Status : Completed
First Posted : May 10, 2010
Last Update Posted : October 7, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:

RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is studying blood samples from patients with metastatic prostate cancer previously treated with bicalutamide and goserelin.

Condition or disease Intervention/treatment
Prostate Cancer Genetic: gene expression analysis Genetic: polymorphism analysis Other: laboratory biomarker analysis

Detailed Description:


  • To test the association between serum PSA response (< 4 ng/mL) at 7 months with inherited variability of germline single nucleotide polymorphisms, in a set of candidate genes, in patients with metastatic prostate cancer treated with combination induction androgen-deprivation therapy comprising bicalutamide and goserelin.

OUTLINE: DNA extracted from whole blood or serum samples is analyzed for inherited variability of germline single nucleotide polymorphisms.

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Study Type : Observational
Actual Enrollment : 545 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Germline Polymorphisms Associated With the PSA Response in Men With Metastatic Prostate Cancer Treated With Androgen Deprivation Therapy
Study Start Date : February 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Primary Outcome Measures :
  1. Serum PSA values at 7 months [ Time Frame: 7 months ]
  2. Role of genetic variation in response to therapy [ Time Frame: baseline ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
S9346 patients


  • Diagnosed with metastatic prostate cancer
  • Accrued to SWOG-9346 and received androgen-deprivation therapy (ADT)
  • Must have serum PSA values from the beginning to the end of 8 courses of ADT
  • Must have whole blood or serum samples available


  • Caucasian and African-American participants


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01120262

Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
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Principal Investigator: Kathleen A. Cooney, MD University of Michigan Rogel Cancer Center
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Responsible Party: Southwest Oncology Group Identifier: NCT01120262    
Other Study ID Numbers: CDR0000669307
First Posted: May 10, 2010    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:
Keywords provided by Southwest Oncology Group:
recurrent prostate cancer
stage IV prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases