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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group Identifier:
First received: May 7, 2010
Last updated: October 6, 2016
Last verified: October 2016

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 Intervention
Prostate Cancer
Genetic: gene expression analysis
Genetic: polymorphism analysis
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Serum PSA values at 7 months [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Role of genetic variation in response to therapy [ Time Frame: baseline ] [ Designated as safety issue: No ]

Enrollment: 545
Study Start Date: February 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Genders 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01120262

Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Kathleen A. Cooney, MD University of Michigan Cancer Center
  More Information

Additional Information:
Responsible Party: Southwest Oncology Group Identifier: NCT01120262     History of Changes
Other Study ID Numbers: CDR0000669307  SWOG-S9346A 
Study First Received: May 7, 2010
Last Updated: October 6, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description:

Keywords provided by Southwest Oncology Group:
recurrent prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on October 21, 2016