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

October 6, 2016 updated by: Southwest Oncology Group

Germline Polymorphisms Associated With the PSA Response in Men With Metastatic Prostate Cancer Treated With Androgen Deprivation Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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.

Study Type

Observational

Enrollment (Actual)

545

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

S9346 patients

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • Caucasian and African-American participants

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum PSA values at 7 months
Time Frame: 7 months
7 months
Role of genetic variation in response to therapy
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Kathleen A. Cooney, MD, University of Michigan Rogel Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

May 7, 2010

First Submitted That Met QC Criteria

May 7, 2010

First Posted (Estimate)

May 10, 2010

Study Record Updates

Last Update Posted (Estimate)

October 7, 2016

Last Update Submitted That Met QC Criteria

October 6, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000669307
  • SWOG-S9346A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://swog.org/Visitors/Download/Policies/Policy43.pdf

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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