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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01120262
• Other study ID #: CDR0000669307
• Secondary ID: SWOG-S9346A
• Status: Completed
• Phase: N/A
• First received: May 7, 2010
• Last updated: October 6, 2016
• Start date: February 2010
• Est. completion date: July 2010

Study information

• Verified date: October 2016
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 545
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Genetic:
• gene expression analysis

• polymorphism analysis

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum PSA values at 7 months		7 months	No
Primary	Role of genetic variation in response to therapy		baseline	No

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database