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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01120262
Enrollment
545
Registered
2010-05-10
Start date
2010-02-28
Completion date
2010-07-31
Last updated
2016-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer, stage IV prostate cancer

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.

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.

Interventions

GENETICgene expression analysis
GENETICpolymorphism analysis
OTHERlaboratory biomarker analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
SWOG Cancer Research Network
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Serum PSA values at 7 months7 months
Role of genetic variation in response to therapybaseline

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026