NCT01120262

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
545

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

October 7, 2016

Status Verified

October 1, 2016

Enrollment Period

5 months

First QC Date

May 7, 2010

Last Update Submit

October 6, 2016

Conditions

Keywords

recurrent prostate cancerstage IV prostate cancer

Outcome Measures

Primary Outcomes (2)

  • Serum PSA values at 7 months

    7 months

  • Role of genetic variation in response to therapy

    baseline

Interventions

Eligibility Criteria

Age18 Years - 120 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

S9346 patients

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Gene Expression ProfilingAmplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesDNA FingerprintingPolymerase Chain ReactionNucleic Acid Amplification Techniques

Study Officials

  • Kathleen A. Cooney, MD

    University of Michigan Rogel Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2010

First Posted

May 10, 2010

Study Start

February 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

October 7, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

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