Prostate CancerNCT01120262
S9346A Blood Samples From Patients With Metastatic Prostate Cancer Previously Treated With Bicalutamide and Goserelin
An observational study of Prostate Cancer, run by SWOG Cancer Research Network.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- gene expression analysis, polymorphism analysis and laboratory biomarker analysis
- How many people
- 545 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
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
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- gene expression analysis, polymorphism analysis, laboratory biomarker analysis
- Keywords
- recurrent prostate cancer, stage IV prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expression analysisGenetic
polymorphism analysisGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum PSA values at 7 months
Measured: 7 months
Role of genetic variation in response to therapy
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 545 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kathleen A. Cooney, MD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120262
- Sponsor's protocol ID
- CDR0000669307
- Other IDs
- SWOG-S9346A
- Status last verified
- Oct 2016
- First submitted
- 7 May 2010
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://swog.org/Visitors/Download/Policies/Policy43.pdf
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Germline Polymorphisms Associated With the PSA Response in Men With Metastatic Prostate Cancer Treated With Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT01120262
- Acronym / sponsor ID
- CDR0000669307
- Conditions
- Prostate Cancer
- Keywords
- recurrent prostate cancer, stage IV prostate cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 545 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 10 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- S9346 patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gene expression analysis | Genetic | – |
| polymorphism analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Serum PSA values at 7 months
Time frame: 7 months
Role of genetic variation in response to therapy
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- Individual participant dataSharing planned: Yes. https://swog.org/Visitors/Download/Policies/Policy43.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen A. Cooney, MD principal investigator
University of Michigan Rogel Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by SWOG Cancer Research Network.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum PSA values at 7 months (time frame: 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2016.