Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
32 participants
OBSERVATIONAL
2007-05-31
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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1
patients scheduled to receive standard of care with a Radical prostatectomy
Questioners, blood specimens, prostate tissue specimens
You will be asked to fill out a confidential questionnaire asking for information such as medical history, family history of cancer, and potential exposures.
Each patient will provide 7 unstained paraffin sections from prostate biopsies, one tube of blood for serum, and one tube for plasma and buffy coat.
2
patients scheduled to receive standard of care with radiation therapy
Questioners, blood specimens, prostate tissue specimens
You will be asked to fill out a confidential questionnaire asking for information such as medical history, family history of cancer, and potential exposures.
Each patient will provide 7 unstained paraffin sections from prostate biopsies, one tube of blood for serum, and one tube for plasma and buffy coat.
Interventions
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Questioners, blood specimens, prostate tissue specimens
You will be asked to fill out a confidential questionnaire asking for information such as medical history, family history of cancer, and potential exposures.
Each patient will provide 7 unstained paraffin sections from prostate biopsies, one tube of blood for serum, and one tube for plasma and buffy coat.
Questioners, blood specimens, prostate tissue specimens
You will be asked to fill out a confidential questionnaire asking for information such as medical history, family history of cancer, and potential exposures.
Each patient will provide 7 unstained paraffin sections from prostate biopsies, one tube of blood for serum, and one tube for plasma and buffy coat.
Eligibility Criteria
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Inclusion Criteria
* Biopsy performed at the SPORE institution.
* No prior therapy for prostate cancer (patients who receive neoadjuvant therapy after collection of blood and biopsy samples are eligible).
* The patient should have 2 or more cores involved with carcinoma. The minimum amount of tumor submitted should be 5 mm, or at least 40% of the core involved with tumor. (This amount can be made up from 2 positive cores if 1 core is insufficient).
* Patients with clinical stage T1-T2a NXM0 prostate cancer who elect to be treated with RP or XRT (includes external beam radiation, brachytherapy, or both) at the SPORE institution.
* Patients with a nomogram predicted 5-year probability of freedom from biochemical recurrence (Kattan 1998) of less than or equal to 85% (patients with intermediate risk of recurrence).
* Ability and willingness to sign informed consent
Exclusion Criteria
* Previous cancer of any kind except non-melanoma skin cancer
* Previous surgical or minimally invasive treatment for enlarged prostate (e.g. TURP, TUNA, TUIP, laser, microwave)
* Use of anti-androgen drugs during the 6 months prior to diagnosis
* Use of 5-alpha-reductase inhibitors during the 6 months prior to diagnosis
35 Years
MALE
No
Sponsors
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Harvard University
OTHER
Baylor College of Medicine
OTHER
Dana-Farber Cancer Institute
OTHER
University of Washington
OTHER
Fred Hutchinson Cancer Center
OTHER
Johns Hopkins University
OTHER
Mayo Clinic
OTHER
M.D. Anderson Cancer Center
OTHER
Northwestern University
OTHER
University of Michigan
OTHER
University of California, San Francisco
OTHER
University of California, Los Angeles
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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James Eastham, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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UCLA
Los Angeles, California, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
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Related Links
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Memorial Sloan-Kettering Cancer Center
Other Identifiers
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07-053
Identifier Type: -
Identifier Source: org_study_id
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