Prostate Biomarker Study - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center Harvard University Baylor College of Medicine Dana-Farber Cancer Institute University of Washington Fred Hutchinson Cancer Research Center Johns Hopkins University Mayo Clinic M.D. Anderson Cancer Center Northwestern University University of Michigan University of California, San Francisco University of California, Los Angeles
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00574899

Purpose

Radical Prostatectomy (removal of the prostate) or radiation therapy provide excellent outcomes for patients with localized (confined to one area) disease, yet there is still no effective treatment once the disease has spread beyond the prostate gland. Typically, a serum PSA test is done to diagnose prostate cancer. Following diagnosis, a prostate biopsy and other tests help to classify the patient's disease according to the likelihood of a recurrence. However, these assessments are imperfect. There is a need to identify and evaluate prostate biomarkers that will provide exact information regarding the likelihood of a recurrence (prediction) of prostate cancer.

Condition	Intervention
Prostate Cancer	Other: Questioners, blood specimens, prostate tissue specimens

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Multi-Institutional Inter-SPORE Prostate Biomarker Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

Coll & contrib bio spec to Inter-SPORE Prostate Biomarker Study men with clinical localized prostate ca sched to get standard of care therapy for localized prost ca, either radical prostatectomy, RT therapy [ Time Frame: pre-treatment and at yearly intervals during follow-up. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To participate in the IPBS by conducting a prospective analysis of the prognostic utility of serum hK2 in predicting biochemical recurrence after definitive local therapy for prostate cancer. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

tissue, serum, plasma, and lymphocytes

Estimated Enrollment:	700
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 patients scheduled to receive standard of care with a Radical prostatectomy	Other: 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	Other: 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.

Detailed Description:

The Inter-SPORE Prostate Biomarkers Study (IPBS) was established to prospectively collect and analyze biological specimens to predict and validate outcomes after treatment for prostate cancer. The study population will consist of patients scheduled to receive standard of care therapy for localized prostate cancer, either radical prostatectomy (RP) or radiation therapy (XRT; includes external beam radiation, brachytherapy, or both). Seven hundred (700) patients (350 RP, 350 XRT) will be recruited from 11 SPORE sites over a two-year interval. We will collect serum, plasma, lymphocytes, and prostate tissue samples for distribution to collaborating biomarker validation sites at other prostate SPOREs, along with clinical and epidemiologic data.

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

11 cancer centers in the USA

Criteria

Inclusion Criteria:

Males, 35 years of age or older, with histologically confirmed prostate adenocarcinoma, that is clinically localized to the prostate gland.
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:

Participation in a therapeutic clinical trial with an experimental agent.
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574899

Contacts

Contact: James Eastham, MD		easthamj@mskcc.org
Contact: Hans Lilja, MD, PhD		liljah@mskcc.org

Locations

United States, California
UCLA	Recruiting
Los Angeles, California, United States, 90095
Contact: Robert Reiter, MD 310-794-7724 rreiter@mednet.ucla.edu
Principal Investigator: Robert Reiter, MD
United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10021
Contact: James Eastham, MD 646-422-4390 easthamj@mskcc.org
Contact: Hans Lilja, MD 212-639-6982 liljah@mskcc.org
Principal Investigator: James Eastham, MD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Harvard University

Baylor College of Medicine

Dana-Farber Cancer Institute

University of Washington

Fred Hutchinson Cancer Research Center

Johns Hopkins University

Mayo Clinic

M.D. Anderson Cancer Center

Northwestern University

University of Michigan

University of California, San Francisco

University of California, Los Angeles

Investigators

Principal Investigator:

James Eastham, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( James Eastham, MD )
Study ID Numbers:	07-053
Study First Received:	December 13, 2007
Last Updated:	May 22, 2009
ClinicalTrials.gov Identifier:	NCT00574899 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Prostate

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009