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Molecular Studies and Clinical Correlations in Human Prostatic Disease
This study is currently recruiting participants.
Verified by Memorial Sloan-Kettering Cancer Center, April 2009
First Received: December 19, 2007   Last Updated: April 24, 2009   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
Rockefeller University
Flinders Medical Centre
BIOSCIENCES CORPORATION
University of Southern California
Gen-Probe, Incorporated
Genentech
General Electric
Purdue University
Biocept, Inc.
Duke University
Ikonysis, New Haven, CT
Array Genomics
Cold Spring Harbor Laboratory
Information provided by: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00578240
  Purpose

The purpose of this study is to collect tissue samples from normal and cancerous prostates, and blood and urine from men with prostate cancer or prostatic disease. We then store them for use by researchers who study prostate cancer and try to find better ways to prevent it and treat it. We will look for genetic changes in cancer cells and protein markers in these cells. We hope to learn more about what makes some people get prostate cancer, why some cancers are more aggressive than others, and why some cancers respond or resist different treatments. We may also try to grow the tumor cells in the lab. We may find a new treatment for prostate cancer based on this research.


Condition
Prostate Cancer

Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Molecular Studies and Clinical Correlations in Human Prostatic Disease

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To evaluate the biologic heterogeneity of prostatic conditions (both benign and malignant) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate changes in these parameters in patients treated with: Chemotherapy, Hormonal therapy, Radiation therapy, Biologic approaches, or Other targeted therapies, alone or in combination, with respect to clinical outcomes. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Invest host immune resp to ca by assess whether pts have cytotoxic (CD8+) or helper (CD4+) T lymp or antibodies in immune repertoire that can react w specific antigens, or if lymphocytes can be modified ex vivo to gener prost cancer spec immune resp. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To utilize prostatic cancer tissue obtained at the time of a biopsy or surgical procedure, phlebotomy or leukopheresis in short-term culture and in immunocompromised animals to develop immortalized prostate cancer xenografts and cell lines. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To evaluate protein and peptide expression patterns of sera and urine specimens of patients with prostate cancer. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Human tissue, body fluids, and blood


Estimated Enrollment: 2500
Study Start Date: April 1990
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:

The therapeutics program for advanced prostate cancer is based on the hypothesis that the factors contributing to and associated with progression change as the disease evolves. To categorize these changes we now consider the disease as a series of states. The states represent points where an intervention might be considered to prevent cancer from developing, to eliminate established disease, or to delay progression. The states also represent clinically significant milestones that can be used to assess treatment effects. The present study is designed to characterize benign and malignant prostatic conditions representing the time before a cancer diagnosis is established to death from disease, to evaluate the host immune response to tumors, to identify determinants that can be used to define prognosis or for therapeutic attack, and to develop human tumor derived models for laboratory studies. The study involves the acquisition of tumor, bone marrow, blood, and urine from men with benign and malignant prostatic conditions representing the clinical spectrum of the illness. It seeks to define more precisely the interplay between clinical and biologic factors contributing to the development and progression of the disease in the individual so that treatment selection can be refined, treatment effects can be monitored, and more effective regimens designed.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

Inclusion Criteria:

Men with prostate conditions representing the following disease states:

  • No Cancer Diagnosis
  • Clinically Localized Disease
  • Rising PSA
  • Clinical Metastases: Noncastrate
  • Clinical Metastases: Castrate (Measured testosterone < 30 ng/ml)
  • Signed informed consent

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00578240

Contacts
Contact: Howard Scher, MD scherh@mskcc.org

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Rockefeller University
Flinders Medical Centre
BIOSCIENCES CORPORATION
University of Southern California
Gen-Probe, Incorporated
Genentech
General Electric
Purdue University
Biocept, Inc.
Duke University
Ikonysis, New Haven, CT
Array Genomics
Cold Spring Harbor Laboratory
Investigators
Principal Investigator: Howard Scher, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center ( Howard Scher, MD )
Study ID Numbers: 90-040
Study First Received: December 19, 2007
Last Updated: April 24, 2009
ClinicalTrials.gov Identifier: NCT00578240     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
benign
Rising PSA
Clinical Metastases

Study placed in the following topic categories:
Genital Neoplasms, Male
Prostatic Diseases
Neoplasm Metastasis
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Prostatic Diseases
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009