Molecular Studies and Clinical Correlations in Human Prostatic Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
Rockefeller University
Flinders Medical Centre
Aureon Biosciences, Inc.
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
Nodality, Inc.
Epic Sciences
Rutgers Cancer Institute of New Jersey
Dana-Farber Cancer Institute
Johns Hopkins University
M.D. Anderson Cancer Center
Oregon Health and Science University
University of California, San Francisco
University of Chicago
University of Michigan
University of Washington
University of Wisconsin, Madison
Fred Hutchinson Cancer Research Center
The Broad Institute, Cambridge MA
Weill Medical College of Cornell University
Institute of Cancer Research, United Kingdom
Vitatex Inc.
Serametrix Corporation, Carlsbad, CA
Promega Corporation, Madison, WI
Viamet Pharmaceuticals, Inc.
Creatv MicroTech, Inc., Potomac, MD
Viatar LLC
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00578240
First received: December 19, 2007
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

The Genitourinary Oncology/Urology Services at Memorial Sloan-Kettering Cancer Center (MSKCC) participates in research for the control, treatment, and cure of cancer. The purpose of this study is to collect normal and cancerous tissues, in addition to blood, and other body fluid samples from men with prostate cancer or prostatic disease. These samples may be stored for future use or used immediately by researchers who study prostate cancer and try to find better ways to diagnose, prevent, and treat it. We will look for genetic changes and protein markers on 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 to 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: Observational Model: Case-Only
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:

Biospecimen Retention:   Samples With DNA

Human tissue, body fluids, and blood Fresh tissue will be obtained from patients undergoing a biopsy or surgical procedure as part of their standard therapy or as part of an investigational research protocol. Previously stored pathology specimens may also be used. Peripheral blood, bone marrow, urine, and other bodily fluids and samples will also be obtained as needed.


Estimated Enrollment: 2500
Study Start Date: April 1990
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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. 1 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.

  Eligibility

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

All patients meeting the eligibility criteria and receiving or seeking prostate cancer treatment in the Genitourinary Oncology/Urology Services will be approached by a consenting professional at a suitable point in their clinical course prior to biospecimen collection.

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 (Testosterone ≤ 50 ng/ml)
  • Signed informed consent

Exclusion Criteria:

-Patients without any prostate related problems.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Susan Slovin, MD 646-422-4470
Contact: James Eastham, MD 646-422-4390

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
Aureon Biosciences, Inc.
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
Nodality, Inc.
Epic Sciences
Rutgers Cancer Institute of New Jersey
Dana-Farber Cancer Institute
Johns Hopkins University
M.D. Anderson Cancer Center
Oregon Health and Science University
University of California, San Francisco
University of Chicago
University of Michigan
University of Washington
University of Wisconsin, Madison
Fred Hutchinson Cancer Research Center
The Broad Institute, Cambridge MA
Weill Medical College of Cornell University
Institute of Cancer Research, United Kingdom
Vitatex Inc.
Serametrix Corporation, Carlsbad, CA
Promega Corporation, Madison, WI
Viamet Pharmaceuticals, Inc.
Creatv MicroTech, Inc., Potomac, MD
Viatar LLC
Investigators
Principal Investigator: Susan Slovin, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00578240     History of Changes
Other Study ID Numbers: 90-040
Study First Received: December 19, 2007
Last Updated: September 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
benign
Rising PSA
Clinical Metastases
90-040

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

ClinicalTrials.gov processed this record on September 14, 2014