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Molecular Studies and Clinical Correlations in Human Prostatic Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00578240
Recruitment Status : Active, not recruiting
First Posted : December 21, 2007
Last Update Posted : August 25, 2022
Sponsor:
Collaborators:
Rockefeller University
Flinders Medical Centre
University of Southern California
Gen-Probe, Incorporated
Genentech, Inc.
General Electric
Purdue University
Biocept, Inc.
Duke University
Ikonysis
Array Genomics
Cold Spring Harbor Laboratory
Nodality
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 Center
Broad Institute
Weill Medical College of Cornell University
Institute of Cancer Research, United Kingdom
Vitatex Inc.
Serametrix Corporation
Promega Corporation
Creatv Microtech, Inc.
Viatar LLC
Massachusetts Institute of Technology
Advanced Cell Diagnostics
ApoCell, Inc.
Beckman Coulter GmbH
Bioview, Inc.
Clearbridge BioMedics Pte Ltd., Singapore
Cynvenio Biosystems
Exosome Diagnostics, Inc.
Fluxion Biosciences
Foundation Medicine
Universitätsklinikum Hamburg-Eppendorf
Brooklyn ImmunoTherapeutics, LLC
Ohio State University
Palo Alto Research Center
Rarecells
Silicon Biosystems
The Scripps Research Institute
University of Minnesota
Janssen Diagnostics, LLC
University of Regensburg
Innocrin Pharmaceuticals Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
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 or disease
Prostate Cancer

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.

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Study Type : Observational
Actual Enrollment : 5290 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Molecular Studies and Clinical Correlations in Human Prostatic Disease
Study Start Date : April 1990
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine





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.


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00578240


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Rockefeller University
Flinders Medical Centre
University of Southern California
Gen-Probe, Incorporated
Genentech, Inc.
General Electric
Purdue University
Biocept, Inc.
Duke University
Ikonysis
Array Genomics
Cold Spring Harbor Laboratory
Nodality
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 Center
Broad Institute
Weill Medical College of Cornell University
Institute of Cancer Research, United Kingdom
Vitatex Inc.
Serametrix Corporation
Promega Corporation
Creatv Microtech, Inc.
Viatar LLC
Massachusetts Institute of Technology
Advanced Cell Diagnostics
ApoCell, Inc.
Beckman Coulter GmbH
Bioview, Inc.
Clearbridge BioMedics Pte Ltd., Singapore
Cynvenio Biosystems
Exosome Diagnostics, Inc.
Fluxion Biosciences
Foundation Medicine
Universitätsklinikum Hamburg-Eppendorf
Brooklyn ImmunoTherapeutics, LLC
Ohio State University
Palo Alto Research Center
Rarecells
Silicon Biosystems
The Scripps Research Institute
University of Minnesota
Janssen Diagnostics, LLC
University of Regensburg
Innocrin Pharmaceuticals Inc.
Investigators
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Principal Investigator: Susan Slovin, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00578240    
Other Study ID Numbers: 90-040
First Posted: December 21, 2007    Key Record Dates
Last Update Posted: August 25, 2022
Last Verified: August 2022
Keywords provided by Memorial Sloan Kettering Cancer Center:
benign
Rising PSA
Clinical Metastases
90-040
Additional relevant MeSH terms:
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Prostatic Diseases
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Male Urogenital Diseases