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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

Tracking Information
First Submitted Date December 19, 2007
First Posted Date December 21, 2007
Last Update Posted Date August 25, 2022
Study Start Date April 1990
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures
 (submitted: December 20, 2007)
To evaluate the biologic heterogeneity of prostatic conditions [ Time Frame: 2 years ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: December 20, 2007)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Molecular Studies and Clinical Correlations in Human Prostatic Disease
Official Title Molecular Studies and Clinical Correlations in Human Prostatic Disease
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.
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
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.
Condition Prostate Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: August 18, 2016)
5290
Original Estimated Enrollment
 (submitted: December 20, 2007)
2500
Estimated Study Completion Date December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: Male
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00578240
Other Study ID Numbers 90-040
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Memorial Sloan Kettering Cancer Center
Original Responsible Party Howard Scher, Memorial Sloan-Kettering Cancer Center
Current Study Sponsor Memorial Sloan Kettering Cancer Center
Original Study Sponsor Same as current
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.
Investigators
Principal Investigator: Susan Slovin, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date August 2022