Clinical trial NCT00578240: Molecular Studies and Clinical Correlations in Human Prostatic Disease
Official title: Molecular Studies and Clinical Correlations in Human Prostatic Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Keywords: benign
Rising PSA
Clinical Metastases
90-040
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Rockefeller University
name: Flinders Medical Centre
name: University of Southern California
name: Gen-Probe, Incorporated
name: Genentech, Inc.
name: General Electric
name: Purdue University
name: Biocept, Inc.
name: Duke University
name: Ikonysis
name: Array Genomics
name: Cold Spring Harbor Laboratory
name: Nodality
name: Epic Sciences
name: Rutgers Cancer Institute of New Jersey
name: Dana-Farber Cancer Institute
name: Johns Hopkins University
name: M.D. Anderson Cancer Center
name: Oregon Health and Science University
name: University of California, San Francisco
name: University of Chicago
name: University of Michigan
name: University of Washington
name: University of Wisconsin, Madison
name: Fred Hutchinson Cancer Center
name: Broad Institute of MIT and Harvard
name: Weill Medical College of Cornell University
name: Institute of Cancer Research, United Kingdom
name: Vitatex Inc.
name: Serametrix Corporation
name: Promega Corporation
name: Creatv Microtech, Inc.
name: Viatar LLC
name: Massachusetts Institute of Technology
name: Advanced Cell Diagnostics
name: ApoCell, Inc.
name: Beckman Coulter GmbH
name: Bioview, Inc.
name: Clearbridge BioMedics Pte Ltd., Singapore
name: Cynvenio Biosystems
name: Exosome Diagnostics, Inc.
name: Fluxion Biosciences
name: Foundation Medicine
name: Universitätsklinikum Hamburg-Eppendorf
name: Brooklyn ImmunoTherapeutics, LLC
name: Ohio State University
name: Palo Alto Research Center
name: Rarecells
name: Silicon Biosystems
name: The Scripps Research Institute
name: University of Minnesota
name: Janssen Diagnostics, LLC
name: University of Regensburg
name: Innocrin Pharmaceuticals Inc.
First posted: 2007-12-21
Enrollment: 5290
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
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.

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Susan Slovin, MD
role: PRINCIPAL_INVESTIGATOR
References: