Prostate Cancer Prospective Cohort

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT00937586
• Collaborator: Johns Hopkins University (Other), National Cancer Institute (NCI) (NIH), Wake Forest University (Other)
• Enrollment: 1,937
• Location: 1
• Duration (Months): 301
• Patients Per Site Per Month: 6.4

Study Details

Study Description

Brief Summary

The overall purpose of this research is to determine if certain genes increase the chance of developing prostate cancer and once diagnosed increase the chance of the prostate cancer spreading to other parts of the body.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer

Detailed Description

DNA will be isolated from each person and then studied for the presence of certain genes that may increase the chance of developing prostate cancer. Certain genes will also be studied in patients with known prostate cancer to determine if they increase the chance of cancer spreading to other parts of the body and decrease one's chance of being cured. Small differences in genes can slightly affect their ability to function. While these differences are normal, they may influence the way the cancer responds to therapy. An understanding of which genes increase (or decrease) the chance of being cured of a disease, such as prostate cancer, will improve our ability to take care of patients more effectively.

A second purpose of this study is to collect blood and cancer tissue for future studies. While the small differences in genes may be the best marker of bad cancer, it is also possible that proteins in blood or tumor may be a better marker.

Study Design

• Study Type: Observational
• Actual Enrollment: 1937 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prostate Cancer Prospective Cohort
• Study Start Date: May 1, 2000
• Anticipated Primary Completion Date: Jun 1, 2025
• Anticipated Study Completion Date: Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Newly diagnosed patients Patients with newly diagnosed prostate cancer.

Outcome Measures

Primary Outcome Measures

1. Ability to recognize increased risk of metastatic prostate cancer based on specific genetic polymorphisms. [At the time of prostate cancer diagnosis]

Secondary Outcome Measures

1. Ability to predict risk for treatment failure based on analysis of specific polymorphisms. [At the time of prostate cancer diagnosis]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Newly diagnosed patients: 1. newly diagnosis of prostate cancer 2. untreated except for neoadjuvant systemic therapy.

Exclusion Criteria:

• Newly diagnosed patients: 1. inability to give informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine
• Johns Hopkins University
• National Cancer Institute (NCI)
• Wake Forest University

Investigators

• Principal Investigator: Bettina Drake, PhD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT00937586
• Other Study ID Numbers: HRPO#00-0327; R01CA112028
• First Posted: Jul 13, 2009
• Last Update Posted: Mar 10, 2022
• Last Verified: Mar 1, 2022

• Keywords provided by Washington University School of Medicine: Metastatic Prostate Cancer; Prostate Cancer Risk Assessment
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Mar 10, 2022