The Utility of PSADv (PSA Density Velocity) While on Dutasteride for Predicting Prostate Cancer Incidence and Grade and Stage
PSADv
Retrospective Review of Reduce Data to Determine the Utility of PSADv While on Dutasteride for Predicting Prostate Cancer Incidence and Grade and Stage
1 other identifier
observational
6,600
1 country
1
Brief Summary
This is a review of previously published data from a large prostate cancer prevention study known as REDUCE. It is the investigators intention to review whether prostate specific antigen (PSA) velocity (change over time) will predict the presence of prostate cancer and its grade and stage (severity).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2012
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2011
CompletedFirst Posted
Study publicly available on registry
December 2, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedDecember 2, 2011
November 1, 2011
3 months
November 30, 2011
December 1, 2011
Conditions
Keywords
Eligibility Criteria
Men with PSA elevation (\>=4), 50-74 years old with negative biopsy of the prostate at study entry
You may qualify if:
- Men,
- years old with elevated PSA (\>=4) along with negative entry biopsy of the prostate who had a subsequent biopsy by 24 months.
You may not qualify if:
- Any positive biopsy of the prostate indicative of cancer upon entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Urology, Brown University
Providence, Rhode Island, 02903, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven I Cohen, MD
University Urological Associates Inc.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2011
First Posted
December 2, 2011
Study Start
January 1, 2012
Primary Completion
April 1, 2012
Study Completion
May 1, 2012
Last Updated
December 2, 2011
Record last verified: 2011-11