Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00056407 · ClinicalTrials.gov registry record · Phase 3
"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk
A Phase 3 study of Neoplasms Prostate, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 8,231
- Enrollment target
- 20
- Study locations
NCT00056407: Completed Phase 3 study of Neoplasms Prostate, sponsored by GlaxoSmithKline.
NCT00056407 is a Phase 3 study of Neoplasms Prostate that has completed, run by GlaxoSmithKline. The registered enrollment target is 8,231 participants, above the 1,736-participant average among 6 other Neoplasms Prostate trials with a reported enrollment target (374% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00056407, a Phase 3 study of Neoplasms Prostate, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 8,231 participants
- Enrollment target
- 20
- Study locations
Study Summary
This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.
Primary Outcome
Study biopsies consisted of 10 biopsy samples (cores) in a pre-defined pattern. Biopsies were read at the central pathology laboratory (CPL, which processed the majority, 94%, of biopsies). Biopsy cases that were positive for prostate cancer or precancerous lesions (high-grade prostatic intraepithelial neoplasia\[HGPIN\] or typical small acinar proliferation \[ASAP\]) and prostate surgeries were reviewed by the lead pathologist.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dutasteride
Study Locations (20)
Arizona
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Scottsdale
- GSK Investigational Site - Sun City
- GSK Investigational Site - Tucson
- GSK Investigational Site - Tucson
California
- GSK Investigational Site - Anaheim
- GSK Investigational Site - Atherton
- GSK Investigational Site - Culver City
- GSK Investigational Site - Encino
- GSK Investigational Site - Fountain Valley
- GSK Investigational Site - Fresno
Alabama
- GSK Investigational Site - Birmingham
- GSK Investigational Site - Homewood
- GSK Investigational Site - Huntsville
- GSK Investigational Site - Mobile
Arkansas
- GSK Investigational Site - Little Rock
- GSK Investigational Site - Little Rock
Alaska
- GSK Investigational Site - Anchorage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8,231 participants |
| Start Date | 2003-03 |
| Est. Completion | 2009-04 |
| Phase | Phase 3 |
What the finished NCT00056407 record still lists
NCT00056407 is an interventional study that assigns participants to a tested intervention. Its 8,231 participants enrollment target places it among the larger protocols in the corpus, above the 1,736-participant average among 6 other Neoplasms Prostate trials with a reported enrollment target (374% higher).
The record links to 1 condition, with Neoplasms Prostate appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00056407 names 20 study sites across 5 states, led by Arizona, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT00056407 about?
NCT00056407 is a clinical study titled ""REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk". This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will o...
What is the current status of trial NCT00056407?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 8,231 participants. The study started on 2003-03. Estimated completion is 2009-04.
What conditions does trial NCT00056407 study?
This clinical trial studies the following conditions: Neoplasms Prostate.
What interventions are being tested in trial NCT00056407?
The interventions under investigation include: Placebo (DRUG), Dutasteride (DRUG).
Who is sponsoring clinical trial NCT00056407?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00056407 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neoplasms Prostate
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
MRI/Ultrasound Fusion Guided Prostate Cryotherapy
RECRUITING
-
MRI/Ultrasound Fusion Guided Laser Ablation of Prostate Cancer
RECRUITING
-
Investigation of Impact of AI on Prostate Cancer Workflow
RECRUITING · NA
-
First-Time-in-Human Study of GSK5471713 in Adults With mCRPC
RECRUITING · Phase 1
-
A Study of GSK5458514 Administered Alone or In Combination With Other Anti-Cancer Agents in Participants With Prostate Cancer
RECRUITING · Phase 1
-
Prostate Cancer Study In Men Who Have Failed First-Line Androgen Deprivation Therapy
COMPLETED · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06435806 · 8,200 participants · NA
Medical Illustration Design Characteristic Evaluation
- NCT07185828 · 8,286 participants · NA
Informing Low-acuity Emergency Department Patients of Non-emergent Resources (2)
- NCT06184945 · 8,100 participants · NA
Behavioral Economic & Staffing Strategies in the ICU
- NCT05593484 · 8,060 participants · NA
School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Alaska
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia