Phase 3
N=8,231
"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk
Neoplasms, Prostate
Bottom Line
View on ClinicalTrials.gov: NCT00056407 ↗Enrolled (actual)
8,231
Serious AEs
19.3%
Results posted
Mar 2010
Primary outcome: Primary: Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach) — 578; 435; 280; 224 participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dutasteride (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Male
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach) |
578; 435; 280; 224; 858; 659 | <0.0001 sig |
| PRIMARY Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach) |
578; 435; 280; 224; 858; 659 | <0.0001 sig |
| PRIMARY Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach) |
578; 435; 280; 224; 858; 659 | <0.0001 sig |
| SECONDARY Number of Participants With the Indicated Gleason Score at Diagnosis |
617; 437; 233; 220; 19; 29 | — |
| SECONDARY Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy |
1126; 810; 268; 151; 206; 121 | — |
| SECONDARY Volume of HGPIN at Biopsy |
0.1105; 0.0446 | — |
| SECONDARY Percentage of Core Involved at Diagnosis |
13.4; 12.2 | — |
| SECONDARY Number of Cancer-positive Cores |
1.9; 1.8 | — |
| SECONDARY Treatment Alteration Score |
0.008; 0.019; 0.009; 0.023; 0.017; 0.041 | — |
| SECONDARY Number of Participants Undergoing Intervention (Surgical and Non-surgical) for Prostate Cancer Treatment |
438; 300; 304; 221; 172; 95 | — |
| SECONDARY Adjusted Mean Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 48 |
1.35; -0.46 | — |
| SECONDARY Adjusted Mean Percentage Change From Baseline in Prostate Volume at Months 24 and 48 |
13.0; -17.4; 19.7; -17.5 | — |
| SECONDARY Adjusted Mean Change From Baseline in Maximum Urinary Flow (Qmax) at Months 12, 24, 36, and 48 |
-0.55; 0.27; -0.63; 0.60; -0.74; 0.13 | — |
| SECONDARY Number of Participants Starting Alpha Blockers to Control Benign Prostatic Hyperplasia (BPH) Symptoms |
425; 317; 770; 515 | — |
| SECONDARY Number of Participants With at Least One Event of Acute Urinary Retention (AUR) |
150; 39; 272; 63 | — |
| SECONDARY Number of Participants With at Least One Urinary Tract Infection (UTI) |
196; 131; 164; 83; 360; 214 | — |
| SECONDARY Number of Participants With Post-biopsy Macroscopic Hematuria |
168; 127 | — |
| SECONDARY Number of Participants With Post-biopsy Macroscopic Hematospermia |
78; 53 | — |
| SECONDARY Overall Survival |
29; 32; 77; 70 | — |
| SECONDARY Adjusted Mean Change From Baseline in the Benign Prostatic Hypertrophy (BPH) Impact Index (BII) at Month 48 |
0.44; -0.21 | — |
| SECONDARY Adjusted Mean Change From Baseline in The Medical Outcomes Study Sleep Problems Index 6-item Standard Version (MOS Sleep-6S) at Month 48 |
-0.03; 0.02 | — |
| SECONDARY Adjusted Mean Change From Baseline in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH CPSI) at Month 48 |
0.94; -0.37 | — |
| SECONDARY Adjusted Mean Change From Baseline in Quality of Life Question 8 (QOL Q8) at Month 48 |
-0.06; -0.33 | — |
| SECONDARY Adjusted Mean Change From Baseline in the Problem Assessment Scale of the Sexual Function Index (PASSFI) at Month 48 |
-0.82; -1.5 | — |
| SECONDARY Number of Participants With the Indicated Serum Dihydrotestosterone (DHT) Concentration at Month 48 |
493; 3414; 42; 2210 | — |
| SECONDARY Mean Change From Baseline in Testosterone at Month 48 |
-0.1; 20.0 | <0.001 sig |
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.
Eligibility Criteria
Inclusion criteria
- Informed consent to participate in study.
- Have had a single negative prostate biopsy within 6 months prior to enrollment in study.
- Have a PSA (prostate specific antigen) between 2.5 and 10 if 50-60 years of age; or a PSA between 3.0 and 10 if over age 60.
- Ability and will to participate in study for 4 years.
Exclusion criteria
- More than one previous negative prostate biopsy.
- History of prostate cancer.
- Previous prostate surgery.
- Inability to urinate requiring the need of a catheter during the previous 2 years.
- Any condition (other than benign prostatic hypertrophy) which may result in urinary symptoms or changes in urine flow rate.
- Cancer within previous 5 years (other than basal or squamous cell cancers of the skin).
- Any unstable serious medical condition.
- Use within the past 12 months of finasteride (Proscar or Propecia), dutasteride (Avodart), testosterone, or drugs that can block the action of male hormones.
Data sourced from ClinicalTrials.gov (NCT00056407). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.