Phase 4
Completed N=302
Assessment Of Dutasteride (AVODART) In Extending The Time To Progression Of Low-Risk, Localized Prostate Cancer In Men
Neoplasms, Prostate
Source: ClinicalTrials.gov NCT00363311 ↗
Enrolled (actual)
302
Serious AEs
14.9%
Results posted
Jun 2011
Primary outcomePrimary: Number of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression — 50; 32; 71; 54 participants — p=0.009
Summary
The purpose of this study is to examine the effect of dutasteride on the inhibition of low-risk, localized prostate cancer progression in men who would otherwise receive no active therapy (expectant management).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression |
50; 32; 71; 54 | 0.009 sig |
| SECONDARY Number of Participants With Therapeutic Progression |
11; 5; 20; 11 | 0.13 |
| SECONDARY Number of Participants With Pathologic Progression |
39; 27; 51; 43 | 0.031 sig |
| SECONDARY Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis |
111; 111; 25; 29 | 0.65 |
| SECONDARY Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis for Their Final Biopsy |
105; 90; 31; 50 | 0.024 sig |
| SECONDARY Number of Cancer-positive Cores in a 12-core Biopsy |
1.6; 1.6; 2.8; 2.2; 2.0; 2.0 | — |
| SECONDARY Change From Baseline in the Number of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3 |
1.1; 0.6; 2.0; 2.0; 3.0; 2.5 | — |
| SECONDARY Mean Percentage of Cancer-positive Cores in a 12-core Biopsy |
14.3; 14.5; 23.7; 19.0; 16.5; 17.3 | — |
| SECONDARY Change From Baseline in the Percentage of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3 |
8.4; 3.7; 4.1; 1.5; 10.0; 6.0 | — |
| SECONDARY Cumulative Length of Cancer Tumor Core |
2.0; 2.1; 6.2; 4.8; 3.7; 3.8 | — |
| SECONDARY Change From Baseline in the Cumulative Length of Cancer Tumor Core at Years 1.5, 3, and 0-3 |
3.9; 2.5; 1.8; 1.5; 4.8; 3.8 | — |
| SECONDARY Number of Participants With the Indicated Change From Baseline in Gleason Score (GS) on Repeat Biopsy at Year 1.5 |
6; 21; 51; 58; 24; 21 | 0.20 |
| SECONDARY Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3 |
31; 50; 31; 50; 83; 71 | 0.039 sig |
| SECONDARY Number of Participants With the Indicated Total Gleason Score |
31; 50; 0; 0; 83; 71 | — |
| SECONDARY Number of Biopsies With the Indicated Clinical Tumor Stage at Baseline |
125; 117; 30; 29; 0; 1 | 0.80 |
| SECONDARY Number of Post-baseline Biopsies With the Indicated Change From Baseline in Clinical Stage |
53; 53; 13; 5 | 0.12 |
| SECONDARY Prostate Volume (PV) LOCF |
44.2; 43.2; 43.1; 43.3; 43.0; 43.1 | — |
| SECONDARY Change From Baseline in Prostate Volume at Years 1.5 and 3 |
0.7; -9.5; 3.3; -8.6 | — |
| SECONDARY Percent Change From Baseline in Prostate Volume at Years 1.5 and 3 |
3.7; -19.8; 7.7; -18.0 | — |
| SECONDARY Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) |
11.0; 11.3; 11.4; 11.4; 10.9; 10.4 | — |
| SECONDARY Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF |
0.4; 0.3; -0.0; -0.8; -0.1; -1.4 | — |
| SECONDARY Total MAX-PC Anxiety Subscale Score Related to PSA Testing |
7.1; 7.3; 7.5; 7.5; 7.0; 6.9 | — |
| SECONDARY Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF) |
0.7; 0.3; 0.1; -0.3; 0.1; -0.6 | — |
| SECONDARY Total MAX-PC Fear of Recurrence Subscale Score |
3.4; 3.4; 3.2; 3.3; 3.3; 2.9 | — |
| SECONDARY Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF) |
-0.2; -0.0; -0.2; -0.5; -0.1; -0.7 | — |
| SECONDARY Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score |
129.9; 131.3; 126.9; 130.2; 126.6; 129.0 | — |
| SECONDARY Change From Baseline in Total FACT-P Score (LOCF) |
-4.2; -1.2; -3.7; -2.3 | — |
| SECONDARY Percent Change From Baseline in Total FACT-P Score (LOCF) |
-2.8; -0.2; -1.8; -1.0 | — |
| SECONDARY Change From Baseline in FACT-P Physical Well-Being Subscale Score (LOCF) |
-0.4; -0.2; -0.3; -0.3 | — |
| SECONDARY Change From Baseline in FACT-P Social Well-Being Subscale Score (LOCF) |
-1.4; -0.6; -1.1; -1.2 | — |
Eligibility Criteria
Inclusion criteria
- Must be male ≥48 and ≤82 years of age
- Have biopsy proven, low-risk, localized prostate cancer and active in expectant management not more than 14 months. [For the purposes of assessing subject eligibility a diagnostic biopsy must have included at least 10 cores, ( 80 cc
- Subject has had prior prostatic surgery including Transurethral needle ablation of the prostate (TUNA), TURP, Transurethral incision of the prostate (TUIP), laser treatment, thermotherapy, balloon dilatation, prosthesis, and ultrasound ablation within 3 months of enrolment
- Severe Benign Prostatic Hyperplasia (BPH) symptoms as manifested by International Prostate Symptom Score (IPSS) symptom score (calculated using the first 7 questions only) of ≥25 or >20 if already on alpha blocker therapy.
- Participation in any investigational or marketed drug trial within the 30 days prior to the first dose of study drug or anytime during the study period.
- Any unstable serious co-existing medical condition(s) including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.
- Abnormal liver function test (greater than 2 times the upper limit of normal for alanine aminotransferase [ALT], aspartate aminotransferase [AST], or alkaline phosphatase [ALP]); or bilirubin >1.5 times the upper limit of normal.
- Serum creatinine >1.5 times the upper limit of normal.
- History of another malignancy within five years that could affect the diagnosis of prostate cancer.
- History or current evidence of drug or alcohol abuse within the last 12 months.
- History of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject.
- Known hypersensitivity to any 5α-reductase inhibitor or to any drug chemically related to dutasteride.
Data sourced from ClinicalTrials.gov (NCT00363311). 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. Informational only — not medical advice.