Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00558363 | ARTS - AVODART After Radical Therapy For Prostate Cancer Study | PHASE2 | COMPLETED | 294 | — | — | Nov 1, 2007 | Mar 1, 2011 | Mar 21, 2012 | 66 | Estonia, Finland +7 |
Time to PSA doubling is defined as the number of days between the baseline date and the study day of the first post-baseline PSA evaluation date (within treatment period, typically up to 24-month evaluations) on which the PSA value was at least twice as much as the baseline PSA value, and the immediate subsequent value, if available, was at least 85% of two times the baseline value. Participants who never achieved PSA doubling were censored at the last post-baseline, non-missing PSA evaluation.
PSA doubling is defined as the first post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was at least twice as much as the baseline PSA value and was confirmed as such (at least 85% of two times the baseline PSA value) in the immediate subsequent PSA value if one is available.
Time to PSA doubling is defined as the number of days between the baseline date and the study day of the first post-baseline PSA evaluation date within Year 1 (Y1; within treatment period, typically up to 12-month evaluations) on which the PSA value was at least twice as much as the baseline PSA value, and the immediate subsequent value, if available, was at least 85% of two times the baseline value.
PSA doubling is defined as the first post-baseline PSA value (within treatment period, typically up to 12-month evaluations) that was at least twice as much as the baseline PSA value and was confirmed as such (at least 85% of two times the baseline PSA value) in the immediate subsequent PSA value if one is available.
| Arm | Type | Description |
|---|---|---|
| Avodart | EXPERIMENTAL | Patients will receive a 3-month supply of study drug or placebo. Patients will be instructed to take one capsule by mouth once daily. Study medication will be supplied at 3-month intervals during scheduled clinic visits for a total of 24 months. |
| Placebo Arm | PLACEBO_COMPARATOR | Patients will receive a 3-month supply of study drug or placebo. Patients will be instructed to take one capsule by mouth once daily. Study medication will be supplied at 3-month intervals during scheduled clinic visits for a total of 24 months. |
| Name | Type | Description |
|---|---|---|
| Avodart | DRUG | 0.5 mg administered orally once daily |
| placebo | OTHER | Patients will be randomized at Visit 2 in 1:1 ratio to receive either 0.5 mg dutasteride or placebo |
Inclusion Criteria: Patients eligible for enrolment in the study must meet all of the following criteria: * Males \<85 years of age * No clinically relevant abnormal findings on the screening ECG * Patients with asymptomatic PSA failure following radical therapy with curative intent for clinically...