Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Avodart · 1 trial · 2 indications
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...
Avodart is a small molecule being studied for the treatment of prostate neoplasms, specifically prostate cancer after radical treatment. It is an investigational drug in Phase 2 clinical development, and it is not approved for this use.
Avodart is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with prostate cancer.
Avodart is in Phase 2 clinical development. It has completed one Phase 2 trial, the ARTS study, which enrolled 294 participants. The drug is still investigational and has not been approved by regulatory authorities.
Avodart has been studied in one completed Phase 2 clinical trial, NCT00558363, titled "ARTS - AVODART After Radical Therapy For Prostate Cancer Study." This randomized, double-blind, placebo-controlled trial enrolled 294 patients across multiple countries.
Avodart is a small molecule being investigated for prostate cancer. Its specific molecular target has not been disclosed in the available clinical trial information, so its mechanism of action is not described here.