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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00223665 | Effects of IAS in Men With Localized Biochemical Relapsed Prostate Cancer | PHASE2 | COMPLETED | 102 | — | — | Jan 8, 1997 | Sep 6, 2012 | Aug 7, 2018 | 1 | United States |
Monthly Prostate-Specific Antigen (PSA) testing to assess the point at which each patient's disease stops responding to Androgen Deprivation Therapy (ADT). Androgen Independence (AI), also know as Castrate Resistance (CR), was defined as 2 serial rises in PSA while on ADT with Testosterone levels \<50 ng/dL.
Assessment of overall survival measured as median time from completion of first full cycle of IAS until date of death from any cause.
| Arm | Type | Description |
|---|---|---|
| Intermittent Androgen Suppression (IAS) | EXPERIMENTAL | Intermittent Androgen Suppression in 9 month cycles with a combination of a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate. Flutamide dosed as 250mg orally three times a day for 14 days prior to the initiation of Leuprolide Acetate. Leuprolide Acetate dosed as 7.5mg intramuscular (IM) injections once per month for a total of 9 months. |
| Name | Type | Description |
|---|---|---|
| Flutamide | DRUG | Flutamide dosed at 250mg orally three times a day for 14 days prior to the initiation of Leuprolide Acetate. |
| Leuprolide Acetate | DRUG | Leuprolide Acetate dosed at 7.5mg intramuscular (IM) injections once per month for a total of 9 months. |
Inclusion Criteria: * Biochemical relapse (rising PSA) after initial treatment (radiation therapy, brachytherapy, or radical prostatectomy) for histologically or cytologically confirmed adenocarcinoma of the prostate * Clinical stage A2, B, C, D1 * Age: older than 21 years old * Performance status ...