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Flutamide · 1 trial · 1 indication
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 ...
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Flutamide is used for prostate cancer. It is a small molecule oncology drug being developed by Sanofi. Flutamide is currently in Phase 2 clinical development for this indication.
Sanofi (ticker: SNY) is developing Flutamide. The drug is a small molecule being studied for the treatment of prostate cancer.
Flutamide is in Phase 2 clinical development. It is an investigational drug for prostate cancer and is not yet approved by regulatory authorities.
Flutamide has one completed clinical trial, NCT00223665, titled 'Effects of IAS in Men With Localized Biochemical Relapsed Prostate Cancer.' This Phase 2 study enrolled 102 male participants aged 21 years and older in the United States.
The clinical trial NCT00223665 refers to IAS, which is the investigational agent being studied. The trial title mentions IAS, and Flutamide is the drug being evaluated in this study for prostate cancer.