At a glance
ClinicalIndex Comparison Record- ✓Biochemical relapse (rising PSA) after initial treatment for prostate adenocarcinoma
- ✓Clinical stage A2, B, C, or D1
- ✓Age older than 21 years
- ✓ECOG performance status 0 or 1
- ✕Abnormal bone scan suggestive of metastatic osseous disease
- ✕Prior hormonal therapy except neoadjuvant androgen suppression ≤3 months completed ≥1 year prior with normal testosterone recovery
- ✕Systemic chemotherapy or curative radiotherapy within 6 months
- ✕Hepatic dysfunction: total bilirubin >2.0 mg/dL, AST >3× upper limit of normal, or LDH >3× upper limit of normal
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective Study of Intermittent Androgen Suppression (IAS) in Men With Localized Prostate Cancer Who Have Biochemical Relapse After Radiation Therapy or Radical Prostatectomy
In Brief
A Phase 2 clinical trial evaluating Flutamide and Leuprolide Acetate for Prostate Cancer. Completed, enrolled 102 participants across 1 site.
Detailed Summary
This study was a prospective analysis in men with localized prostate cancer who had rising Prostate Specific Antigen (PSA) levels after definitive treatment with surgery or radiation. Patients received Intermittent Androgen Suppression (IAS) in 9 month cycles until they became metastatic, became castrate resistant, or withdrew from the study. Subjects were monitored for time to development of Castration Resistant Prostate Cancer (CRPC) and overall survival. They were also monitored for the impact of IAS on a variety of neuro-psychiatric assessments and on bone density.
Study Details
Timeline
Interventions
Flutamide dosed at 250mg orally three times a day for 14 days prior to the initiation of Leuprolide Acetate.
Leuprolide Acetate dosed at 7.5mg intramuscular (IM) injections once per month for a total of 9 months.