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See Latest ArticlesPhase I trial of high-dose exogenous testosterone in patients with castration-resistant metastatic prostate cancer
European Urology, 07/28/09
Morris MJ et al. - In a study to determine the safety of high-dose exogenous testosterone in pts with castration-resistant metastatic prostate cancer (CRMPC), this study shows that state-specific trial designs using contemporary indices of treatment effect can be used safely to test exogenous testosterone in pts with CRMPC.
Methods- Pts with progressive CRMPC who had been castrate for at least 1 yr received 3 times the standard replacement dose of transdermal testosterone.
- Cohorts of 3–6 pts received testosterone for 1 wk, 1 mo, or until disease progression.
- Toxicities, androgen levels, prostate-specific antigen (PSA) assays, computed tomography (CT) scans, bone scintigraphy, positron emission tomography (PET) scans, and metastatic tumor biopsy androgen receptor levels were assessed.
- 12 pts were treated—3 in cohorts 1 and 2 and 6 in cohort 3.
- No pain flares were noted; 1 pt came off study because of epidural disease, which was treated with radiation.
- Average testosterone levels were within normal limits, although dihydrotestosterone (DHT) levels on average were supraphysiologic in cohort 3.
- 1 pt achieved a PSA decline of >50% from baseline.
- No objective responses were seen.
- For cohort 3, median time on treatment was 84 days.
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