A Phase I Trial of Testosterone in Patients With Progressive Androgen-Independent Prostate Cancer
- Determine the safety and maximum tolerated dose of exogenously administered
testosterone in patients with progressive androgen-independent prostate cancer who have
been in castrate state either surgically or pharmacologically for a minimum of 1 year.
- Assess the changes in expression of androgen receptor and other receptors in human
biopsy specimens or circulating tumor cells before and after this treatment in this
OUTLINE: This is a dose-escalation study.
Patients receive testosterone via an enhanced absorption transdermal system continuously for
28 days. The transdermal patches are changed daily.
Cohorts of 3-6 patients receive a fixed daily dose of testosterone with escalating duration
of exposure until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicities.
Patients are followed at day 1 and at weeks 2 and 4.
PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study.
Primary Purpose: Treatment
Michael Morris, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|