Jack M Zuckerman1, Gregg Eure1, John Malcolm1, Lilian Currie1, Robert Given2. 1. Urology of Virginia, Department of Urology, Eastern Virginia Medical School, Norfolk, VA. 2. Urology of Virginia, Department of Urology, Eastern Virginia Medical School, Norfolk, VA. Electronic address: givenrw@aol.com.
Abstract
OBJECTIVE: To evaluate for a possible testosterone surge during transition of therapy from degarelix to leuprolide. METHODS: We conducted an investigator-initiated, prospective, single-arm, open-label trial for evaluation of a potential testosterone surge during a transition of therapy from degarelix to leuprolide. Study patients were administered 3 monthly depot injections of degarelix, followed by one 3-month depot injection of leuprolide. A rise in serum testosterone was considered clinically relevant in previously castrate patients whose testosterone rose above 50 ng/dL. RESULTS: Forty-five patients aged 59-86 years were included in the final analysis after completing the entire 6-month study. Nineteen percent of patients had received prior androgen deprivation therapy, and 10% had metastatic disease. Mean serum testosterone was reduced from a baseline of 374.6 ± 155.7 ng/dL to 16.5 ± 8.1 ng/dL, and prostate-specific antigen reduced from 23.8 ± 55.8 ng/mL to 1.6 ± 3.7 ng/mL after 3 months of treatment with degarelix. On transition from degarelix to leuprolide (day 90), there was a rise in testosterone from the nadir of 16.5 ng/dL to a peak of 25.8 ng/dL (P = .0005), occurring at day 93. Four patients (8.9%) experienced a testosterone surge with a mean peak serum testosterone of 80.7 ng/dL; all 4 returned to castrate levels within 7 days, and all remained asymptomatic throughout the testosterone fluctuation. CONCLUSION: Fluctuations in serum testosterone after this transition of therapy were mild and short-lived with only 8.9% of men experiencing testosterone elevations to noncastrate levels.
OBJECTIVE: To evaluate for a possible testosterone surge during transition of therapy from degarelix to leuprolide. METHODS: We conducted an investigator-initiated, prospective, single-arm, open-label trial for evaluation of a potential testosterone surge during a transition of therapy from degarelix to leuprolide. Study patients were administered 3 monthly depot injections of degarelix, followed by one 3-month depot injection of leuprolide. A rise in serum testosterone was considered clinically relevant in previously castrate patients whose testosterone rose above 50 ng/dL. RESULTS: Forty-five patients aged 59-86 years were included in the final analysis after completing the entire 6-month study. Nineteen percent of patients had received prior androgen deprivation therapy, and 10% had metastatic disease. Mean serum testosterone was reduced from a baseline of 374.6 ± 155.7 ng/dL to 16.5 ± 8.1 ng/dL, and prostate-specific antigen reduced from 23.8 ± 55.8 ng/mL to 1.6 ± 3.7 ng/mL after 3 months of treatment with degarelix. On transition from degarelix to leuprolide (day 90), there was a rise in testosterone from the nadir of 16.5 ng/dL to a peak of 25.8 ng/dL (P = .0005), occurring at day 93. Four patients (8.9%) experienced a testosterone surge with a mean peak serum testosterone of 80.7 ng/dL; all 4 returned to castrate levels within 7 days, and all remained asymptomatic throughout the testosterone fluctuation. CONCLUSION: Fluctuations in serum testosterone after this transition of therapy were mild and short-lived with only 8.9% of men experiencing testosterone elevations to noncastrate levels.