Laurent Boccon-Gibod1, Peter Albers2, Juan Morote3, Hendrik van Poppel4, Jean de la Rosette5, Arnauld Villers6, Anders Malmberg7, Anders Neijber8, Francesco Montorsi9. 1. Membre de l'Académie de Chirurgie, Expert près les Tribunaux, Paris, France. 2. Department of Urology, Düsseldorf University Hospital, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany. 3. Department of Urology, Vall d'Hebron Hospital, Universitat Autónoma de Barcelona, Barcelona, Spain. 4. Department of Urology, University Hospitals of the KU Leuven, UZ Leuven, Leuven, Belgium. 5. Department of Urology G4-172, AMC University Hospital, Amsterdam, The Netherlands. 6. Department of Urology, CHU Lille, University Lille Nord de France, Lille, France. 7. Ferring Pharmaceuticals A/S, Clin R&D, Global Biometrics, Copenhagen, Denmark. 8. Ferring Pharmaceuticals A/S, Clin R&D, Urology, Copenhagen, Denmark. 9. Cattedra di Urologia, Università Vita e Salute San Raffaele, Milan, Italy. Electronic address: montorsi.francesco@hsr.it.
Abstract
BACKGROUND: Guidelines for prostate cancer treatment suggest that intermittent androgen deprivation (IAD) can be considered for certain patients. OBJECTIVE: To evaluate the efficacy and safety of degarelix as IAD for one or more treatment cycle(s) in prostate cancer patients requiring androgen deprivation. DESIGN, SETTING, AND PARTICIPANTS: This open-label uncontrolled multicenter study included patients with prostate-specific antigen (PSA) >4 to 50 ng/ml or PSA doubling time <24 mo. Induction included 7-mo treatment. Off-treatment period started when PSA was ≤4 ng/ml and lasted up to 24 mo based on PSA and testosterone levels. Treatment was reinitiated when PSA was >4 ng/ml. INTERVENTION: Each induction period included a starting dose of degarelix 240mg, and thereafter 80mg once a month for 6 mo, followed by off-treatment periods. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary end point was time to PSA >4 ng/ml. Secondary end points were subgroup analysis of the primary end point, time to testosterone >0.5 and >2.2 ng/ml, quality of life (QoL), and sexual function during the first off-treatment period. RESULTS AND LIMITATIONS: Of 213 patients in the first induction period, 191 entered the first off-treatment period, 35 patients entered the second induction, and 30 entered the second off-treatment period. Only two patients entered the third cycle. Median time to PSA >4 ng/ml and duration of first off-treatment period was 392 d each. Significant differences in time to PSA >4 ng/ml were observed between subgroups stratified by prognostic factors (previous curative treatment, cancer stage, PSA levels, and Gleason scores). Time to testosterone >0.5 and >2.2 ng/ml was 112 and 168 d, respectively. Change in QoL remained nonsignificant, and sexual function gradually improved during the off-treatment period. Adverse events were fewer during the off-treatment period and subsequent treatment cycles. CONCLUSIONS: IAD with degarelix resulted in an improvement in sexual function commensurate with increased testosterone levels while PSA remained suppressed. The treatment for one treatment cycle or more was well tolerated. PATIENT SUMMARY: Guidelines for prostate cancer treatment suggest that intermittent androgen deprivation (IAD) can be considered for certain patients. IAD with degarelix resulted in improved sexual function commensurate with increased testosterone levels while prostate-specific antigen remained suppressed. The treatment for one treatment cycle or more was well tolerated. TRIAL REGISTRATION: Clinicaltrials.gov identifier NCT00801242.
BACKGROUND: Guidelines for prostate cancer treatment suggest that intermittent androgen deprivation (IAD) can be considered for certain patients. OBJECTIVE: To evaluate the efficacy and safety of degarelix as IAD for one or more treatment cycle(s) in prostate cancerpatients requiring androgen deprivation. DESIGN, SETTING, AND PARTICIPANTS: This open-label uncontrolled multicenter study included patients with prostate-specific antigen (PSA) >4 to 50 ng/ml or PSA doubling time <24 mo. Induction included 7-mo treatment. Off-treatment period started when PSA was ≤4 ng/ml and lasted up to 24 mo based on PSA and testosterone levels. Treatment was reinitiated when PSA was >4 ng/ml. INTERVENTION: Each induction period included a starting dose of degarelix 240mg, and thereafter 80mg once a month for 6 mo, followed by off-treatment periods. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary end point was time to PSA >4 ng/ml. Secondary end points were subgroup analysis of the primary end point, time to testosterone >0.5 and >2.2 ng/ml, quality of life (QoL), and sexual function during the first off-treatment period. RESULTS AND LIMITATIONS: Of 213 patients in the first induction period, 191 entered the first off-treatment period, 35 patients entered the second induction, and 30 entered the second off-treatment period. Only two patients entered the third cycle. Median time to PSA >4 ng/ml and duration of first off-treatment period was 392 d each. Significant differences in time to PSA >4 ng/ml were observed between subgroups stratified by prognostic factors (previous curative treatment, cancer stage, PSA levels, and Gleason scores). Time to testosterone >0.5 and >2.2 ng/ml was 112 and 168 d, respectively. Change in QoL remained nonsignificant, and sexual function gradually improved during the off-treatment period. Adverse events were fewer during the off-treatment period and subsequent treatment cycles. CONCLUSIONS:IAD with degarelix resulted in an improvement in sexual function commensurate with increased testosterone levels while PSA remained suppressed. The treatment for one treatment cycle or more was well tolerated. PATIENT SUMMARY: Guidelines for prostate cancer treatment suggest that intermittent androgen deprivation (IAD) can be considered for certain patients. IAD with degarelix resulted in improved sexual function commensurate with increased testosterone levels while prostate-specific antigen remained suppressed. The treatment for one treatment cycle or more was well tolerated. TRIAL REGISTRATION: Clinicaltrials.gov identifier NCT00801242.
Authors: C Jin; Y Fan; Y Meng; C Shen; Y Wang; S Hu; C Cui; T Xu; W Yu; J Jin Journal: Prostate Cancer Prostatic Dis Date: 2016-09-06 Impact factor: 5.554
Authors: Jyoti Roy; Margaret E White; Falguni Basuli; Ana Christina L Opina; Karen Wong; Morgan Riba; Anita T Ton; Xiang Zhang; Keith H Jansson; Elijah Edmondson; Donna Butcher; Frank I Lin; Peter L Choyke; Kathleen Kelly; Elaine M Jagoda Journal: Mol Imaging Biol Date: 2021-04-23 Impact factor: 3.488