MP14-06: Impact of abiraterone on sexual function in men with advanced prostate cancer: A meta-analysis of RCTs
Friday, May 3, 2024 1:00 PM to 3:00 PM · 2 hr. (US/Central)
304B
Abstract
Information
Full Abstract and Figures
Author Block
Alec Zhu, Aaron Brant*, New York, NY, Xian Wu, Camilo A. Gallo, Cleveland, OH, Manish Kuchakulla, Adithya Balasubramanian, Lina Posada, Leo Dreyfuss, Mary O. Strasser, Tenny R. Zhang, Robert Fisch, Brandon M. Wahba, Gal Wald, New York, NY, Jonathan E. Shoag, Cleveland, OH
Introduction
New anti-androgens demonstrate improved survival in men with advanced prostate cancer. However, the impact of these medications on sexual function is unclear. We used quality-of-life data from randomized clinical trials (RCTs) evaluating abiraterone acetate (AA) in men with metastatic prostate cancer to characterize the effect of anti-androgens on erectile and sexual function.
Methods
We identified seven clinical trials (COU301, COU302, PCR2023, PCR3011, PCR4011, PRO3001, PRO3002) within the Yale University Open Data Access (YODA) repository evaluating AA in patients with metastatic castration-sensitive or castration-resistant prostate cancer. Patients who completed the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire before and after treatment were included. Responses to question ‘BL5’ corresponded to erectile function, and responses to question ‘GS7’ corresponded to sexual function satisfaction. The main outcomes were changes in erectile function and sexual satisfaction sub-scores from baseline to 3, 6, and 12 months. To compare the effect of AA between treatment and control groups, meta-analysis was performed in the five RCTs to estimate the standardized mean differences (SMD) in change of FACT-P sub-scores between the two treatment arms.
Results
A total of 7,353 patients were identified from the seven trials within YODA. The SMDs in erectile function (A) and sexual satisfaction (B) scores at 3, 6, and 12 months between the treatment and control groups were determined for each trial (Figure). Heterogeneity was assessed and meta-analysis of the RCTs demonstrated no statistically significant changes in erectile function or sexual satisfaction sub-scores at 3 and 6 months between the two treatment arms. At 12 months, overall SMDs were -0.02 (95% CI -0.12, 0.08) for erectile function and -0.05 (95% CI -0.21, 0.11) for sexual satisfaction with a fixed-effects model, and overall SMDs were -0.02 (95% CI -0.20, 0.16) for erectile function and -0.05 (95% CI -0.21, 0.11) for sexual satisfaction with a random-effects model.
Conclusions
Meta-analysis of quality-of-life data from RCTs reveals AA does not significantly impact erectile function or sexual satisfaction relative to control treatments in men with metastatic prostate cancer.
Source Of Funding
N/A
Author Block
Alec Zhu, Aaron Brant*, New York, NY, Xian Wu, Camilo A. Gallo, Cleveland, OH, Manish Kuchakulla, Adithya Balasubramanian, Lina Posada, Leo Dreyfuss, Mary O. Strasser, Tenny R. Zhang, Robert Fisch, Brandon M. Wahba, Gal Wald, New York, NY, Jonathan E. Shoag, Cleveland, OH
Introduction
New anti-androgens demonstrate improved survival in men with advanced prostate cancer. However, the impact of these medications on sexual function is unclear. We used quality-of-life data from randomized clinical trials (RCTs) evaluating abiraterone acetate (AA) in men with metastatic prostate cancer to characterize the effect of anti-androgens on erectile and sexual function.
Methods
We identified seven clinical trials (COU301, COU302, PCR2023, PCR3011, PCR4011, PRO3001, PRO3002) within the Yale University Open Data Access (YODA) repository evaluating AA in patients with metastatic castration-sensitive or castration-resistant prostate cancer. Patients who completed the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire before and after treatment were included. Responses to question ‘BL5’ corresponded to erectile function, and responses to question ‘GS7’ corresponded to sexual function satisfaction. The main outcomes were changes in erectile function and sexual satisfaction sub-scores from baseline to 3, 6, and 12 months. To compare the effect of AA between treatment and control groups, meta-analysis was performed in the five RCTs to estimate the standardized mean differences (SMD) in change of FACT-P sub-scores between the two treatment arms.
Results
A total of 7,353 patients were identified from the seven trials within YODA. The SMDs in erectile function (A) and sexual satisfaction (B) scores at 3, 6, and 12 months between the treatment and control groups were determined for each trial (Figure). Heterogeneity was assessed and meta-analysis of the RCTs demonstrated no statistically significant changes in erectile function or sexual satisfaction sub-scores at 3 and 6 months between the two treatment arms. At 12 months, overall SMDs were -0.02 (95% CI -0.12, 0.08) for erectile function and -0.05 (95% CI -0.21, 0.11) for sexual satisfaction with a fixed-effects model, and overall SMDs were -0.02 (95% CI -0.20, 0.16) for erectile function and -0.05 (95% CI -0.21, 0.11) for sexual satisfaction with a random-effects model.
Conclusions
Meta-analysis of quality-of-life data from RCTs reveals AA does not significantly impact erectile function or sexual satisfaction relative to control treatments in men with metastatic prostate cancer.
Source Of Funding
N/A
