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Original Investigation |

Tadalafil for Prevention of Erectile Dysfunction After Radiotherapy for Prostate Cancer:  The Radiation Therapy Oncology Group [0831] Randomized Clinical Trial

Thomas M. Pisansky, MD1; Stephanie L. Pugh, PhD2; Richard E. Greenberg, MD3; Nadeem Pervez, MB4; Daniel R. Reed, DO5; Seth A. Rosenthal, MD6; Rex B. Mowat, MD7; Adam Raben, MD8; Mark K. Buyyounouski, MD, MS9; Lisa A. Kachnic, MD10; Deborah W. Bruner, PhD, RN11
[+] Author Affiliations
1Mayo Clinic, Rochester, Minnesota
2Radiation Therapy Oncology Group, Philadelphia, Pennsylvania
3Fox Chase Cancer Center, Philadelphia, Pennsylvania
4Cross Cancer Institute, Edmonton, Alberta
5Arizona Center for Cancer Care, Phoenix
6Sutter Medical Group, Sacramento, California
7Toledo Community Hospital Community Clinical Oncology Program, Toledo, Ohio
8Christiana Care Health Service Community Clinical Oncology Program, Newark, Delaware
9Stanford University, Stanford, California
10Boston Medical Center Minority-Based Community Clinical Oncology Program, Boston, Massachusetts
11Emory University, Atlanta, Georgia
JAMA. 2014;311(13):1300-1307. doi:10.1001/jama.2014.2626.
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Published online

Importance  Tadalafil is used to treat erectile dysfunction after prostate cancer treatment, but its role as a preventive agent is undefined.

Objectives  To determine primarily whether tadalafil preserved erectile function in men treated with radiotherapy for prostate cancer, and secondarily to determine whether participant- or partner-reported overall sexual function and sexual and marital satisfaction were affected.

Design, Setting, and Participants  Stratified, placebo-controlled, double-blind, parallel-group study with 1:1 randomization at 76 community-based and tertiary medical sites in the United States and Canada. Two hundred forty-two participants with intact erectile function scheduled to receive radiotherapy for prostate cancer were recruited between November 2009 and February 2012 with follow-up through March 2013.

Interventions  One hundred twenty-one participants were assigned 5 mg of tadalafil daily and 121 were assigned placebo for 24 weeks starting with external radiotherapy (63%) or brachytherapy (37%). Participant-reported International Index of Erectile Function response before radiotherapy and at weeks 2 and 4, between weeks 20 and 24, between weeks 28 and 30, and 1 year thereafter. Participants and partners could respond also to the Sexual Adjustment Questionnaire and to the Locke Marital Adjustment Test before radiotherapy, between weeks 20 and 24 and weeks 28 and 30, and at 1 year.

Main Outcomes and Measures  Primary outcome was off-drug spontaneous erectile function 28 to 30 weeks after radiotherapy started. Secondary end points were spontaneous erection at 1 year; overall sexual function and satisfaction; marital adjustment; and partner-reported satisfaction and marital adjustment at 28 to 30 weeks and 1 year, predictors of tadalafil response; and adverse events.

Results  Among 221 evaluable participants, 80 (79%; 95% CI, 70%-88%) assigned to receive tadalafil retained erectile function between weeks 28 and 30 compared with 61 (74%; 95% CI, 63%-85%) assigned to receive placebo (P = .49); an absolute difference of 5% (95% CI, −9% to 19%). A significant difference was also not observed at 1 year (72%; 95% CI, 60%-84% vs 71%; 95% CI, 59%-84%; P = .93). Tadalafil was not associated with significantly improved overall sexual function or satisfaction; a significant difference was not observed in any domain subscale. Partners of men assigned tadalafil noted no significant effect on sexual satisfaction, and marital adjustment was not significantly improved in participants or partners.

Conclusions and Relevance  Among men undergoing radiotherapy for prostate cancer, daily use of tadalafil compared with placebo did not result in improved erectile function. These findings do not support daily use of tadalafil to prevent erectile dysfunction in these patients.

Trial Registration  clinicaltrials.gov Identifier: NCT00931528

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Figure 1.
Enrollment, Randomization, and Follow-up of the Study Participants

The number of patients screened and assessed for eligibility was not recorded.

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Figure 2.
Sexual Function of Participants Over Timea

Shaded areas represent period during which participants were to take assigned pills. Plot lines indicate group mean values; error bars, 95% CIs.aAssessed by the International Index of Erectile Function (IIEF).bThree participants assigned tadalafil and 1 assigned placebo did not respond to all items.

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