Trial in progress: PREPARE—Exploring the activity of pseudoephedrine in treating retrograde ejaculation following retroperitoneal lymph node dissection (RPLND) in survivors of testicular cancer (TC).

Authors

null

Ciara Conduit

Peter MacCallum Cancer Centre, Melbourne, VIC, Australia

Ciara Conduit , Jeremy Howard Lewin , Ie-Wen Sim , Haryana M. Dhillon , Wei Hong , Amanda Hutchinson , Gulfam Ahmad , Nathan Lawrentschuk , Benjamin Thomas , Matt Leonard , Ben Tran

Organizations

Peter MacCallum Cancer Centre, Melbourne, VIC, Australia, Peter MacCallum Cancer Centre and Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia, The University of Melbourne, St Albans, Australia, Faculty of Science, School of Psychology, Centre for Medical Psychology & Evidence-based Decision-making, Psycho-Oncology Cooperative Research Group, The University of Sydney, Sydney, NSW, Australia, Personalised Oncology Division, Walter and Eliza Hall Institute of Medical Research, Parkville, Australia, University of South Australia, Justice & Society, Behaviour-Brain-Body Research Centre, Adelaide, SA, Australia, Andrology, Royal Children's Hospital, Melbourne, VIC, Australia, Royal Melbourne Hospital, The University of Melbourne, Melbourne, VIC, Australia, Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia, Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Sydney, NSW, Australia, Department of Medical Oncology, Peter MacCallum Cancer Centre; and Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia

Research Funding

Other
Australia and New Zealand Urogenital and Prostate Cancer Trials Group

Background: Retrograde ejaculation is a known complication of RPLND occurring due to interruption of sympathetic nerve fibres intraoperatively. Whilst common immediately after surgery, the prevalence of persistent symptoms, and impact on health-related quality-of-life (HRQoL) in TC survivors is unknown. Whilst few effective treatments are available, alpha-sympathomimetics such as pseudoephedrine may form a viable treatment option due to effects on bladder neck constriction at sexual climax propagating antegrade ejaculation. Existing studies have shown pseudoephedrine may be helpful in individuals with retrograde ejaculation; however, these studies have only included a small number (n=5) of patients following RPLND. Methods: In a two-part, single-arm phase 2 clinical trial, participants with a history of TC receiving follow-up after RPLND at least >6 months prior will be invited to participate. In part A (ACTRN12622000537752), eligible participants complete questionnaires regarding survivorship issues including sexual function and fertility to explore the prevalence of retrograde ejaculation and HRQoL. Questionnaires include EORTC QLQ-C30, sexual function items from EORTC QLQ-TC26, Brief Male Sexual Function Inventory and tailored questions focusing on retrograde ejaculation. 15 out of a planned 50 participants (30%) have been enrolled and completed questionnaires. If retrograde ejaculation is reported, eligible participants are invited to enrol in Part B (ACTRN12622000542796), where if the participant has no contraindications to pseudoephedrine, nor are they receiving testosterone replacement and retrograde ejaculation is confirmed during screening, they receive a short course of pseudoephedrine hydrochloride. Pseudoephedrine will be given 60mg QID for one-day, followed by 60mg 4 hours and 1 hour prior to ejaculation to evaluate changes in ejaculation volume, sperm count within (any) antegrade ejaculate and within the post-ejaculatory urine. The primary endpoint is total sperm count in antegrade ejaculate of at least 39 million (5th centile) following treatment. We assumed that pseudoephedrine is ineffective if <10% of participants achieve a normal sperm count in antegrade ejaculate after treatment. Using an exact binomial power analysis for a one-sample proportion test, a sample size of 25 participants provides >80% power to detect 36% (9 out of 25) of participants achieving a normal sperm count against a reference proportion of 10% at the 0.05 significance level. 4 out of a planned 30 participants (16%) have been enrolled. All participants with retrograde ejaculation will be invited to an optional, semi-structured interview to further evaluate impact(s) of retrograde ejaculation on issues around sexual health, relationships, body image and masculinity. Clinical trial information: ACTRN12622000537752, ACTRN12622000542796.

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Abstract Details

Meeting

2023 ASCO Genitourinary Cancers Symposium

Session Type

Trials in Progress Poster Session

Session Title

Trials in Progress Poster Session C: Renal Cell Cancer; Adrenal, Penile, Urethral, and Testicular Cancers

Track

Renal Cell Cancer,Adrenal Cancer,Penile Cancer,Testicular Cancer,Urethral Cancer

Sub Track

Symptoms, Toxicities, Patient-Reported Outcomes, and Whole-Person Care

Clinical Trial Registration Number

ACTRN12622000537752, ACTRN12622000542796

Citation

J Clin Oncol 41, 2023 (suppl 6; abstr TPS432)

DOI

10.1200/JCO.2023.41.6_suppl.TPS432

Abstract #

TPS432

Poster Bd #

N14

Abstract Disclosures