Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Prostate Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, multicenter, assessor-blinded randomized trial comparing a multimodal prehabilitation and rehabilitation program to standard care for men undergoing robot-assisted radical prostatectomy. The program combines tadalafil, pelvic floor training, aerobic exercise, nutrition guidance, and psychological support, delivered through a digital, self-directed format. Participants are randomized to receive the intervention in addition to standard care or standard care alone, with outcomes assessed after catheter removal and beyond. The study aims to see whether the integrated approach improves erectile function and urinary continence post-surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults aged ≥18 years undergoing elective robot-assisted radical prostatectomy (RARP) with curative intent for confirmed prostate cancer.
2. Consulting a urological surgeon with an appointment at participating sites at least 4 weeks prior to scheduled surgery.
3. Willingness to engage in prescribed self-directed interventions.
4. Expected to have 100% unilateral OR \>50% bilateral nerve sparing at prostatectomy

Exclusion Criteria:

1. Cognitive impairment such that they lack capacity to provide informed consent.
2. Currently taking intracavernosal injection therapy.
3. Severe or complete erectile dysfunction at baseline, defined as an IIEF-5 score ≤7 or self-reported absence of erectile function.
4. Prescribed nitrates or guanylate cyclase stimulators (e.g., riociguat) - pharmacological contraindication to PDE5 inhibitor use.
5. Impaired renal function (GFR \<50 mL/min and/or creatinine clearance \<30 mL/min).
6. Severe hepatic impairment or concurrent prescription of medications that inhibit CYP3A4.
7. Loss of vision in one eye due to non-arteritic anterior ischaemic optic neuropathy (NAION).
8. Myocardial infarction within the last 90 days.
9. Stroke within the last 6 months.
10. Unstable angina or angina occurring during sexual intercourse.
11. New York Heart Association (NYHA) Class II or greater heart failure in the last 6 months.
12. Uncontrolled arrhythmias, hypotension (\<90/50 mmHg), or uncontrolled hypertension.
13. Contraindications to participating in the prescribed exercise program.
14. No access to a device with internet connectivity.

Where it's running

• Royal Prince Alfred Hospital
  Sydney, New South Wales, Australia Recruiting
• Concord Repatriation General Hospital (CRGH)
  Sydney, New South Wales, Australia Recruiting
• Chris O'Brien Lifehouse
  Sydney, New South Wales, Australia Not yet recruiting

Study contacts

• Principal investigator: Daniel Steffens — Surgical Outcomes Research Centre (SOuRCe)
• Study coordinator: Nicholas Hirst
• Email: Nicholas.Hirst1@health.nsw.gov.au
• Phone: +61 2 9515 3200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.