Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy

Starting soon · Phase 2

Conditions studied: Erectile Dysfunction Following Radical Prostatectomy, Prostate Cancer, Urinary Incontinence Following Surgical Procedure

In brief

Prostate cancer is the most common cancer in Australian men. Robot-assisted radical prostatectomy (RARP) - surgical removal of the prostate - is a standard treatment, but it frequently causes erectile dysfunction (ED) and urinary incontinence that can persist for years and significantly affect quality of life. This trial (ROBOPREP) will test whether a multimodal program of prehabilitation (before surgery) and rehabilitation (after surgery) improves erectile function and urinary continence in men undergoing RARP, compared to standard care alone. The program includes four components, all delivered virtually and in a self-directed manner: 1. Pharmacological - tadalafil 5 mg once daily (a low-dose, TGA-approved erectile medication) beginning 4 weeks before surgery, paused during hospital admission, and resumed for 3 months following catheter removal after surgery. 2. Exercise - pelvic floor muscle training (3 sets per day) and aerobic exercise (40 minutes, 4 times per week) to strengthen the muscles and vascular supply involved in erectile and urinary function. 3. Nutrition - dietary guidance to support surgical recovery and vascular health. 4. Psychological/wellbeing - relaxation techniques, psychoeducation about expected recovery, and self-compassion strategies to address cancer-related anxiety. A total of 64 men will be recruited across three major Sydney hospitals (Royal Prince Alfred Hospital, Concord Repatriation General Hospital, and Chris O'Brien Lifehouse) and randomly assigned 1:1 to the multimodal program plus standard care, or to standard care alone. Outcomes - including erectile function (primary), urinary continence, quality of life, and psychological wellbeing - are assessed at baseline and at 6 weeks, 3, 6, and 12 months following surgery. All participant-facing elements of the program are digital, low-cost, and designed for real-world scalability.

Key facts

Study ID

NCT07576335

Run by

Surgical Outcomes Research Centre (SOuRCe)

People needed

64

Starts

2026-05-01

Expected to finish

2028-11-01

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged ≥18 years undergoing elective robot-assisted radical prostatectomy (RARP) with curative intent for confirmed prostate cancer.
• Consulting a urological surgeon with an appointment at participating sites at least 4 weeks prior to scheduled surgery.
• Willingness to engage in prescribed self-directed interventions.

You may not qualify if…

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

Where it is running

• Chris O'Brien Lifehouse — Sydney, New South Wales, Australia
• Royal Prince Alfred Hospital — Sydney, New South Wales, Australia
• Concord Repatriation General Hospital (CRGH) — Sydney, New South Wales, Australia

Full record on ClinicalTrials.gov

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