NCT07576335RecruitingPhase 2
Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy
Multimodal Perioperative Optimisation for Patients Undergoing Robot-Assisted Radical Prostatectomy: A Randomised Controlled Trial Targeting Postoperative Erectile Dysfunction (ROBOPREP Trial)
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 22 Apr 2026
- Start date
- 31 Aug 2026
- Primary completion date
- 1 Dec 2028
- Lead sponsor
- Surgical Outcomes Research Centre (SOuRCe)
- Diseases
- Prostate cancer
- NCT number
- NCT07576335
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 64
- From 31 Aug 2026 to the primary completion date, 1 Dec 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking intracavernosal injection therapy.
- Prescribed nitrates or guanylate cyclase stimulators (e.g., riociguat) - pharmacological contraindication to PDE5 inhibitor use.
- Severe hepatic impairment or concurrent prescription of medications that inhibit CYP3A4.
Other illness
- Cognitive impairment such that they lack capacity to provide informed consent.
- 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.
Lab values
- Impaired renal function (GFR \<50 mL/min and/or creatinine clearance \<30 mL/min).
Other
- Severe or complete erectile dysfunction at baseline, defined as an IIEF-5 score ≤7 or self-reported absence of erectile function.
- Loss of vision in one eye due to non-arteritic anterior ischaemic optic neuropathy (NAION).
- Contraindications to participating in the prescribed exercise program.
- No access to a device with internet connectivity.
Who the study is looking for
- 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.
- Expected to have 100% unilateral OR \>50% bilateral nerve sparing at prostatectomy
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Prince Alfred Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Recruiting |
| Chris O'Brien Lifehouse Coordinator of this site? Confirm its status | Sydney | Australia | Not yet recruiting |
| Concord Repatriation General Hospital (CRGH) Coordinator of this site? Confirm its status | Sydney | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.