Clinical trial · Interventional
Prehabilitation for Prostate Cancer Surgery
A Multicentre, Pilot Randomized Controlled Trial to Examine the Effects of Prehabilitation on Functional Outcomes After Radical Prostatectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Radical prostatectomy is the most common and effective treatment for localized prostate cancer. Unfortunately, radical prostatectomy is associated with significant adverse effects, such as urinary incontinence, sexual dysfunction, and reduced physical function that collectively diminish health-related quality of life which may persist for up to two years postoperatively. The primary objective of this trial is to assess the feasibility of conducting of a multi-site randomized controlled trial to test the effect of a comprehensive prehabilitation program versus standard care for men with prostate cancer undergoing radical prostatectomy. We hypothesize that men with prostate cancer undergoing radical prostatectomy in the comprehensive prehabilitation program (full-body exercises and pelvic floor muscle exercises) will report better health-related quality of life, urological symptoms, and physical fitness, physical activity, and pain, as well as a shorter postoperative length of stay than participants receiving standard preoperative care (pelvic floor muscle exercises alone). Our secondary objective is to report estimates of efficacy on several clinically important outcomes for this population that will be used for sample size calculations in an adequately powered trial.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer Patients Undergoing Radical Prostatectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prehabilitation (PREHAB) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Healthy Lifestyle Booklet
- description
- Standard care for radical prostatectomy (RP) patients includes the provision of preoperative information from a urology nurse educator. Usual care (UC) participants will be given generic instructions by the research coordinator about pelvic floor muscle exercises (PFMX), mobilization and general timeframes for a return to normal activities. The UC group will receive the same PFMX prescription as the PREHAB (Experimental) group and will receive weekly communication from the research coordinator regarding compliance with the PFMX prescription to provide an attentional-control. These instructions are provided in a healthy lifestyle booklet for men with prostate cancer.
- type
- EXPERIMENTAL
- label
- Prehabilitation (PREHAB)
- description
- The prehabilitation (PREHAB) program focuses on total-body physical exercises and pelvic floor muscle exercises (PFMX). The total-body exercise prescription will consist of 60 minutes of home-based, unsupervised exercise on 3-4 days per week, alternating between aerobic and resistance training. Each session will include: a 5-minute warm-up, 25 minutes of aerobic exercise, 25 minutes of resistance training (5 exercises targeting major muscle groups), and a 5-minute cool-down. Training intensity progression will occur throughout the intervention. Participants will be provided with resistance bands, a stability ball, and an exercise mat. The PFMX prescription will include a gradual increase in PFMX exercises from 60 per day during weeks 1-2, 120 per day during weeks 3-4, and 180 per day during weeks 5-6 until the surgery date. The total number of repetitions of the PFMXs will be divided equally between the rhythmic and sustained contractions.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Men with localized prostate cancer (stage cT1- cT2) who have consented for radical prostatectomy * between the ages of 40 and 80 years. Exclusion Criteria: * i) severe coronary artery disease (Canadian Cardiovascular Society class III or greater); * ii) significant congestive heart failure (New York Heart Association class III or greater); * iii) uncontrolled pain; * iv) neurological or musculoskeletal co-morbidity inhibiting exercise; * v) diagnosed psychotic, addictive, or major cognitive disorders; * vi) no more than two of the following Coronary Risk Factors as defined by the American College of Sports Medicine : family history of coronary disease, cigarette smoking, hypertension (SBP \> 140 mmHg; DBP \> 90 mmHg), known dyslipidemia, known impaired fasting, glucose (\>110 mg/dL), obesity (BMI \> 30 kg/m2 or waist circumference \> 102cm), or physically inactive (\<150 min of moderate intensity physical activity per week).
References
Publications (2)
- DERIVEDAu D, Matthew AG, Lopez P, Hilton WJ, Awasthi R, Bousquet-Dion G, Ladha K, Carli F, Santa Mina D. Prehabilitation and acute postoperative physical activity in patients undergoing radical prostatectomy: a secondary analysis from an RCT. Sports Med Open. 2019 May 22;5(1):18. doi: 10.1186/s40798-019-0191-2. PMID 31119491
- DERIVEDSanta Mina D, Matthew AG, Hilton WJ, Au D, Awasthi R, Alibhai SM, Clarke H, Ritvo P, Trachtenberg J, Fleshner NE, Finelli A, Wijeysundera D, Aprikian A, Tanguay S, Carli F. Prehabilitation for men undergoing radical prostatectomy: a multi-centre, pilot randomized controlled trial. BMC Surg. 2014 Nov 13;14:89. doi: 10.1186/1471-2482-14-89. PMID 25394949