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The aim of the study is to verify whether a multimodal prehabilitation program prior to robotic-assisted radical prostatectomy (RARC) contributes to a faster recovery of quality of life after surgery.
Single center randomized clinical trial including prostate cancer patients undergoing robotic-assisted radical prostatectomy at the Hospital ClÃnic de Barcelona. Patients will be randomized into two groups, one receiving multimodal prehabilitation and the other a control group. Multimodal prehabilitation consists of improving the functional and mental capacity of an individual to cope with a significant stressor, in this case surgery. The design of our prehabilitation program, lasting 4 weeks prior to surgery, consists of three parts; physical state, nutritional state and mental health. In the case of physical condition, a series of supervised and "home-based" exercises (aerobic and functional) will be carried out in addition to specific pelvic floor exercises. The nutritional status will be evaluated by a nutritionist. Diet guidelines will be given and if there are deficiencies they will be supplemented. Regarding mental health, a visit will be made with a psychologist and group and online therapies will be offered. The outcomes will be evaluated before starting the prehabilitation program, at the end of it (just before surgery) and at 4, 8 and 16 weeks after surgery. The outcomes include variables on physical, nutritional and mental state, health-related quality of life (HRQoL), and continence and erectile function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Patients receive standard preoperative instructions, including routine lifestyle counseling consistent with hospital practice. | |
| Multimodal prehabilitation | Experimental | This patients receive the full pre-habilitation program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal prehabilitation | Behavioral | Patients randomized to the intervention group participated in a structured, four-week multimodal prehabilitation program, initiated immediately after the baseline assessment. The program was delivered by a multidisciplinary prehabilitation team. The program consisted of the following components lead by specialists:
|
| Measure | Description | Time Frame |
|---|---|---|
| Early postoperative HRQoL | The change in the global health status domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | From baseline to 1 month after RARP |
| Measure | Description | Time Frame |
|---|---|---|
| Additional HRQoL domains of the EORTC QLQ-C30 | Additional HRQoL domains of the EORTC QLQ-C30 | Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months |
| Mental health | Hospital Anxiety and Depression Scale (HADS) |
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Eligible patients:
Exclusion criteria:
Histologically confirmed localized or locally advanced prostate cancer scheduled for robotic-assisted radical prostatectomy (RARP)
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| Name | Affiliation | Role |
|---|---|---|
| Antoni Vilaseca, Dr | Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic de Barcelona | Barcelona | Catalonia | 08036 | Spain |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 19, 2026 | Feb 23, 2026 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months |
| Physical performance | 6-minute walk test (6MWT) | Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months |
| Functional recovery | Urinary continence using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) | Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months |
| Erectile Function | Index of Erectile Function-5 (IIEF-5) | Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months |
| Disease-specific HRQoL | EORTC QLQ-PR25 | Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |