NCT05553327

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

April 1, 2026

Status Verified

February 1, 2026

Enrollment Period

2.3 years

First QC Date

September 15, 2022

Last Update Submit

March 26, 2026

Conditions

Prostate CancerRadical Prostatectomy

Keywords

PrehabilitationRobotic-assisted radical prostatectomy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Additional HRQoL domains of the EORTC QLQ-C30

    Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months

  • Mental health

    Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months

  • Physical performance

    Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months

  • Functional recovery

    Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months

  • Erectile Function

    Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months

  • +1 more secondary outcomes

Study Arms (2)

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

Behavioral: Multimodal prehabilitation

Interventions

Multimodal prehabilitationBEHAVIORAL

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: 1. Physical activity: aerobic/resistance exercises 45-60min x 2-3 times per week (adapted by a personal trainer), encouraged to walk 7500 steps daily 2. Pelvic floor muscle training: a structured PFMT program, introduced and supervised by a physiotherapist during baseline assessment and unsupervised with written instructions for home practice 3. Nutritional optimization: weekly group sessions led by a dietitian and supplementation was tailored to individuals needs. 4. Psychological Support: weekly 60-minute group sessions based on mindfulness-based stress reduction led by a psychologist

Multimodal prehabilitation

Eligibility Criteria

Age18 Years - 99 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsHistologically confirmed localized or locally advanced prostate cancer scheduled for robotic-assisted radical prostatectomy (RARP)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Metastatic disease
  • Prior treatment for prostate cancer (e.g., brachytherapy, radiotherapy), - Significant cardiopulmonary comorbidities contraindicating physical activity
  • Declining consent
  • Patients referred from hospitals outside our city were also excluded (to ensure consistent adherence to the prehabilitation program at nearby fitness centers).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, Catalonia, 08036, Spain

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Antoni Vilaseca, Dr

    Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2022

First Posted

September 23, 2022

Study Start

May 31, 2022

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

April 1, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)