Prostate CancerNCT05553327
Impact of a Multimodal Prehabilitation Program Before Robotic-assisted Radical Prostatectomy.
A study testing Multimodal prehabilitation in people with Prostate Cancer and Radical Prostatectomy, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Prostate Cancer, Radical Prostatectomy
- What is being tested?
- Multimodal prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 31 May 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Multimodal Prehabilitation Program Before Robotic-assisted Radical Prostatectomy. A Randomized Clinical Trial.
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.
Read the detailed description
Single center randomized clinical trial including prostate cancer patients undergoing robotic-assisted radical prostatectomy at the Hospital Clínic 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.
- Conditions
- Prostate Cancer, Radical Prostatectomy
- Being tested
- Multimodal prehabilitation
- Keywords
- Prehabilitation, Robotic-assisted radical prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal prehabilitationBehavioural
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:
- Physical activity: aerobic/resistance exercises 45-60min x 2-3 times per week (adapted by a personal trainer), encouraged to walk 7500 steps daily
- 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
- Nutritional optimization: weekly group sessions led by a dietitian and supplementation was tailored to individuals needs.
- Psychological Support: weekly 60-minute group sessions based on mindfulness-based stress reduction led by a psychologist
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Multimodal prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From baseline to 1 month after RARP
Secondary outcomes (6)
Additional HRQoL domains of the EORTC QLQ-C30
Additional HRQoL domains of the EORTC QLQ-C30
Measured: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
Mental health
Hospital Anxiety and Depression Scale (HADS)
Measured: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
Physical performance
6-minute walk test (6MWT)
Measured: 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)
Measured: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
Erectile Function
Index of Erectile Function-5 (IIEF-5)
Measured: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
Disease-specific HRQoL
EORTC QLQ-PR25
Measured: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start31 May 2022
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoni Vilaseca, Dr, Principal investigator, Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553327
- Sponsor's protocol ID
- HCB/2021/0289
- Status last verified
- Feb 2026
- First submitted
- 15 Sep 2022
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Multimodal Prehabilitation Program Before Robotic-assisted Radical Prostatectomy. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05553327
- Acronym / sponsor ID
- HCB/2021/0289
- Conditions
- Prostate Cancer, Radical Prostatectomy
- Keywords
- Prehabilitation, Robotic-assisted radical prostatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Single center randomized clinical trial including prostate cancer patients undergoing robotic-assisted radical prostatectomy at the Hospital Clínic 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients receive standard preoperative instructions, including routine lifestyle counseling consistent with hospital practice. |
| Multimodal prehabilitation | Experimental | Behavioral: Multimodal prehabilitationThis patients receive the full pre-habilitation program |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal prehabilitationPatients 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 | Behavioural | Multimodal prehabilitation |
Primary outcome
Early postoperative HRQoL
Time frame: From baseline to 1 month after RARP
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)
6 secondary outcomes
Additional HRQoL domains of the EORTC QLQ-C30
Time frame: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
Mental health
Time frame: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
Physical performance
Time frame: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
Functional recovery
Time frame: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
Erectile Function
Time frame: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
Disease-specific HRQoL
Time frame: Baseline, post-prehabilitation (pre-surgery), and at 1, 3, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoni Vilaseca, Dr principal investigator
Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal prehabilitation in people with Prostate Cancer and Radical Prostatectomy, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early postoperative HRQoL (time frame: From baseline to 1 month after RARP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.