Metastatic Prostate Cancer (PCa) in ADTReCaPNCT06238596
Rehabilitation Intervention to Prevent Adverse Events Related to Androgen-deprivation Therapy (ADT) in Patients With Metastatic Prostate Cancer (PCa): a Single Arm Feasibility Study (ReCaP Study)
A study testing rehabilitation in people with Metastatic Prostate Cancer (PCa) in ADT and Rehabilitation, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial summary
This is a drug-free, single arm, single center, superiority, interventional study aimed at treatment feasibility. The main aim of the current study is to assess feasibility of a tailored exercise program as measured by adherence to exercise program in metastatic PCa patients undergoing ADT. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Cancer (PCa) in ADT, Rehabilitation
- What is being tested?
- rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 6 Sep 2023to 29 May 2026
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of prostatic adenocarcinoma;
- Metastatic disease candidate to ADT treatment and ADT free;
- ECOG PS 0-1.
Who cannot join
- Physical conditions that may limit adherence to the study (heart failure NYHA 3-4, pathologic fractures, previous disability limiting exercise, etc);
- Psychological/psychiatric conditions that may limit adherence to the study (moderate-severe cognitive impairment, psychiatric disorders, etc.)
- Other concomitant active malignancies
Trial locations and contacts
1 site in 1 country.
About this study
This is a drug-free, single arm, single center, superiority, interventional study aimed at treatment feasibility.
The main aim of the current study is to assess feasibility of a tailored exercise program as measured by adherence to exercise program in metastatic PCa patients undergoing ADT.
Read more
Secondary aims are: to deepen the knowledge on other feasibility aspects (recruitment/retention), to monitor safety, to assess the effects in reducing the AEs of ADT (on loss of strength, loss of physical performance and fatigue, number of accidental falls and fractures), to monitor pain and the change in physical activity habits.
The rehabilitation intervention will be led by a Physiotherapist and will include: a 12 weeks standardized multicomponent exercise (aerobic, resistance, balance and flexibility, and impact exercise if indicated), supervised by the physiotherapist, on an outpatient basis or in telerehabilitation. This program will be adapted to single patient needs. Every exercise session will last almost 60 minutes and patients will be supervised twice a week. One more exercise session per week will be self-managed by patients.
At baseline a physiatrist will visit patients with bone metastasis and collect data on sites of bone metastasis, associated level of pain, and risk of pathological fractures. For all participants, the physiotherapist will assess muscle strength (Hand Grip Strength-HGS), physical performance (Short Physical Performance Battery-SPPB), level of fatigue (FACIT-F), and data collection on physical activity habits (International Physical Activity Questionnaire-IPAQ).
The enrollment will be closed after 1 year from the activation of the study or when the target of patients will be reached, whichever occurs firstly.
For each patient, data will be collected for 12 months. The duration of the study is expected to be around 2 years.
Follow-ups are scheduled at 12 weeks, 24 weeks and 12 months.
- Being tested
- rehabilitation
- Keywords
- Rehabilitation, feasibility, adverse events
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitationProcedure or surgery
The rehabilitation intervention will be led by a Physiotherapist and will include: a 12 weeks standardized multicomponent exercise (aerobic, resistance, balance and flexibility, and impact exercise if indicated), supervised by the physiotherapist, on an outpatient basis or in telerehabilitation. This program will be adapted to single patient needs. Every exercise session will last almost 60 minutes and patients will be supervised twice a week. One more exercise session per week will be self-managed by patients.
| Study group | Role | What they receive |
|---|---|---|
| rehabilitation + standard of care (SOC) | Experimental | All enrolled patients will start a supervised rehabilitation program for 12 weeks Receives: Procedure: rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
adherence
Defined as percentage of patients who complete treatment schedule ≥ 75%
Measured: 12 weeks
Secondary outcomes (7)
recruitment rate
percentage of patients who agree to adhere to the study
Measured: 12 weeks, 24 weeks, 12 months
retention rates
percentage of enrolled patients undergoing re-evaluation at these times
Measured: 12 weeks, 24 weeks, 12 months
Safety and Tolerability
monitoring of accidental falls, traumatic and pathologic fractures occurred during the study course, and pain in the sites of bone metastasis (measured with NRS Scale); we will distinguish between AEs related to exercise program (pain or falls or fractures occurred during exercise sessions) from AEs not related to exercise;
Measured: baseline, 12 weeks, 24 weeks, 12 months
hand grip strength (HGS)
dichotomized as <27 (low) and >=27Kg (normal)
Measured: baseline, 12 weeks, 24 weeks, 12 months
physical activity (PA)
measured by International Physical Activity Questionnaire (IPAQ)
Measured: baseline, 12 weeks, 24 weeks, 12 months
physical performance
measured by Short Physical Performance Battery (SPPB)
Measured: baseline, 12 weeks, 24 weeks, 12 months
fatigue
measured by Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F)
Measured: 12 weeks, 24 weeks, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start6 Sep 2023
- Primary completion3 Mar 2025
- Study completion29 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate Cancer (PCa) in ADTStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a drug-free, single arm, single center, superiority, interventional study aimed at treatment feasibility.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238596
- Sponsor's protocol ID
- ReCaP
- Acronym
- ReCaP
- Status last verified
- Jul 2026
- First submitted
- 25 Jan 2024
- Last updated
- 24 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Intervention to Prevent Adverse Events Related to Androgen-deprivation Therapy (ADT) in Patients With Metastatic Prostate Cancer (PCa): a Single Arm Feasibility Study (ReCaP Study)
- ClinicalTrials.gov ID
- NCT06238596
- Acronym / sponsor ID
- ReCaP / ReCaP
- Keywords
- Rehabilitation, feasibility, adverse events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 29 May 2026 (actual)
- First posted
- 2 Feb 2024 (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.
This is a drug-free, single arm, single center, superiority, interventional study aimed at treatment feasibility.
The main aim of the current study is to assess feasibility of a tailored exercise program as measured by adherence to exercise program in metastatic PCa patients undergoing ADT.
Secondary aims are: to deepen the knowledge on other feasibility aspects (recruitment/retention), to monitor safety, to assess the effects in reducing the AEs of ADT (on loss of strength, loss of physical performance and fatigue, number of accidental falls and fractures), to monitor pain and the change in physical activity habits.
The rehabilitation intervention will be led by a Physiotherapist and will include: a 12 weeks standardized multicomponent exercise (aerobic, resistance, balance and flexibility, and impact exercise if indicated), supervised by the physiotherapist, on an outpatient basis or in telerehabilitation. This program will be adapted to single patient needs. Every exercise session will last almost 60 minutes and patients will be supervised twice a week. One more exercise session per week will be self-managed by patients.
At baseline a physiatrist will visit patients with bone metastasis and collect data on sites of bone metastasis, associated level of pain, and risk of pathological fractures. For all participants, the physiotherapist will assess muscle strength (Hand Grip Strength-HGS), physical performance (Short Physical Performance Battery-SPPB), level of fatigue (FACIT-F), and data collection on physical activity habits (International Physical Activity Questionnaire-IPAQ).
The enrollment will be closed after 1 year from the activation of the study or when the target of patients will be reached, whichever occurs firstly.
For each patient, data will be collected for 12 months. The duration of the study is expected to be around 2 years.
Follow-ups are scheduled at 12 weeks, 24 weeks and 12 months.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a drug-free, single arm, single center, superiority, interventional study aimed at treatment feasibility.
| Arm | Type | Receives |
|---|---|---|
| rehabilitation + standard of care (SOC) | Experimental | Procedure: rehabilitationAll enrolled patients will start a supervised rehabilitation program for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of prostatic adenocarcinoma;
- Metastatic disease candidate to ADT treatment and ADT free;
- ECOG PS 0-1.
Key exclusion criteria (3 listed)
- Physical conditions that may limit adherence to the study (heart failure NYHA 3-4, pathologic fractures, previous disability limiting exercise, etc);
- Psychological/psychiatric conditions that may limit adherence to the study (moderate-severe cognitive impairment, psychiatric disorders, etc.)
- Other concomitant active malignancies
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 |
|---|---|---|
| rehabilitationThe rehabilitation intervention will be led by a Physiotherapist and will include: a 12 weeks standardized multicomponent exercise (aerobic, resistance, balance and flexibility, and impact exercise if indicated), supervised by the physiotherapist, on an outpatient basis or in telerehabilitation. This program will be adapted to single patient needs. Every exercise session will last almost 60 minutes and patients will be supervised twice a week. One more exercise session per week will be self-managed by patients. | Procedure or surgery | rehabilitation + standard of care (SOC) |
Primary outcome
adherence
Time frame: 12 weeks
Defined as percentage of patients who complete treatment schedule ≥ 75%
7 secondary outcomes
recruitment rate
Time frame: 12 weeks, 24 weeks, 12 months
retention rates
Time frame: 12 weeks, 24 weeks, 12 months
Safety and Tolerability
Time frame: baseline, 12 weeks, 24 weeks, 12 months
hand grip strength (HGS)
Time frame: baseline, 12 weeks, 24 weeks, 12 months
physical activity (PA)
Time frame: baseline, 12 weeks, 24 weeks, 12 months
physical performance
Time frame: baseline, 12 weeks, 24 weeks, 12 months
fatigue
Time frame: 12 weeks, 24 weeks, 12 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 24 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rehabilitation in people with Metastatic Prostate Cancer (PCa) in ADT and Rehabilitation, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
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 3 inclusion and 3 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 24 Jul 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 Italy. 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?
adherence (time frame: 12 weeks). 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 24 Jul 2026.