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) (ReCaP)

July 23, 2026 updated by: Azienda USL Reggio Emilia - IRCCS

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Italy
      • Reggio Emilia, Italy, Italy, 42123
        • SOC Oncologia Medica Provinciale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of prostatic adenocarcinoma;
  • Metastatic disease candidate to ADT treatment and ADT free;
  • ECOG PS 0-1.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rehabilitation + standard of care (SOC)
All enrolled patients will start a supervised rehabilitation program for 12 weeks
Procedure: rehabilitation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adherence
Time Frame: 12 weeks
Defined as percentage of patients who complete treatment schedule ≥ 75%
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recruitment rate
Time Frame: 12 weeks, 24 weeks, 12 months
percentage of patients who agree to adhere to the study
12 weeks, 24 weeks, 12 months
retention rates
Time Frame: 12 weeks, 24 weeks, 12 months
percentage of enrolled patients undergoing re-evaluation at these times
12 weeks, 24 weeks, 12 months
hand grip strength (HGS)
Time Frame: baseline, 12 weeks, 24 weeks, 12 months
dichotomized as <27 (low) and >=27Kg (normal)
baseline, 12 weeks, 24 weeks, 12 months
physical activity (PA)
Time Frame: baseline, 12 weeks, 24 weeks, 12 months
measured by International Physical Activity Questionnaire (IPAQ)
baseline, 12 weeks, 24 weeks, 12 months
physical performance
Time Frame: baseline, 12 weeks, 24 weeks, 12 months
measured by Short Physical Performance Battery (SPPB)
baseline, 12 weeks, 24 weeks, 12 months
fatigue
Time Frame: 12 weeks, 24 weeks, 12 months
measured by Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F)
12 weeks, 24 weeks, 12 months
Safety and Tolerability
Time Frame: baseline, 12 weeks, 24 weeks, 12 months
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;
baseline, 12 weeks, 24 weeks, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda USL Reggio Emilia - IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2023

Primary Completion (Actual)

March 3, 2025

Study Completion (Actual)

May 29, 2026

Study Registration Dates

First Submitted

January 25, 2024

First Submitted That Met QC Criteria

January 25, 2024

First Posted (Actual)

February 2, 2024

Study Record Updates

Last Update Posted (Actual)

July 24, 2026

Last Update Submitted That Met QC Criteria

July 23, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ReCaP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe