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)

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: Active, not recruiting
• Conditions: Rehabilitation; Metastatic Prostate Cancer (PCa) in ADT
• Intervention / Treatment: Procedure: rehabilitation

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	Defined as percentage of patients who complete treatment schedule ≥ 75%	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Azienda USL Reggio Emilia - IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2023
• Primary Completion (Actual): March 3, 2025
• Study Completion (Estimated): May 1, 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 (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Rehabilitation; feasibility; adverse events
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Aftercare; Continuity of Patient Care; Rehabilitation
• Other Study ID Numbers: RECAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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