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)

NCT06238596 | Active Not Recruiting

• 1 other identifier: ReCaP
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Metastatic Prostate Cancer (PCa) in ADT; Rehabilitation

Keywords

Rehabilitation; feasibility; adverse events

Outcome Measures

Primary Outcomes (1)

• adherence

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

  12 weeks

Secondary Outcomes (7)

• recruitment rate

  12 weeks, 24 weeks, 12 months

• retention rates

  12 weeks, 24 weeks, 12 months

• Safety and Tolerability

  baseline, 12 weeks, 24 weeks, 12 months

• hand grip strength (HGS)

  baseline, 12 weeks, 24 weeks, 12 months

• physical activity (PA)

  baseline, 12 weeks, 24 weeks, 12 months

Study Arms (1)

rehabilitation + standard of care (SOC)

EXPERIMENTAL

All enrolled patients will start a supervised rehabilitation program for 12 weeks

Procedure: rehabilitation

Interventions

rehabilitation PROCEDURE

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.

rehabilitation + standard of care (SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

SOC Oncologia Medica Provinciale

Reggio Emilia, Italy, 42123, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is a drug-free, single arm, single center, superiority, interventional study aimed at treatment feasibility.

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 2, 2024
• Study Start: September 6, 2023
• Primary Completion: March 3, 2025
• Study Completion: May 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)