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Completed

NCT Number: NCT06238596

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)

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.

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Key information

Conditions

Metastatic Prostate Cancer (PCa) in ADT Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Rehabilitation Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

SOC Oncologia Medica Provinciale

Reggio Emilia, Italy, 42123

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. adherence

    Time frame: 12 weeks

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

Secondary outcomes

  1. recruitment rate

    Time frame: 12 weeks, 24 weeks, 12 months

    percentage of patients who agree to adhere to the study

  2. retention rates

    Time frame: 12 weeks, 24 weeks, 12 months

    percentage of enrolled patients undergoing re-evaluation at these times

  3. 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;

  4. hand grip strength (HGS)

    Time frame: baseline, 12 weeks, 24 weeks, 12 months

    dichotomized as <27 (low) and >=27Kg (normal)

  5. physical activity (PA)

    Time frame: baseline, 12 weeks, 24 weeks, 12 months

    measured by International Physical Activity Questionnaire (IPAQ)

  6. physical performance

    Time frame: baseline, 12 weeks, 24 weeks, 12 months

    measured by Short Physical Performance Battery (SPPB)

  7. fatigue

    Time frame: 12 weeks, 24 weeks, 12 months

    measured by Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F)

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Registry information

Acronym: ReCaP

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 2, 2024
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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