Rehabilitation program to prevent side effects in metastatic prostate cancer patients on hormone therapy
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 study is testing a special exercise program to see if it can help men with metastatic prostate cancer on hormone therapy feel better and avoid side effects like fatigue.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Azienda USL Reggio Emilia - IRCCS Government |
| Locations | 1 site (Reggio Emilia) |
| Trial ID | NCT06238596 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of a tailored exercise program for patients with metastatic prostate cancer undergoing androgen-deprivation therapy (ADT). It focuses on adherence to a 12-week multicomponent exercise regimen, which includes aerobic, resistance, balance, and flexibility training, supervised by a physiotherapist. The study also aims to assess recruitment and retention rates, monitor safety, and evaluate the program's effectiveness in reducing adverse events associated with ADT, such as fatigue and loss of physical performance.
Who should consider this trial
Good fit: Ideal candidates include men diagnosed with metastatic prostatic adenocarcinoma who are candidates for ADT and have an ECOG performance status of 0-1.
Not a fit: Patients with severe physical or psychological conditions that limit their ability to adhere to the exercise program may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life and physical well-being of patients undergoing ADT for metastatic prostate cancer.
How similar studies have performed: While similar rehabilitation interventions have shown promise in improving outcomes for cancer patients, this specific approach in metastatic prostate cancer is still being explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Reggio Emilia
- SOC Oncologia Medica Provinciale — Reggio Emilia, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.