SUPERvised Three-month Exercise Program in MEN With Prostate cAncer Receiving Androgen-deprivaTioN thERapy (Superman)

The goal of this single blind placebo-controlled intervention study is to examine the impact of a supervised training program on disease-related quality of life and physical fitness in patient with advanced prostate cancer compared to usual care. The main question[s] it aims to answer are:

• What is the impact of exercise on quality of life
• What is the impact of exercise on physical fitness

Participants will have an individual training program with supervised training by physiotherapists.

Researchers will compare with usual care to see if advice about exercise has significant less effect than an supervised training program.

Study Overview

• Status: Not yet recruiting
• Conditions: Prostatic Neoplasms; Metastasis
• Intervention / Treatment: Other: Physiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: stijn Elbers, MD; Phone Number: (+31)243657657; Email: s.elbers@cwz.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Signed informed consent
• Age > 18 years old
• Able to read and complete questionnaires in Dutch
• Proven histologically and /or radiologically metastatic prostate cancer (TxNxM1)

Exclusion Criteria:

• Other cancers
• Clinicians' judgement
• Age >80 years old or not able to walk 400m
• Structural exercise (moderate-intensity exercise more than 150 minutes a week) during the past 3 months
• Musculoskeletal, cardiovascular, or neurological disorders that could inhibit them from exercising
• Spinal cord compression, history of pathological fractures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention; supervised training program for twelve weeks + usual care + advice about exercise	Other: Physiotherapy; supervised training program for twelve weeks + usual care + advice about exercise
No Intervention: usual care; usual care + advice about exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of quality of life assessed with EPIC26 (0-100 points)	To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaire is used: Expanded Prostate Cancer Index Composite (EPIC26). With higher scores representing better disease-related quality of life.	6 months
change of quality of life assessed with EPIC26 (0-100 points)	To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaire is used: Expanded Prostate Cancer Index Composite (EPIC26). With higher scores representing better disease-related quality of life.	3 months
change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale)	To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaires are used: European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC QLQ-C30). A higher score represents a higher response level. So a higher score for the functional scale represents a higher level of physical functioning but a higher score for the symptoms scale represents a higher level of symptoms.	6 months
change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale)	To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaires are used: European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC QLQ-C30). A higher score represents a higher response level. So a higher score for the functional scale represents a higher level of physical functioning but a higher score for the symptoms scale represents a higher level of symptoms.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of physical fitness in maximum uptake of oxygen in ml/kg/min	Assessment of the effectiveness of a supervised training program on cardiopulmonary fitness in patients with metastatic prostate cancer compared to usual care.	6 months
change of physical fitness in maximum uptake of oxygen in ml/kg/min	Assessment of the effectiveness of a supervised training program on cardiopulmonary fitness and body composition in patients with metastatic prostate cancer compared to usual care.	3 months
change of physical fitness in fat percentage	change in body composition in patients with metastatic prostate cancer compared to usual care.	3 months
change of physical fitness in fat percentage	change in body composition in patients with metastatic prostate cancer compared to usual care.	6 months
change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes))	To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaires are used: Short Hebrew International Physical Activity Questionnaire (IPAQ-sh). Both categorical and continuous indicators of physical activity will be used from the IPAQ short form. There are three categories:1. inactive, 2. minimally active, 3. HEPA active (health enhancing physical activity; a high active category). The continuous score is reported in median MET-minutes (metabolic equivalent of task-minutes). For categorical and continuous score is a higher score equivalent of higher physical functioning.	3 months
change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes))	To examine the impact of a supervised training program on disease-related quality of life in patient with advanced prostate cancer compared to usual care. The following questionnaires are used: Short Hebrew International Physical Activity Questionnaire (IPAQ-sh). Both categorical and continuous indicators of physical activity will be used from the IPAQ short form. There are three categories:1. inactive, 2. minimally active, 3. HEPA active (health enhancing physical activity; a high active category). The continuous score is reported in median MET-minutes (metabolic equivalent of task-minutes). For categorical and continuous score is a higher score equivalent of higher physical functioning.	6 months

Collaborators and Investigators

• Sponsor: Canisius-Wilhelmina Hospital
• Investigators: Principal Investigator: Jean-Paul van Basten, Dr. MD, Canisius Wilhelmina Ziekenhuis (CWZ)

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CanisiusWH

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