Exercise training for men with prostate cancer on hormone therapy

Not Applicable

• Conditions: Prostate cancer; Cancer; Malignant neoplasms of male genital organs

• Registration Number: ISRCTN46385239
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38610058/ (added 15/04/2024) 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/39223607/ Process evaluation workshop data (added 03/09/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-30
• Last Update Posted: 9 September 2024
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 697

Inclusion Criteria

1. Men with prostate cancer on ADT or due to start ADT within the next twelve weeks
2. Willing and able to provide informed consent

Exclusion Criteria

Current exclusion criteria as of 06/10/2021:
1. Absolute contraindication to exercise as defined by clinical guidance e.g. ACPICR standards
2. Uncontrolled hypertension
3. Uncontrolled diabetes mellitus
4. Recent myocardial infarction (within past 6 months)
5. Unable to provide informed consent (e.g. lack of capacity)
6. Unstable bony metastases unresponsive to treatment
7. Unable to complete study assessments
8. Participation in other lifestyle intervention trial for PCa
9. Estimated life expectancy of less than 12 months for reasons unrelated to PCa diagnosis
10. Involvement in previous STAMINA work packages or PPI panel

Previous exclusion criteria:
1. Proven metastatic castrate-resistant prostate cancer (mCRPC) on imaging
2. Unstable angina
3. Uncontrolled hypertension and/or diabetes mellitus
4. Recent myocardial infarction (within past 6 months)
5. Unable to provide informed consent (e.g. lacking capacity)
6. Painful or unstable bony metastases
7. Inability to read or speak English to an appropriate level is an exclusion criteria, to ensure safe compliance with the exercise programme
8. Fixed output pacemakers
9. Any other absolute contraindication to exercise as defined by clinical guidance, e.g. ACPICR standards
10. Unable to complete study assessments
11. Participation in other lifestyle intervention trials for PCa
12. Estimated life expectancy of less than 12 months for reasons unrelated to PCa diagnosis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Disease-specific quality of life at 12 months post registration measured by the Functional Assessment of Cancer Therapy – Prostate (FACT-P)<br>2. Fatigue at 12 months post registration measured by the Functional Assessment of Cancer Therapy - Fatigue (FACT-F)

Secondary Outcome Measures

Name	Time	Method
1. Physical, social, emotional and function wellbeing is measured using FACT-P at 3, 6 and 12 months post-registration<br>2. Cancer specific fatigue is measured using FACT-F at 3, 6 and 12 months post-registration<br>3. Leisure time physical activity measured using Godin Questionnaire at 3, 6 and 12 months<br>4. Fear of Cancer Recurrence is measured using FCR4 and FCR7 at 3, 6 and 12 months<br>5. Functional capacity and body composition is measured using blood pressure, chair sit-to-stand, waist and hip circumference and body mass at 3, 6 and 12 months<br>6. Adverse event rates and their severity are measured using a Safety Case Report Form<br>7. Cost-effectiveness is assessed using incremental cost-effectiveness ratios (ICERs)<br>8. Quality-adjusted life year (QALYs) is derived from the EQ-5D-5L at 3, 6, 12 and 24 months