Exercise Training as a Novel Primary Therapy for Men With Localised Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Behavioral: Placebo surveillance and written exercise guidelines; Behavioral: Aerobic exercise training

• Registration Number: NCT02409212
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

Study design: The study is a two arm randomised controlled trial (randomisation ratio 1:1) comparing an aerobic exercise training intervention to usual care plus exercise advice. The primary outcome is the feasibility of the intervention as novel primary therapy in men with localised prostate cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-20
• Study First Submitted QC: 2015-04-03
• Study First Posted: 2015-04-06
• Study Start: 2015-05
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

In accordance with NICE active surveillance guidelines, men:

• Who have been evaluated using a combination of clinical, bio-chemical, imaging and/or biopsy, within the last 12 months
• With histologically confirmed low or intermediate risk prostate cancer, Gleason score ≤7 (3+4, not 4+3)
• With up to T2a clinical stage tumours
• With pre-treatment PSA ≤20 ng/mL
• Who are willing to participate in optimal active surveillance and provide written informed consent
• With life expectancy of ≥10 years

Exclusion Criteria

Men:

• With unstable angina
• With uncontrolled hypertension
• With recent myocardial infarction (within the past 6 months)
• With pacemakers
• Already undertaking regular physical activity (greater than 90 minutes of moderate intensity exercise, per week) will be excluded
• With any other physical or mental limitation preventing participation in trial assessments
• Participating in other clinical trials which might bias the evaluation of the primary objectives of the present study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparison	Placebo surveillance and written exercise guidelines	Optimal active surveillance according to NICE guidelines and written exercise guidelines from Macmillan cancer
Intervention	Aerobic exercise training	12 months of aerobic exercise training with behaviour change support

Primary Outcome Measures

Name	Time	Method
Feasibility as measured by rate of recruitment	36 months	The rate of recruitment will be measured by comparing the number of patients screended to the number of patients recruited. This will allow us to asses if a future full-scale trial is feasible.

Secondary Outcome Measures

Name	Time	Method
Feasibility as measured by Intervention adherence	36 months	Intervention adherence will be assessed using an exercise log book and heart rate monitor to objectively record independent exercise behaviour and support adherence and compliance.

Trial Locations

Locations (1)

Sheffield Teaching Hospitals NHS Trust; 🇬🇧 Sheffield, South Yorkshire, United Kingdom