Exercise Training as a Novel Primary Therapy for Men With Localised Prostate Cancer: the PANTERA Trial (Prostate cAncer Novel ThERApy)

Sheffield Teaching Hospitals NHS Foundation Trust1 site in 1 country50 target enrollmentMay 2015

ConditionsProstate Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Enrollment: 50
Locations: 1
Primary Endpoint: Feasibility as measured by rate of recruitment
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2015

End Date

December 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Responsible Party

Sponsor

Eligibility Criteria

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

•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

Outcomes

Primary Outcomes

Feasibility as measured by rate of recruitment

Time Frame: 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.