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

NHS Foundation Trust

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Behavioral: Placebo surveillance and written exercise guidelines

Behavioral: Aerobic exercise training

Study type

Interventional

Funder types

Other

Identifiers

NCT02409212

STH 18624

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

Male

Volunteers

No Healthy Volunteers

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