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Completed

NCT Number: NCT02409212

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Sheffield Teaching Hospitals NHS Trust

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise Training

Behavioral

Aerobic exercise training will be undertaken for 12 months, combining supervised and independent exercise sessions. Behaviour change counselling will take place bi-monthly, either via face to face sessions during exercise or via telephone by study clinical exercise specialist according to participant preference.

Placebo surveillance and written exercise guidelines

Behavioral

Optimal active surveillance according to NICE guidelines and written exercise guidelines from Macmillan cancer

Primary outcomes

  1. 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.

Secondary outcomes

  1. Feasibility as measured by Intervention adherence

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Collaborators

  • Institute of Cancer Research, United Kingdom
  • Queen Mary University of London
  • Sheffield Hallam University
  • University College London Hospitals
  • University of Sheffield

Registry information

Official study title

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

Acronym: PANTERA

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 6, 2015
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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