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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Aerobic exercise training; Behavioral: Placebo surveillance and written exercise guidelines

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S10 2JF
      • Sheffield Teaching Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 12 months of aerobic exercise training with behaviour change support	Behavioral: Aerobic exercise training; 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 Comparator: Comparison; Optimal active surveillance according to NICE guidelines and written exercise guidelines from Macmillan cancer	Behavioral: Placebo surveillance and written exercise guidelines; Optimal active surveillance according to NICE guidelines and written exercise guidelines from Macmillan cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility as measured by rate of recruitment	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.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility as measured by Intervention adherence	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.	36 months

Collaborators and Investigators

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Collaborators: University College London Hospitals; University of Sheffield; Queen Mary University of London; Sheffield Hallam University; Institute of Cancer Research, United Kingdom
• Investigators: Principal Investigator: Derek Rosario, MD, University of Sheffield / Sheffield Teaching Hospitals

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: January 20, 2015
• First Submitted That Met QC Criteria: April 3, 2015
• First Posted (Estimate): April 6, 2015

Study Record Updates

• Last Update Posted (Actual): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: STH 18624