Back to resultsExercise Training as a Novel Primary Therapy for Men With Localised Prostate Cancer (PANTERA)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Aerobic exercise training
Placebo surveillance and written exercise guidelines
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
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:
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
Sites / Locations
- Sheffield Teaching Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Comparison
Arm Description
12 months of aerobic exercise training with behaviour change support
Optimal active surveillance according to NICE guidelines and written exercise guidelines from Macmillan cancer
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02409212
First Posted
January 20, 2015
Last Updated
January 29, 2019
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
Sheffield Hallam University, University of Sheffield, Queen Mary University of London, University College London Hospitals, Institute of Cancer Research, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT02409212
Brief Title
Exercise Training as a Novel Primary Therapy for Men With Localised Prostate Cancer
Acronym
PANTERA
Official Title
Exercise Training as a Novel Primary Therapy for Men With Localised Prostate Cancer: the PANTERA Trial (Prostate cAncer Novel ThERApy)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
Sheffield Hallam University, University of Sheffield, Queen Mary University of London, University College London Hospitals, Institute of Cancer Research, United Kingdom
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
12 months of aerobic exercise training with behaviour change support
Arm Title
Comparison
Arm Type
Placebo Comparator
Arm Description
Optimal active surveillance according to NICE guidelines and written exercise guidelines from Macmillan cancer
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Placebo surveillance and written exercise guidelines
Intervention Description
Optimal active surveillance according to NICE guidelines and written exercise guidelines from Macmillan cancer
Primary Outcome Measure Information:
Title
Feasibility as measured by rate of recruitment
Description
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.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Feasibility as measured by Intervention adherence
Description
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.
Time Frame
36 months
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derek Rosario, MD
Organizational Affiliation
University of Sheffield / Sheffield Teaching Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheffield Teaching Hospitals NHS Trust
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Exercise Training as a Novel Primary Therapy for Men With Localised Prostate Cancer
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