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

Prostate Cancer Clinical Trial

— PANTERA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02409212
• Other study ID #: STH 18624
• Status: Completed
• Phase: Phase 2
• Start date: May 2015
• Est. completion date: December 2018

Study information

• Verified date: January 2019
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Sheffield Teaching Hospitals NHS Trust	Sheffield	South Yorkshire

Sponsors (6)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust	Institute of Cancer Research, United Kingdom, Queen Mary University of London, Sheffield Hallam University, University College London Hospitals, University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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