Exercise Training as a Novel Primary Therapy for Men With Localised Prostat... | Not Recruiting
Exercise Training as a Novel Primar... | Not Recruiting
Exercise Training as a Novel Primary Therapy for Men With Localised Prostate Cancer
PANTERA

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Medical Conditions
  • Prostate Cancer
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT02409212
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
    Sorry, this information is not available
Phase
Phase 2
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Behavioral : Aerobic exercise training, Behavioral : Placebo surveillance and written exercise guidelines

Study Arm Groups : Intervention, Comparison

Intervention Type
See Interventions above
Primary Outcome Measures
    Feasibility as measured by rate of recruitment; 36 months
Secondary Outcome Measures
    Feasibility as measured by Intervention adherence; 36 months
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Male
Age Range
N/A - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
GSK Investigational Site
Sheffield
S10 2JF
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Exercise Training as a Novel Primary Therapy for Men With Localised Prostate Cancer: the PANTERA Trial (Prostate cAncer Novel ThERApy)
EudraCT Number
Not available for this trial
Funder(s)
  • Sheffield Hallam University
  • University of Sheffield
  • Queen Mary University of London
  • University College London Hospitals
  • Institute of Cancer Research, United Kingdom
Other Study ID Numbers
STH 18624
Sponsor(s)
Sheffield Teaching Hospitals NHS Foundation Trust
Key Dates

Recruitment Start Date

May 2015

Recruitment End Date

Dec 2017

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

20 Jan 2015

Date updated in source

16 Nov 2016