Prostate CancerPhase 2PANTERANCT02409212
Exercise Training as a Novel Primary Therapy for Men With Localised Prostate Cancer
A Phase 2 study testing Aerobic exercise training in people with Prostate Cancer, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Aerobic exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2015to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Trust
Sheffield, South Yorkshire, S10 2JF
About this study
Official title: 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.
- Conditions
- Prostate Cancer
- Being tested
- Aerobic exercise training, Placebo surveillance and written exercise guidelines
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise trainingBehavioural
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 guidelinesBehavioural
Optimal active surveillance according to NICE guidelines and written exercise guidelines from Macmillan cancer
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 12 months of aerobic exercise training with behaviour change support Receives: Behavioral: Aerobic exercise training |
| Comparison | Placebo comparator | Optimal active surveillance according to NICE guidelines and written exercise guidelines from Macmillan cancer Receives: Behavioral: Placebo surveillance and written exercise guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (1)
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Hallam University, University of Sheffield, Queen Mary University of London, University College London Hospitals, Institute of Cancer Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Derek Rosario, MD, Principal investigator, University of Sheffield / Sheffield Teaching Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409212
- Sponsor's protocol ID
- STH 18624
- Acronym
- PANTERA
- Status last verified
- Jan 2019
- First submitted
- 20 Jan 2015
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training as a Novel Primary Therapy for Men With Localised Prostate Cancer: the PANTERA Trial (Prostate cAncer Novel ThERApy)
- ClinicalTrials.gov ID
- NCT02409212
- Acronym / sponsor ID
- PANTERA / STH 18624
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Sheffield Hallam University, University of Sheffield, Queen Mary University of London, University College London Hospitals, Institute of Cancer Research, United Kingdom
- Study start
- May 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 6 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Aerobic exercise training12 months of aerobic exercise training with behaviour change support |
| Comparison | Placebo comparator | Behavioral: Placebo surveillance and written exercise guidelinesOptimal active surveillance according to NICE guidelines and written exercise guidelines from Macmillan cancer |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise trainingAerobic 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. | Behavioural | Intervention |
| Placebo surveillance and written exercise guidelinesOptimal active surveillance according to NICE guidelines and written exercise guidelines from Macmillan cancer | Behavioural | Comparison |
Primary outcome
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.
1 secondary outcome
Feasibility as measured by Intervention adherence
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
Related trials for Prostate Cancer
Active, not recruitingPhase 2
Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer
PSA Level Greater Than Two, Stage IV Prostate Adenocarcinoma AJCC v7
RecruitingEarly Phase 1
FTT PET/CT in Metastatic Prostate Cancer
Prostate Cancer Metastatic
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
RecruitingPhase 2
Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro)
Recurrent Prostate Cancer
RecruitingPhase 1/2
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
Liposarcoma, Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek Rosario, MD principal investigator
University of Sheffield / Sheffield Teaching Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aerobic exercise training in people with Prostate Cancer, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as measured by rate of recruitment (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.