Prostatic NeoplasmsNCT02631681
Supervised Group Based Exercise for Men With Prostate Cancer on Androgen Deprivation Therapy
A study testing Group based exercise in people with Prostatic Neoplasms and Exercise Therapy, run by Herlev Hospital at 1 site in Denmark.
Trial summary
Exercise intervention for men with prostate cancer on androgen deprivation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms, Exercise Therapy, Androgen Deprivation Therapy
- What is being tested?
- Group based exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2014to Sep 2017
- Phase
- Interventional
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a prostate cancer diagnosis on androgen deprivation therapy
Who cannot join
- Opioid demanding treatment for skeletal pain
- Eastern Cooperative Oncology Group performance status > 2
- Inability to perform floor and machine exercises independently
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Herlev and Gentofte Hospital
Herlev, Please Select An Option Below, 2100
About this study
Exercise intervention for men with prostate cancer on androgen deprivation therapy.
Read the detailed description
The aim of the project is to investigate the effects of patient education and exercise intervention implemented in daily clinical practice for men with prostate cancer on androgen deprivation therapy
- Functional capacity
- Quality of life
- Body composition
- Blood pressure and to assess safety of progressive resistance training for participants with bone metastases.
- Being tested
- Group based exercise
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group based exerciseBehavioural
Supervised group based combined aerobic and resistance training for 12 weeks as part of our normal clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Men with prostate cancer on androgen deprivation therapy | Experimental | Group based supervised combined aerobic and resistance training for 12 weeks. Receives: Behavioral: Group based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 30second Chair-Stand test (30s-CST)
Test of functional capacity, measured as change
Measured: Baseline, 12 and 24 weeks
Change in Graded Cycling Test with Talk Test (GCT-TT)
Test of functional capacity, measured as change
Measured: Baseline, 12 and 24 weeks
Secondary outcomes (5)
change in QoL
European Organisation for Research and Treatment of Cancer (EORTC) cancer and prostate specific questionnaires: EORTC QLQC-30 version 3.0 and PR25
Measured: Baseline, 12 and 24 weeks
change in Body composition
BMI, waist and hip circumference, waist-hip ratio.
Measured: Baseline, 12 and 24 weeks
change in Bloodpressure
Systolic and diastolic bloodpressure
Measured: Baseline, 12 and 24 weeks
Safety of exercise assessed by serious adverse events according to the FDA
Measured: Study period baseline - 24 weeks
Compliance assessed by attendance and continued exercise (yes/no)
Measured: Baseline, 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startAug 2014
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Busch Østergren, Herlev Hospital
- Investigators
- Peter B Østergren, MD, Principal investigator, Herlev and Gentofte Hospital, Faculty of Health and Medical Sciences, Copenhagen University, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631681
- Sponsor's protocol ID
- ProstEx
- Status last verified
- Aug 2019
- First submitted
- 10 Dec 2015
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ostergren P, Ragle AM, Jakobsen H, Klausen TW, Vinther A, Sonksen J. Group-based exercise in daily clinical practice to improve physical fitness in men with prostate cancer undergoing androgen deprivation therapy: study protocol. BMJ Open. 2016 Jun 29;6(6):e011460. doi: 10.1136/bmjopen-2016-011460.
PubMed 27357198
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supervised Group Based Exercise for Men With Prostate Cancer on Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT02631681
- Acronym / sponsor ID
- ProstEx
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 16 Dec 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.
Exercise intervention for men with prostate cancer on androgen deprivation therapy.
Detailed description
The aim of the project is to investigate the effects of patient education and exercise intervention implemented in daily clinical practice for men with prostate cancer on androgen deprivation therapy
- Functional capacity
- Quality of life
- Body composition
- Blood pressure and to assess safety of progressive resistance training for participants with bone metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men with prostate cancer on androgen deprivation therapy | Experimental | Behavioral: Group based exerciseGroup based supervised combined aerobic and resistance training for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a prostate cancer diagnosis on androgen deprivation therapy
Key exclusion criteria (3 listed)
- Opioid demanding treatment for skeletal pain
- Eastern Cooperative Oncology Group performance status > 2
- Inability to perform floor and machine exercises independently
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 |
|---|---|---|
| Group based exerciseSupervised group based combined aerobic and resistance training for 12 weeks as part of our normal clinical practice. | Behavioural | Men with prostate cancer on androgen deprivation therapy |
Primary outcome
Change in 30second Chair-Stand test (30s-CST)
Time frame: Baseline, 12 and 24 weeks
Test of functional capacity, measured as change
Change in Graded Cycling Test with Talk Test (GCT-TT)
Time frame: Baseline, 12 and 24 weeks
Test of functional capacity, measured as change
5 secondary outcomes
change in QoL
Time frame: Baseline, 12 and 24 weeks
change in Body composition
Time frame: Baseline, 12 and 24 weeks
change in Bloodpressure
Time frame: Baseline, 12 and 24 weeks
Safety of exercise assessed by serious adverse events according to the FDA
Time frame: Study period baseline - 24 weeks
Compliance assessed by attendance and continued exercise (yes/no)
Time frame: Baseline, 12 and 24 weeks
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 Aug 2019.
- Derived from this study: PubMed 27357198Ostergren P, Ragle AM, Jakobsen H, Klausen TW, Vinther A, Sonksen J. Group-based exercise in daily clinical practice to improve physical fitness in men with prostate cancer undergoing androgen deprivation therapy: study protocol. BMJ Open. 2016 Jun 29;6(6):e011460. doi: 10.1136/bmjopen-2016-011460.
- Individual participant dataSharing planned: No
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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.
Peter B Østergren, MD principal investigator
Herlev and Gentofte Hospital, Faculty of Health and Medical Sciences, Copenhagen University, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group based exercise in people with Prostatic Neoplasms and Exercise Therapy, run by Herlev Hospital at 1 site in Denmark.
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 1 inclusion and 3 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 Aug 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 Denmark. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in 30second Chair-Stand test (30s-CST) (time frame: Baseline, 12 and 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02631681, which also lists 1 linked publication.
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 Aug 2019.