Prostate CancerNCT01584960
The Effect of Endurance Training in Patients With Prostate Cancer
A study testing endurance training in people with Prostate Cancer and Insulin Sensitivity, run by Inge Holm at 1 site in Denmark.
Trial summary
The aim of the present study is to investigate the effect of endurance on PSA doubling time in prostate cancer patients with an elevation in PSA following radical prostatectomy for localized cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Insulin Sensitivity, Body Composition, Beneficial
- What is being tested?
- endurance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2008to May 2012
- 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
- Prostate cancer patients with an increase in PSA following radical prostatectomy
Who cannot join
- severe cardiovascular disease
- severe arthritis
- severe neuropathy
- severe hypertension
- therapy with antidiabetic agents
- other treatment for prostate cancer than radical prostatectomy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Centre of Inflammation and Metabolism, Rigshospitalet
Copenhagen, Copenhagen, 2100
About this study
Official title: The Effect of Endurance Training on PSA Doubling Time, Body Composition, Insulin Sensitivity and Inflammation in Patients With Prostate Cancer
The aim of the present study is to investigate the effect of endurance on PSA doubling time in prostate cancer patients with an elevation in PSA following radical prostatectomy for localized cancer. Furthermore, underlying mechanisms such as reduction in inflammatory markers and improvement in insulin sensitivity and body composition are investigated.
- Being tested
- endurance training
- Medical subject headings
- Prostatic Neoplasms, Insulin Resistance, Glucocorticoid Receptor Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endurance trainingBehavioural
2 years of home-based endurance training
| Study group | Role | What they receive |
|---|---|---|
| Prostate cancer, endurance training | Experimental | Prostate cancer patients doing 2 years of home-based endurance training Cross over design with a control group with no intervention Receives: Behavioral: endurance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA doubling time
Measured: 2 years
Secondary outcomes (1)
Insulin sensitivity, body composition and inflammation status
Measured: 0 months, 6 months and 24 months of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startApr 2008
- Primary completionMay 2012
- Study completionMay 2012
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inge Holm
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital
- Responsible party
- Sponsor-investigator, Inge Holm, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Bente K Pedersen, Study director, Centre of Inflammation and Metabolism, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584960
- Sponsor's protocol ID
- H-D-2008-015
- Status last verified
- Nov 2013
- First submitted
- 24 Apr 2012
- Last updated
- 2 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Endurance Training on PSA Doubling Time, Body Composition, Insulin Sensitivity and Inflammation in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT01584960
- Acronym / sponsor ID
- H-D-2008-015
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Inge HolmUniversity, hospital or other
- Collaborators
- Herlev Hospital
- Study start
- Apr 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 25 Apr 2012 (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.
The aim of the present study is to investigate the effect of endurance on PSA doubling time in prostate cancer patients with an elevation in PSA following radical prostatectomy for localized cancer. Furthermore, underlying mechanisms such as reduction in inflammatory markers and improvement in insulin sensitivity and body composition are investigated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate cancer, endurance training | Experimental | Behavioral: endurance trainingProstate cancer patients doing 2 years of home-based endurance training Cross over design with a control group with no intervention |
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)
- Prostate cancer patients with an increase in PSA following radical prostatectomy
Key exclusion criteria (6 listed)
- severe cardiovascular disease
- severe arthritis
- severe neuropathy
- severe hypertension
- therapy with antidiabetic agents
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 |
|---|---|---|
| endurance training2 years of home-based endurance training | Behavioural | Prostate cancer, endurance training |
Primary outcome
PSA doubling time
Time frame: 2 years
1 secondary outcome
Insulin sensitivity, body composition and inflammation status
Time frame: 0 months, 6 months and 24 months of training
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 2 Dec 2013.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Bente K Pedersen study director
Centre of Inflammation and Metabolism, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endurance training in people with Prostate Cancer and Insulin Sensitivity, run by Inge Holm 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 6 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 2 Dec 2013. 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?
PSA doubling time (time frame: 2 years). 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 2 Dec 2013.