Prostate CancerPhase 3PEPCNCT00658229
The Physical Exercise and Prostate Cancer Study
A Phase 3 study testing Strength training group in people with Prostate Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to determine the effectiveness of a four months strength training program on physical and psychological health in patients with prostate cancer during androgen deprivation therapy. Read more about this study
- Who is it for?
- Ages Up to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Strength training group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2008to May 2012
- Phase
- Phase 3
- 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 Up to 75 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Newly diagnosed locally advanced prostate cancer (clinical stage T2 and T3)
- Referred to RH and UUS for radiotherapy
- < 75 years
- Capable of reading and writing Norwegian
- Treating oncologist must approve of the subjects' participation
- Living within approximately 1 hour from Oslo by car or public transportation
Who cannot join
- Routinely resistance training with manuals
- Medication for osteoporosis (i.e. bisphosphonates)
- Conditions of a severity that contraindicate exercise without adjusted actions
- Mentally incompetent conditions
- Conditions of a severity that complicates the ability to participate in a supervised training program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Exercise for Patients With Prostate Cancer During Androgen Deprivation Therapy - A Randomized Trial
The purpose of this study is to determine the effectiveness of a four months strength training program on physical and psychological health in patients with prostate cancer during androgen deprivation therapy. It is hypothesized a beneficial effect of the intervention on physical and psychological health in patients with prostate cancer treated with androgen deprivation.
- Conditions
- Prostate Cancer
- Being tested
- Strength training group
- Keywords
- Exercise, Prostatic, Neoplasm, Androgen, Deprivation
- Medical subject headings
- Prostatic Neoplasms, Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength training groupBehavioural
Also called Exercise, Physical activity
After 5-10 months on androgen deprivation therapy the patients in the intervention group go through a four months strength training intervention. The patients will perform three strength-training sessions per week, two under supervision of a sport instructor. Each session will consists of one-three sets of nine strength-training exercises, performed at an intensity of 6 or 10 repetitions of maximum (6-10 RM).
| Study group | Role | What they receive |
|---|---|---|
| Strength training group | Experimental | A four months strength training program during androgen deprivation therapy for prostate cancer patietns. Receives: Behavioral: Strength training group |
| Control group | No intervention | Patients in the control group are not discouraged from performing normal activities. They are however asked not to start a strength training program or increase their activity level in the same period as the experimental group is performing their strength training program. We will offer the control group a modified strength training program after the post-intervention assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
lean body mass
Measured: before ADT, before and after the intervention
Secondary outcomes (1)
bone mineral density, fat mass, body mass index, serological outcomes (including lipids, hormones and CRP), physical functioning, psycho-social functioning and muscle cellular outcomes (including muscle fiber size and function)
Measured: before ADT, before and after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startNov 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ullevaal University Hospital, Norwegian School of Sport Sciences, University of Alberta, University of Oslo, Norwegian Foundation for Health and Rehabilitation, The Royal Norwegian Ministry of Health
- Responsible party
- Principal investigator, Lene Thorsen, Oslo University Hospital
- Investigators
- Lene Thorsen, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658229
- Sponsor's protocol ID
- REK - 08/212b
- Acronym
- PEPC
- Status last verified
- Oct 2012
- First submitted
- 8 Apr 2008
- Last updated
- 15 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thorsen L, Nilsen TS, Raastad T, Courneya KS, Skovlund E, Fossa SD. A randomized controlled trial on the effectiveness of strength training on clinical and muscle cellular outcomes in patients with prostate cancer during androgen deprivation therapy: rationale and design. BMC Cancer. 2012 Mar 29;12:123. doi: 10.1186/1471-2407-12-123.
PubMed 22458865
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise for Patients With Prostate Cancer During Androgen Deprivation Therapy - A Randomized Trial
- ClinicalTrials.gov ID
- NCT00658229
- Acronym / sponsor ID
- PEPC / REK - 08/212b
- Conditions
- Prostate Cancer
- Keywords
- Exercise, Prostatic, Neoplasm, Androgen, Deprivation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Ullevaal University Hospital, Norwegian School of Sport Sciences, University of Alberta, University of Oslo, Norwegian Foundation for Health and Rehabilitation, The Royal Norwegian Ministry of Health
- Study start
- Nov 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 14 Apr 2008 (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 purpose of this study is to determine the effectiveness of a four months strength training program on physical and psychological health in patients with prostate cancer during androgen deprivation therapy. It is hypothesized a beneficial effect of the intervention on physical and psychological health in patients with prostate cancer treated with androgen deprivation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength training group | Experimental | Behavioral: Strength training groupA four months strength training program during androgen deprivation therapy for prostate cancer patietns. |
| Control group | No intervention | –Patients in the control group are not discouraged from performing normal activities. They are however asked not to start a strength training program or increase their activity level in the same period as the experimental group is performing their strength training program. We will offer the control group a modified strength training program after the post-intervention assessment. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Newly diagnosed locally advanced prostate cancer (clinical stage T2 and T3)
- Referred to RH and UUS for radiotherapy
- < 75 years
- Capable of reading and writing Norwegian
- Treating oncologist must approve of the subjects' participation
Key exclusion criteria (5 listed)
- Routinely resistance training with manuals
- Medication for osteoporosis (i.e. bisphosphonates)
- Conditions of a severity that contraindicate exercise without adjusted actions
- Mentally incompetent conditions
- Conditions of a severity that complicates the ability to participate in a supervised training program
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 |
|---|---|---|
| Strength training groupAlso: Exercise, Physical activityAfter 5-10 months on androgen deprivation therapy the patients in the intervention group go through a four months strength training intervention. The patients will perform three strength-training sessions per week, two under supervision of a sport instructor. Each session will consists of one-three sets of nine strength-training exercises, performed at an intensity of 6 or 10 repetitions of maximum (6-10 RM). | Behavioural | Strength training group |
Primary outcome
lean body mass
Time frame: before ADT, before and after the intervention
1 secondary outcome
bone mineral density, fat mass, body mass index, serological outcomes (including lipids, hormones and CRP), physical functioning, psycho-social functioning and muscle cellular outcomes (including muscle fiber size and function)
Time frame: before ADT, before and after the intervention
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 15 Oct 2012.
- Derived from this study: PubMed 22458865Thorsen L, Nilsen TS, Raastad T, Courneya KS, Skovlund E, Fossa SD. A randomized controlled trial on the effectiveness of strength training on clinical and muscle cellular outcomes in patients with prostate cancer during androgen deprivation therapy: rationale and design. BMC Cancer. 2012 Mar 29;12:123. doi: 10.1186/1471-2407-12-123.
Related trials for Prostate Cancer
Not yet recruitingObservational study
Assessment of Intelligent Algorithms for Detection, Diagnosis and Risk Stratification of Tumors of the Kidney and Prostate
Kidney Cancers, Prostate Cancer
Not yet recruiting
WATER IV PCa (AS Sub-study)
Localized Prostate Cancer
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingPhase 1
A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer
Castration Resistant Metastatic Prostate Cancer, Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
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.
Lene Thorsen, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Strength training group in people with Prostate Cancer, run by Oslo University Hospital at 1 site in Norway.
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 6 inclusion and 5 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 15 Oct 2012. 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 Norway. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
lean body mass (time frame: before ADT, before and after the intervention). 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 NCT00658229, 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 15 Oct 2012.