Prostate CancerPhase 4NCT02102646
MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism
A Phase 4 study testing Triptorelin and Orchiectomy in people with Prostate Cancer and Metabolic Syndrome, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate if androgen deprivation therapy in men with prostate cancer increases hepatic fat content and changes visceral/subcutaneous fat distribution. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer, Metabolic Syndrome, Hypogonadism
- What is being tested?
- Triptorelin and Orchiectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2014to Oct 2015
- Phase
- Phase 4
- 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 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible for inclusion are patients who are included in the already ongoing Randomised trial entitled: Metabolic Changes Due to Iatrogenic Hypogonadism in Patients With Prostate Cancer: Orchiectomy vs. Triptorelin (EudraCT number: 2013-002553-29)
Who cannot join
- Implanted devices or foreign metallic bodies incompatible with Magnetic Resonance Imaging.
- claustrophobia
- Severe Psychiatric disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism in Patients With Prostate Cancer: Orchiectomy vs. Triptorelin
The purpose of this study is to investigate if androgen deprivation therapy in men with prostate cancer increases hepatic fat content and changes visceral/subcutaneous fat distribution.
Read the detailed description
This is a substudy of the ongoing randomized trial entitled: Metabolic Changes Due to Iatrogenic Hypogonadism in Patients With Prostate Cancer: Orchiectomy vs. Triptorelin (EudraCT number: 2013-002553-29). 20 consecutive patients are anticipated to participate regardless of assignment to either orchiectomy or triptorelin.
- Conditions
- Prostate Cancer, Metabolic Syndrome, Hypogonadism, Fatty Liver
- Being tested
- Triptorelin, Orchiectomy
- Medical subject headings
- Prostatic Neoplasms, Metabolic Syndrome, Hypogonadism, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriptorelinDrug
Also called Pamorelin
Androgen deprivation therapy by Pamorelin 22,5mg/24 weeks administered intramuscularly.
OrchiectomyProcedure or surgery
Also called Subcapsular orchiectomy
Androgen deprivation therapy by bilateral subcapsular orchiectomy
| Study group | Role | What they receive |
|---|---|---|
| Triptorelin | Active comparator | Triptorelin 22,5mg/24th week intramuscularly Receives: Drug: Triptorelin |
| orchiectomy | Active comparator | Androgen deprivation therapy by bilateral subcapsular orchiectomy Receives: Procedure: Orchiectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hepatic fat content
Change in hepatic fat content measured by Magnetic Resonance Spectroscopy
Measured: At baseline (within 4 weeks of commencement of androgen deprivation therapy) and after 24 weeks
Secondary outcomes (2)
Change in visceral/subcutaneous fat mass
Changes in visceral and subcutaneous fat mass measured by Magnetic Resonance Imaging.
Measured: At baseline (within 4 weeks of commencement of androgen deprivation therapy) and after 24 weeks
Correlation between Hepatic fat content and baseline androgen status
To investigate possible correlation between androgen status before commencing androgen deprivation therapy and hepatic fat content at baseline.
Measured: Androgen status measured before commencement of androgen deprivation therapy (ADT), hepatic fat content measured at baseline (within 1 month of commencing androgen deprivation therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionOct 2015
- Study completionOct 2015
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 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, Department of Urology, Herlev Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102646
- Sponsor's protocol ID
- kk2013 MRI
- Status last verified
- Oct 2015
- First submitted
- 27 Mar 2014
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism in Patients With Prostate Cancer: Orchiectomy vs. Triptorelin
- ClinicalTrials.gov ID
- NCT02102646
- Acronym / sponsor ID
- kk2013 MRI
- Conditions
- Prostate Cancer, Metabolic Syndrome, Hypogonadism, Fatty Liver
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 3 Apr 2014 (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 investigate if androgen deprivation therapy in men with prostate cancer increases hepatic fat content and changes visceral/subcutaneous fat distribution.
Detailed description
This is a substudy of the ongoing randomized trial entitled: Metabolic Changes Due to Iatrogenic Hypogonadism in Patients With Prostate Cancer: Orchiectomy vs. Triptorelin (EudraCT number: 2013-002553-29). 20 consecutive patients are anticipated to participate regardless of assignment to either orchiectomy or triptorelin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triptorelin | Active comparator | Drug: TriptorelinTriptorelin 22,5mg/24th week intramuscularly |
| orchiectomy | Active comparator | Procedure: OrchiectomyAndrogen deprivation therapy by bilateral subcapsular orchiectomy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible for inclusion are patients who are included in the already ongoing Randomised trial entitled: Metabolic Changes Due to Iatrogenic Hypogonadism in Patients With Prostate Cancer: Orchiectomy vs. Triptorelin (EudraCT number: 2013-002553-29)
Key exclusion criteria (3 listed)
- Implanted devices or foreign metallic bodies incompatible with Magnetic Resonance Imaging.
- claustrophobia
- Severe Psychiatric disease
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 |
|---|---|---|
| TriptorelinAlso: PamorelinAndrogen deprivation therapy by Pamorelin 22,5mg/24 weeks administered intramuscularly. | Drug | Triptorelin |
| OrchiectomyAlso: Subcapsular orchiectomyAndrogen deprivation therapy by bilateral subcapsular orchiectomy | Procedure or surgery | orchiectomy |
Primary outcome
Change in hepatic fat content
Time frame: At baseline (within 4 weeks of commencement of androgen deprivation therapy) and after 24 weeks
Change in hepatic fat content measured by Magnetic Resonance Spectroscopy
2 secondary outcomes
Change in visceral/subcutaneous fat mass
Time frame: At baseline (within 4 weeks of commencement of androgen deprivation therapy) and after 24 weeks
Correlation between Hepatic fat content and baseline androgen status
Time frame: Androgen status measured before commencement of androgen deprivation therapy (ADT), hepatic fat content measured at baseline (within 1 month of commencing androgen deprivation therapy)
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 28 Oct 2015.
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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
Department of Urology, Herlev Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triptorelin and Orchiectomy in people with Prostate Cancer and Metabolic Syndrome, 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 28 Oct 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in hepatic fat content (time frame: At baseline (within 4 weeks of commencement of androgen deprivation therapy) and after 24 weeks). 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 28 Oct 2015.