Prostate Cancer RecurrentNCT04134130
The Role of Follicle Stimulating Hormone in Advanced Prostate Cancer
A study testing Degarelix 120 MG [Firmagon], Gonal F RFF Pen 900 UNT Per 1.5 ML Pen Injector and Testosterone Undecanoate in people with Prostate Cancer Recurrent, run by Lund University at 1 site in Sweden.
Trial summary
In order to elucidate if FSH can have testosterone like effects, samples from young, non-smoking healthy volunteers, with normal body mass index, and with pharmacologically induced gonadotropin deficiency will be studied regarding their capacity to induce prostate specific antigen (PSA), which normally is regulated by… Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer Recurrent
- What is being tested?
- Degarelix 120 MG [Firmagon], Gonal F RFF Pen 900 UNT Per 1.5 ML Pen Injector and Testosterone Undecanoate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSweden
- Study dates
- 16 Sep 2019to 31 Dec 2019
- 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Inclusion Criteria: Healthy, non-smoking, body mass index 20-25, Exclusion Criteria: Medication or drug abuse
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Case Control Study Regarding the Role of Follicle Stimulating Hormone in Chemically Castrated Young Men
In order to elucidate if FSH can have testosterone like effects, samples from young, non-smoking healthy volunteers, with normal body mass index, and with pharmacologically induced gonadotropin deficiency will be studied regarding their capacity to induce prostate specific antigen (PSA), which normally is regulated by testosterone.
Read the detailed description
Normally, prostate specific antigen (PSA), which is a marker for prostate disease and progression, is exclusively produced in response to testosterone. In order to elucidate if follicle stimulating hormone (FSH) can have testosterone like effects, samples from n=30 non-smoking healthy volunteers, 20-30 years of age and with normal body mass index (20-25) with pharmacologically induced gonadotropin deficiency will be studied. The men are currently recruited and during 5 weeks undergoing:
- Pharmacologically induced gonadotropin deficiency w 1-3;
- FSH-treatment of 50% (group A), w 1-5;
- Testosterone (T) treatment of all (group A and B) w 4-5;
- End and follow up after 5 weeks.
A subcutaneous injection with the GnRH antagonist degarelix (240 mg¸ Ferring GmbH Wittland, Kiel, Germany) results in drop of both FSH and LH-induced testosterone. Half of the men will get recombinant FSH (300 IU; Gonal-f, Merck Serrono S.A. Aubonne, Schweiz) back, whereas 50% will not. Three weeks thereafter, the full spectrum of FSH dependent changes occur and are reflected in blood. From this occasion testosterone (Nebido, Ferring GmbH Wittland, Kiel, Germany) will be given to all participants to diminish the side-effects of the castration. Blood samples are collected at start, after 3 wks and after 5 wks. At that point also a follow up is undertaken. This experimental design will provide samples from each individual during normal conditions, during castration, and after a standardised dose of FSH.
- Conditions
- Prostate Cancer Recurrent
- Being tested
- Degarelix 120 MG [Firmagon], Gonal F RFF Pen 900 UNT Per 1.5 ML Pen Injector, Testosterone Undecanoate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Degarelix 120 MG [Firmagon]Drug
Also called Firmagon
Two doses of degarelix, 240 mg, subcutaneously once, at study start.
Gonal F RFF Pen 900 UNT Per 1.5 ML Pen InjectorDrug
Also called Gonadotropin
Gonal-f 300 IU subcutaneously 3 times per week for 5 weeks.
Testosterone UndecanoateDrug
Also called Nebido
One dose 1000 mg testosterone once, after 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| GnRH antagonist + FSH + testosterone | Other | At the start of the study: 240 mg of the gonadotropin releasing hormone antagonist Degarelix (Ferring GmbH, Wittland, Kiel, Germany) + recombinant FSH (Gonal-f, Merck Serrono S.A. Aubonne, Schweiz), 300 IU every second day for 5 weeks.
After 3 weeks: 1000 mg testosterone once. Receives: Drug: Degarelix 120 MG [Firmagon]; Drug: Gonal F RFF Pen 900 UNT Per 1.5 ML Pen Injector; Drug: Testosterone Undecanoate |
| GnRH antagonist + testosterone | Other | At the start of the study: 240 mg of the gonadotropin releasing hormone antagonist Degarelix (Ferring GmbH, Wittland, Kiel, Germany).
After 3 weeks: 1000 mg testosterone (Nebido, Bayer AB, Solna, Sweden) once. Receives: Drug: Degarelix 120 MG [Firmagon]; Drug: Testosterone Undecanoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA-concentration
Prostate marker
Measured: 5 weeks
Secondary outcomes (1)
FSH dependent proteins
Proteins identified by spectrophotometry
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start16 Sep 2019
- Primary completion20 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer RecurrentStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized case control study: one arm with FSH treatment for 5 weeks and one arm without FSH.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Cancer Foundation, ALF Swedish Government Grant
- Responsible party
- Sponsor
- Investigators
- Yvonne Lundberg Giwercman, Professor, Principal investigator, Lund University, dept Translational medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134130
- Sponsor's protocol ID
- 2019-01942
- Other IDs
- 2019
- Status last verified
- Jan 2020
- First submitted
- 18 Oct 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Control Study Regarding the Role of Follicle Stimulating Hormone in Chemically Castrated Young Men
- ClinicalTrials.gov ID
- NCT04134130
- Acronym / sponsor ID
- 2019-01942
- Conditions
- Prostate Cancer Recurrent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Swedish Cancer Foundation, ALF Swedish Government Grant
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 22 Oct 2019 (actual)
- 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.
In order to elucidate if FSH can have testosterone like effects, samples from young, non-smoking healthy volunteers, with normal body mass index, and with pharmacologically induced gonadotropin deficiency will be studied regarding their capacity to induce prostate specific antigen (PSA), which normally is regulated by testosterone.
Detailed description
Normally, prostate specific antigen (PSA), which is a marker for prostate disease and progression, is exclusively produced in response to testosterone. In order to elucidate if follicle stimulating hormone (FSH) can have testosterone like effects, samples from n=30 non-smoking healthy volunteers, 20-30 years of age and with normal body mass index (20-25) with pharmacologically induced gonadotropin deficiency will be studied. The men are currently recruited and during 5 weeks undergoing:
- Pharmacologically induced gonadotropin deficiency w 1-3;
- FSH-treatment of 50% (group A), w 1-5;
- Testosterone (T) treatment of all (group A and B) w 4-5;
- End and follow up after 5 weeks.
A subcutaneous injection with the GnRH antagonist degarelix (240 mg¸ Ferring GmbH Wittland, Kiel, Germany) results in drop of both FSH and LH-induced testosterone. Half of the men will get recombinant FSH (300 IU; Gonal-f, Merck Serrono S.A. Aubonne, Schweiz) back, whereas 50% will not. Three weeks thereafter, the full spectrum of FSH dependent changes occur and are reflected in blood. From this occasion testosterone (Nebido, Ferring GmbH Wittland, Kiel, Germany) will be given to all participants to diminish the side-effects of the castration. Blood samples are collected at start, after 3 wks and after 5 wks. At that point also a follow up is undertaken. This experimental design will provide samples from each individual during normal conditions, during castration, and after a standardised dose of FSH.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized case control study: one arm with FSH treatment for 5 weeks and one arm without FSH.
| Arm | Type | Receives |
|---|---|---|
| GnRH antagonist + FSH + testosterone | Other | Drug: Degarelix 120 MG [Firmagon], Drug: Gonal F RFF Pen 900 UNT Per 1.5 ML Pen Injector, Drug: Testosterone UndecanoateAt the start of the study: 240 mg of the gonadotropin releasing hormone antagonist Degarelix (Ferring GmbH, Wittland, Kiel, Germany) + recombinant FSH (Gonal-f, Merck Serrono S.A. Aubonne, Schweiz), 300 IU every second day for 5 weeks. After 3 weeks: 1000 mg testosterone once. |
| GnRH antagonist + testosterone | Other | Drug: Degarelix 120 MG [Firmagon], Drug: Testosterone UndecanoateAt the start of the study: 240 mg of the gonadotropin releasing hormone antagonist Degarelix (Ferring GmbH, Wittland, Kiel, Germany). After 3 weeks: 1000 mg testosterone (Nebido, Bayer AB, Solna, Sweden) once. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Degarelix 120 MG [Firmagon]Also: FirmagonTwo doses of degarelix, 240 mg, subcutaneously once, at study start. | Drug | GnRH antagonist + FSH + testosterone, GnRH antagonist + testosterone |
| Gonal F RFF Pen 900 UNT Per 1.5 ML Pen InjectorAlso: GonadotropinGonal-f 300 IU subcutaneously 3 times per week for 5 weeks. | Drug | GnRH antagonist + FSH + testosterone |
| Testosterone UndecanoateAlso: NebidoOne dose 1000 mg testosterone once, after 3 weeks. | Drug | GnRH antagonist + FSH + testosterone, GnRH antagonist + testosterone |
Primary outcome
PSA-concentration
Time frame: 5 weeks
Prostate marker
1 secondary outcome
FSH dependent proteins
Time frame: 5 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 22 Jan 2020.
- 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.
Yvonne Lundberg Giwercman, Professor principal investigator
Lund University, dept Translational medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Degarelix 120 MG [Firmagon], Gonal F RFF Pen 900 UNT Per 1.5 ML Pen Injector and Testosterone Undecanoate in people with Prostate Cancer Recurrent, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 22 Jan 2020. 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 Sweden. 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-concentration (time frame: 5 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 22 Jan 2020.