The Role of Follicle Stimulating Hormone in Advanced Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Case Control Study Regarding the Role of Follicle Stimulating Hormone in Chemically Castrated Young Men

Conditions
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Prostate Cancer Recurrent

Intervention / Treatment
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* Drug: Degarelix 120 MG [Firmagon]
* Drug: Gonal F RFF Pen 900 UNT Per 1.5 ML Pen Injector
* Drug: Testosterone Undecanoate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, non-smoking, body mass index 20-25, Exclusion Criteria: Medication or drug abuse -

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized case control study: one arm with FSH treatment for 5 weeks and one arm without FSH.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: GnRH antagonist + FSH + testosterone<br>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. | Drug: Degarelix 120 MG [Firmagon]<br>* Two doses of degarelix, 240 mg, subcutaneously once, at study start.<br>* Other names: Firmagon;Drug: Gonal F RFF Pen 900 UNT Per 1.5 ML Pen Injector<br>* Gonal-f 300 IU subcutaneously 3 times per week for 5 weeks.<br>* Other names: Gonadotropin;Drug: Testosterone Undecanoate<br>* One dose 1000 mg testosterone once, after 3 weeks.<br>* Other names: Nebido;|
| Other: GnRH antagonist + testosterone<br>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. | Drug: Degarelix 120 MG [Firmagon]<br>* Two doses of degarelix, 240 mg, subcutaneously once, at study start.<br>* Other names: Firmagon;Drug: Testosterone Undecanoate<br>* One dose 1000 mg testosterone once, after 3 weeks.<br>* Other names: Nebido;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA-concentration | Prostate marker | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FSH dependent proteins | Proteins identified by spectrophotometry | 5 weeks |