The Role of Follicle Stimulating Hormone in Advanced Prostate Cancer

Not Applicable

Completed

• Conditions: Prostate Cancer Recurrent
• Interventions: Drug: Degarelix 120 MG [Firmagon]; Drug: Gonal F RFF Pen 900 UNT Per 1.5 ML Pen Injector; Drug: Testosterone Undecanoate

• Registration Number: NCT04134130
• Lead Sponsor: Lund University

Brief 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 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:

1. Pharmacologically induced gonadotropin deficiency w 1-3;

2. FSH-treatment of 50% (group A), w 1-5;

3. Testosterone (T) treatment of all (group A and B) w 4-5;

4. 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 Timeline

• Study Start: 2019-09-16
• Study First Submitted: 2019-10-18
• Study First Submitted QC: 2019-10-18
• Study First Posted: 2019-10-22
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 33

Inclusion Criteria

Healthy, non-smoking, body mass index 20-25,

Exclusion Criteria

Medication or drug abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GnRH antagonist + FSH + testosterone	Gonal F RFF Pen 900 UNT Per 1.5 ML Pen Injector	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.
GnRH antagonist + FSH + testosterone	Testosterone Undecanoate	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.
GnRH antagonist + FSH + testosterone	Degarelix 120 MG [Firmagon]	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.
GnRH antagonist + testosterone	Testosterone Undecanoate	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.
GnRH antagonist + testosterone	Degarelix 120 MG [Firmagon]	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.

Primary Outcome Measures

Name	Time	Method
PSA-concentration	5 weeks	Prostate marker

Secondary Outcome Measures

Name	Time	Method
FSH dependent proteins	5 weeks	Proteins identified by spectrophotometry

Trial Locations

Locations (1)

Reproductive Medicine Center; 🇸🇪 Malmö, Sweden