The Role of Follicle Stimulating Hormone in Advanced Prostate Cancer

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Malmö, Sweden, 21428
    • Reproductive Medicine Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lund University
• Collaborators: Swedish Cancer Foundation; ALF Swedish Government Grant
• Investigators: Principal Investigator: Yvonne Lundberg Giwercman, Professor, Lund University, dept Translational medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2019
• Primary Completion (Actual): December 20, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: October 18, 2019
• First Submitted That Met QC Criteria: October 18, 2019
• First Posted (Actual): October 22, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 21, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Androgens; Anabolic Agents; Testosterone; Methyltestosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
• Other Study ID Numbers: 2019-01942

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No