Clinical trial NCT04134130: The Role of Follicle Stimulating Hormone in Advanced Prostate Cancer
Official title: Case Control Study Regarding the Role of Follicle Stimulating Hormone in Chemically Castrated Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer Recurrent
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Swedish Cancer Foundation
name: ALF Swedish Government Grant
First posted: 2019-10-22
Enrollment: 33
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized case control study: one arm with FSH treatment for 5 weeks and one arm without FSH.
Primary purpose: OTHER

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.

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

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Primary outcomes:
measure: PSA-concentration
timeFrame: 5 weeks
Secondary outcomes:
measure: FSH dependent proteins
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Reproductive Medicine Center
Study officials:
affiliation: Lund University, dept Translational medicine
name: Yvonne Lundberg Giwercman, Professor
role: PRINCIPAL_INVESTIGATOR
References: