The Role of Follicle Stimulating Hormone in Advanced Prostate Cancer

Prostate Cancer Recurrent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04134130
• Other study ID #: 2019-01942
• Status: Completed
• Phase: N/A
• Start date: September 16, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 testosterone.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 31, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 30 Years

Eligibility

Inclusion Criteria: Healthy, non-smoking, body mass index 20-25, Exclusion Criteria:

Medication or drug abuse

-

Related Conditions & MeSH terms

• Prostate Cancer Recurrent
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix 120 MG [Firmagon]
Two doses of degarelix, 240 mg, subcutaneously once, at study start.
• Gonal F RFF Pen 900 UNT Per 1.5 ML Pen Injector
Gonal-f 300 IU subcutaneously 3 times per week for 5 weeks.
• Testosterone Undecanoate
One dose 1000 mg testosterone once, after 3 weeks.

Locations

Country	Name	City	State
Sweden	Reproductive Medicine Center	Malmö

Sponsors (3)

Lead Sponsor	Collaborator
Lund University	ALF Swedish Government Grant, Swedish Cancer Foundation

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA-concentration	Prostate marker	5 weeks
Secondary	FSH dependent proteins	Proteins identified by spectrophotometry	5 weeks