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The Role of Follicle Stimulating Hormone in Advanced Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04134130
Recruitment Status : Completed
First Posted : October 22, 2019
Last Update Posted : January 22, 2020
Sponsor:
Collaborators:
Swedish Cancer Foundation
ALF Swedish Government Grant
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Recurrent Drug: Degarelix 120 MG [Firmagon] Drug: Gonal F RFF Pen 900 UNT Per 1.5 ML Pen Injector Drug: Testosterone Undecanoate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized case control study: one arm with FSH treatment for 5 weeks and one arm without FSH.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Case Control Study Regarding the Role of Follicle Stimulating Hormone in Chemically Castrated Young Men
Actual Study Start Date : September 16, 2019
Actual Primary Completion Date : December 20, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
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 Name: 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 Name: Gonadotropin

Drug: Testosterone Undecanoate
One dose 1000 mg testosterone once, after 3 weeks.
Other Name: Nebido

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 Name: Firmagon

Drug: Testosterone Undecanoate
One dose 1000 mg testosterone once, after 3 weeks.
Other Name: Nebido




Primary Outcome Measures :
  1. PSA-concentration [ Time Frame: 5 weeks ]
    Prostate marker


Secondary Outcome Measures :
  1. FSH dependent proteins [ Time Frame: 5 weeks ]
    Proteins identified by spectrophotometry



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134130


Locations
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Sweden
Reproductive Medicine Center
Malmö, Sweden, 21428
Sponsors and Collaborators
Lund University
Swedish Cancer Foundation
ALF Swedish Government Grant
Investigators
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Principal Investigator: Yvonne Lundberg Giwercman, Professor Lund University, dept Translational medicine
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Responsible Party: Lund University
ClinicalTrials.gov Identifier: NCT04134130    
Other Study ID Numbers: 2019-01942
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents