The Role of Follicle Stimulating Hormone in Advanced Prostate Cancer

NCT04134130 | Completed

• 1 other identifier: 2019-01942
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer Recurrent

Outcome Measures

Primary Outcomes (1)

• PSA-concentration

  Prostate marker

  5 weeks

Secondary Outcomes (1)

• FSH dependent proteins

  5 weeks

Study Arms (2)

GnRH antagonist + FSH + testosterone

OTHER

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]; Drug: Gonal F RFF Pen 900 UNT Per 1.5 ML Pen Injector; Drug: Testosterone Undecanoate

GnRH antagonist + testosterone

OTHER

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]; Drug: Testosterone Undecanoate

Interventions

Degarelix 120 MG [Firmagon] DRUG

Two doses of degarelix, 240 mg, subcutaneously once, at study start.

Also known as: Firmagon

GnRH antagonist + FSH + testosterone; GnRH antagonist + testosterone

Gonal F RFF Pen 900 UNT Per 1.5 ML Pen Injector DRUG

Gonal-f 300 IU subcutaneously 3 times per week for 5 weeks.

Also known as: Gonadotropin

GnRH antagonist + FSH + testosterone

Testosterone Undecanoate DRUG

One dose 1000 mg testosterone once, after 3 weeks.

Also known as: Nebido

GnRH antagonist + FSH + testosterone; GnRH antagonist + testosterone

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Lund University: lead
• Swedish Cancer Foundation: collaborator
• ALF Swedish Government Grant: collaborator

Study Sites (1)

Reproductive Medicine Center

Malmo, 21428, Sweden

Location

MeSH Terms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; Gonadotropins; testosterone undecanoate

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Yvonne Lundberg Giwercman, Professor

  Lund University, dept Translational medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized case control study: one arm with FSH treatment for 5 weeks and one arm without FSH.

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 22, 2019
• Study Start: September 16, 2019
• Primary Completion: December 20, 2019
• Study Completion: December 31, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)