The Role of Follicle Stimulating Hormone in Advanced Prostate Cancer
NCT ID: NCT04134130
Last Updated: 2020-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2019-09-16
2019-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
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.
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.
Degarelix 120 MG [Firmagon]
Two doses of degarelix, 240 mg, subcutaneously once, at study start.
Testosterone Undecanoate
One dose 1000 mg testosterone once, after 3 weeks.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
20 Years
30 Years
MALE
Yes
Sponsors
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Swedish Cancer Foundation
OTHER
ALF Swedish Government Grant
UNKNOWN
Lund University
OTHER
Responsible Party
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Principal Investigators
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Yvonne Lundberg Giwercman, Professor
Role: PRINCIPAL_INVESTIGATOR
Lund University, dept Translational medicine
Locations
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Reproductive Medicine Center
Malmo, , Sweden
Countries
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Other Identifiers
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2019-01942
Identifier Type: -
Identifier Source: org_study_id
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