Prostate Cancer Recurrent
Conditions
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.
Interventions
DRUGDegarelix 120 MG [Firmagon]
Two doses of degarelix, 240 mg, subcutaneously once, at study start.
DRUGGonal F RFF Pen 900 UNT Per 1.5 ML Pen Injector
Gonal-f 300 IU subcutaneously 3 times per week for 5 weeks.
DRUGTestosterone Undecanoate
One dose 1000 mg testosterone once, after 3 weeks.
Sponsors
Swedish Cancer Foundation
ALF Swedish Government Grant
Lund University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomized case control study: one arm with FSH treatment for 5 weeks and one arm without FSH.
Eligibility
Sex/Gender
MALE
Age
20 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy, non-smoking, body mass index 20-25,
Exclusion criteria
Medication or drug abuse \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PSA-concentration | 5 weeks | Prostate marker |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FSH dependent proteins | 5 weeks | Proteins identified by spectrophotometry |
Countries
Sweden
Outcome results
None listed