Testicular cancer
Conditions
Interventions
Product Name: testosterone gel (Androgel)
Product Code: testosterone gel (Androgel)
Pharmaceutical Form: Gel
INN or Proposed INN: TESTOSTERONE
Other descriptive name: transdermal testosterone gel (And
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: We will include patients with metastatic testicular cancer after chemotherapy, at least 12 months after completion of last treatment and without evidence of disease. Combination chemotherapy should have contained a platinum compound, either cisplatin or carboplatin. In TC survivors, testosterone levels are routinely measured in blood during follow-up once every two years. Patients are eligible for screening if they are between 18 and 55 years of age, and have a documented low or low-normal total testosterone level =14 nmol/L, as measured during any of the follow-up visits, irrespective of signs and symptoms of androgen deficiency. Eligible for actual study participation and randomization between Androgel and placebo will be: survivors of TC not using testosterone supplements, having biochemical evidence of hypogonadism (defined as a serum total testosterone concentration = 12 nmol/L (345 ng/dL) measured after an overnight fast between 8:00 and 10:00 AM), and being overweight (as defined by a BMI = 25 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: We will exclude: patients planning to father children within the next 12 months; patients already treated for hypogonadism, patients taking corticosteroids or hormone replacement other than testosterone with dose-adjustments within the last 3 months prior to randomization; patients taking medication with any antiandrogenic effects (e.g. spironolactone); patients with signs or history of hormone-dependent cancer (prostate or breast cancer); patients with severe lower urinary tract symptoms (as defined by International Prostate Symptom Score >19); patients with a history of coronary artery disease (angina pectoris, myocardial infarction) or heart failure; patients with hematocrit >50%; patients with untreated severe obstructive sleep apnea; patients with uncontrolled hypertension; patients with a BMI > 35 kg/m2; patients with a history of epilepsy; patients with debilitating psychiatric illness or inability to understand the study protocol, according to the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of 20 weeks of treatment with testosterone gel on fat mass as measured using full body dual X-ray absorptiometry (DEXA scan).;Secondary Objective: To assess the effects of 20 and 40 weeks of treatment with testosterone gel on: 1. abdominal visceral fat mass as measured using full body DEXA scan. 2. clinical parameters of adiposity, including BMI and waist circumference 3. components of the metabolic syndrome, including blood pressure en serum lipids 4. serum levels of androgens and adipocytokines 5. quality of life, sexual health, and androgen deficiency symptoms 6. testicular volume and semen quality 7. bone mass density using DEXA scan and serum bone markers 8. cellular senescence and SASP;Primary end point(s): Main endpoint is the change in fat mass (as expressed in percentage) on full body Dual-Energy X-ray Absorption (DEXA) scan after 20 weeks of treatment with testosterone gel compared with placebo.;Timepoint(s) of evaluation of this end point: After 20 weeks of treatment with testosterone gel compared with placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end points are changes in the following parameters after 20 and 40 weeks of testosterone treatment compared with placebo: • Fat mass, visceral abdominal fat and lean mass using DEXA scan • Prevalence of the metabolic syndrome • Resting blood pressure • Muscle strength • Fasting lipid levels, glucose, insulin, HOMA-index, and HbA1c • Obesity parameters: BMI, waist circumference, waist-hip ratio, and adipocytokines measured in blood • Bone metabolism: bone mass density using DEXA scan, and osteocalcin and vitamine D levels in blood • Hormones of the pituitary-testicular axis • Testicular volume and semen quality • Quality of life, sexual health, and androgen deficiency symptoms as assessed using validated questionnaires • Senescence-marker p16 and SASP measured in blood • Testicular volume and semen quality • Quality of life, sexual health, and androgen deficiency symptoms as assessed using validated questionnaires ;Timepoint(s) of evaluation of this end point: After 20 and 40 weeks of testosterone treatment compared with placebo | — |
Countries
Netherlands
Contacts
Public ContactPrincipal investigator
University Medical Center Groningen
Outcome results
None listed