Short-term Testosterone Replacement in Testicular Cancer Survivors

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

To assess the effects of testosterone replacement therapy on fat mass and other components of the metabolic syndrome. A randomized double-blind placebo controlled intervention study, followed by an open-label treatment phase. Results of this pilot study will be used to design a multicenter randomized controlled study in a large group of TC survivors

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• patients with metastatic testicular cancer after unilateral orchidectomy and 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

• 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 <35 kg/m2).

• Patients should be able to understand and abide to the study protocol and sign written informed consent.

Exclusion Criteria:

• patients with a history of extragonadal testicular cancer

• patients planning to father children within the next 12 months

• patients taking corticosteroids or hormone replacement other than testosterone within 3 months of 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