Short-term Testosterone Replacement in Testicular Cancer Survivors

NCT03339635 | Completed Phase 2 DMC

• 1 other identifier: 201600107
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Testicular Cancer

Outcome Measures

Primary Outcomes (1)

• percent change in fat mass as measured using using full body dual X-ray absorptiometry

  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).

  20 weeks of treatment

Secondary Outcomes (2)

• Effect of treatment with testosterone gel

  20 and 40 weeks of treatment

• Effect of treatment with testosterone gel

  20 and 40 weeks of treatment

Study Arms (2)

Testosterone gel

EXPERIMENTAL

Patients will be randomized to treatment with transdermal testosterone gel (Androgel) once daily during 20 weeks, followed by 20 weeks of active Androgel treatment in all participants.

Drug: Androgel (Testosterone gel)

Placebo gel

PLACEBO COMPARATOR

Patients will be randomized to treatment with placebo gel once daily during 20 weeks, followed by 20 weeks of active Androgel treatment in all participants.

Drug: Androgel (Testosterone gel); Drug: Placebo gel

Interventions

Androgel (Testosterone gel) DRUG

Patients will be randomized to treatment with transdermal testosterone gel (Androgel) once daily during 20 weeks, followed by 20 weeks of active Androgel treatment in all participants.

Also known as: Androgel

Placebo gel; Testosterone gel

Placebo gel DRUG

Patients will be randomized to treatment with transdermal placebo gel once daily during 20 weeks, followed by 20 weeks of active Androgel treatment in all participants.

Also known as: Placebo

Placebo gel

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Testicular Neoplasms

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Janine Nuver, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: November 13, 2017
• Study Start: December 21, 2018
• Primary Completion: June 26, 2024
• Study Completion: June 26, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)