Testosterone Supplementation in Patients in Best Supportive Care: Impact on Quality of Life (TestoSup)

Free University of Brussels (ULB)

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Hypotestosteronism; Palliative Care

Treatments: Drug: Sustanon 250

Study type: Interventional

Funder types: Other

Identifiers

NCT07143279

IJB-SP01-2025

2025-522023-10-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

This is a monocentric, single-arm prospective pilot study that will enrol hypogonadal (testosterone < 231 ng/dL) male subjects in best supportive care, with no further therapeutic options and no need for resuscitation.

Currently, testosterone formulations for intramuscular (IM) injection and subcutaneous injection as well as for oral and transdermal administration have been approved for androgen therapy. To date, injectable testosterone is the most commonly used formulation. To increase serum testosterone levels to the physiological range IM injections of testosterone every 2-3 weeks are required, which lead to supraphysiological peaks shortly after administration, followed by a sharp fall in levels thereafter. Testosterone levels before the next injection are frequently in the hypogonadal range. For this reason, Sustanon 250® (1 ml, IM) will be administered on day 0 after confirmation of hypogonadism by blood test and then every 15 days in this trial given the limited life expectancy of the subjects and to maximise the effect and benefit of testosterone supplementation.

The Edmonton questionnaire and ADL questionnaire will be completed before the injection on day 0 and then every 15 days at the time of injection until subject's death or if a subject is discontinued from the study treatment/procedures for any other reasons than death. In parallel, the EQ-5D-3L questionnaire will be completed by a family member or a proxy.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male hypogonadal with total testosterone < 231 ng/dl in best supportive care with no further therapeutic options and who do not wish to be reanimated.
2. Age ≥ 18 years old
3. Patient able to understand the patient information sheet and able to sign the Informed Consent form (ICF) prior to any study related procedure.

Exclusion criteria

1. Untreated prostate cancer, given the risk of epiduritis.
2. Known hypersensitivity reactions to the study drug or to any excipients.
3. Known allergies to peanuts or soya.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Testosterone supplementation in patients in best supportive care: impact on quality of life

Experimental group

Description:

Single-arm prospective pilot study that will enrol hypogonadal (testosterone \< 231 ng/dL) male subjects in best supportive care, with no further therapeutic options and no need for resuscitation. Administration of Sustanon 250® (1 ml, IM) on day 0 after confirmation of hypogonadism by blood test and then every 15 days.

Treatment:

Drug: Sustanon 250