Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruiting
Participants planned
25
Countries
1
Sites
1
Androgen deficiency, palliative care
To evaluate the impact of testosterone supplementation on the quality of life of male patients in best supportive care with no therapeutic options left and who do not wish to be reanimated.
Key facts
- Sponsor
- Institut Jules Bordet
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 11 Feb 2026 → ongoing
- Decision date (initial)
- 2025-09-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- The trial is financed from the Institut Jules Bordet's own funds
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To evaluate the impact of testosterone supplementation on the quality of life of male patients in best supportive care with no therapeutic options left and who do not wish to be reanimated.
Secondary objectives 2
- To further explore the dynamic/change of the ADL and Edmonton Symptom Assessment Scale during treatment
- To evaluate the impact of testosterone supplementation on the quality of life of male patients in best supportive care with no therapeutic options left and who do not wish to be reanimated from the point of view of someone close to the participant
Conditions and MedDRA coding
Androgen deficiency, palliative care
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.1 | PT | 10002261 | Androgen deficiency | 100000004860 |
| 20.0 | PT | 10059513 | Palliative care | 100000004865 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Main Trial This is a monocentric, single-arm prospective pilot study that will enrol hypogonadal
(total testosterone < 231 ng/dL) male subjects in best supportive care, with no further therapeutic
options and no need for resuscitation.
|
Not Applicable | None | Treatment: 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. 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 proxy |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Male hypogonadal cancer patient with total testosterone < 231 ng/dl receiving best supportive care with no further therapeutic options and who do not wish to be reanimated.
- Age ≥ 18 years old
- 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 3
- Untreated relapsed or metastatic prostate cancer, given the risk of epiduritis.
- Known hypersensitivity reactions to the study drug or to any excipients
- Known allergies to peanuts or soya.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Best improvement over time in independence using the ADL independence scale in terms of personal hygiene, dressing, going to the toilet, locomotion, continence and eating
- Best improvement over time in symptoms of pain, fatigue, sadness, anxiety, drowsiness, appetite, sense of well-being, shortness of breath, bowel movements and strength using the Edmonton Symptom Assessment Scale
Secondary endpoints 2
- The average of ADL and Edmonton Symptom Assessment Scale during treatment after baseline. The ADL and Edmonton System Assessment Scale at each time point during treatment, especially at D15.
- Improvement of quality of life of subjects from the point of view of a proxy using the EQ-5D-3L questionnaire.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Sustanon 250, solution injectable
PRD2611583 · Product
- Active substance
- Testosterone Decanoate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENUS USE
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 1 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03BA03 — TESTOSTERONE
- Marketing authorisation
- BE012704
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut Jules Bordet
- Sponsor organisation
- Institut Jules Bordet
- Address
- Mijlenmeersstraat 90
- City
- Anderlecht
- Postcode
- 1070
- Country
- Belgium
Scientific contact point
- Organisation
- Institut Jules Bordet
- Contact name
- CTSU
Public contact point
- Organisation
- Institut Jules Bordet
- Contact name
- CTSU
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruiting | 25 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Institut Jules Bordet
Palliative care, Mijlenmeersstraat 90, 1070, Anderlecht
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2026-02-11 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 18 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_protocol_2025-522023-10_Redacted | 1.2 |
| Protocol (for publication) | D4_Questionnaire_ADL_FR | 1.0 |
| Protocol (for publication) | D4_Questionnaire_ADL_NL | 1.0 |
| Protocol (for publication) | D4_Questionnaire_EQ-5D-3L_FR | 1.1 |
| Protocol (for publication) | D4_Questionnaire_EQ-5D-3L_NL | 1.1 |
| Protocol (for publication) | D4_Questionnaire_ESAS_FR | 1.0 |
| Protocol (for publication) | D4_Questionnaire_ESAS_NL | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment_arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Relative_BE_FR | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF_Relative_BE_NL | 1.1 |
| Subject information and informed consent form (for publication) | L1_Recruitment_Informed_consent_procedure | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_BE_FR_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_BE_NL_Redacted | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Sustanon_250 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_DE_2025-522023-10 | 1.2 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_EN_2025-522023-10 | 1.2 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_FR_2025-522023-10 | 1.2 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_NL_2025-522023-10 | 1.2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-14 | Belgium | Acceptable 2025-09-29
|
2025-09-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-02 | Belgium | Acceptable | 2025-10-31 |