Testosterone decanoate; Testosterone isocaproate; Testosterone phenylpropionate; Testosterone propionate for Androgen deficiency | Palliative care

Inclusion criteria

• {"criterion_text":"- 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.\n- Age ≥ 18 years old\n- 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

• {"criterion_text":"- Untreated relapsed or metastatic prostate cancer, given the risk of epiduritis.\n- Known hypersensitivity reactions to the study drug or to any excipients\n- Known allergies to peanuts or soya."}

Primary endpoints

• {"endpoint_text":"- 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\n- 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","definition_or_measurement_approach":"Measured using the ADL independence scale and the Edmonton Symptom Assessment Scale. Questionnaires completed before injection on day 0 and then every 15 days at time of injection until subject's death or discontinuation."}

Secondary endpoints

• {"endpoint_text":"- 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.\n- Improvement of quality of life of subjects from the point of view of a proxy using the EQ-5D-3L questionnaire.","definition_or_measurement_approach":"Average scores of ADL and Edmonton Symptom Assessment Scale during treatment after baseline; assessments at each time point (notably D15). Proxy-reported quality of life measured using the EQ-5D-3L questionnaire."}

Belgium

Earliest CTIS Part Ii Submission Date

05-09-2025

Latest Decision Or Authorization Date

31-10-2025

Processing Time Days

56

Number Of Sites

1

Number Of Participants

25

Primary sponsor

Full Name

Institut Jules Bordet

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium