Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT07299292
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years.
* Histologically confirmed prostate adenocarcinoma.
* Treated at Hospital Durand (Argentina) or Instituto Oncológico del Oriente Boliviano (Bolivia).
* Indicated for hormonal intensification (high/very high risk candidates for RT, or mHSPC for doublet/triplet).
* No prior ADT.
* ECOG 0-2; adequate hepatic/renal function; K+ ≥3.5 mmol/L; controlled BP.
Exclusion Criteria:
* Hypersensitivity to ABI/prednisone; moderate-severe hepatic impairment; uncontrolled hypertension; refractory hypokalemia.
* Concurrent therapy with strongly contraindicated/inducing drugs affecting ABI levels without possibility of adjustment.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT07299292
Study Brief:
Protocol Section:
NCT07299292