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 @ 1:18 PM
Ignite Modification Date:
2025-12-24 @ 1:18 PM
NCT ID:
NCT05110495
Eligibility Criteria:
Inclusion Criteria:
A patient will be eligible for inclusion in this study if all of the following criteria apply.
1. Men with prostate adenocarcinoma confirmed on prostate biopsy and with sufficient cancer-containing biopsy tissue surplus to diagnostic need to provide 2 sections for primary endpoint analysis.
2. Scheduled for open or robotic radical prostatectomy
3. Age ≥ 18 years
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Appendix 1)
5. The patient is willing and able to comply with the protocol scheduled follow-up visits and examinations for the duration of the study
6. Participant is willing and able to give informed consent.
7. Participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 70 days thereafter.
8. Adequate hematologic, renal and hepatic function, defined as follows:
Laboratory Test Value required Hemoglobin (Hb) ≥90g/L White Blood Count (WBC) \>2.5 x 10\*9/L Absolute Neutrophil Count (ANC) ≥ 1.5 x10\*9/L Platelet count ≥ 100 x 10\*9/L AST, ALT, and alkaline phosphatase ≤ 2.5 x upper limit of normal eGFR\* ≥30ml/min
\*eGFR calculated by Cockcroft \& Gault formula,
Exclusion Criteria:
* A patient will not be eligible for the trial if any of the following apply:
1. Treated with systemic corticosteroids, insulin, metformin, other oral hypoglycemic agent, or anti-androgens in the 28 days prior to first dose of study drug
2. Diabetes mellitus
3. Previous prostate radiotherapy
4. Current or previous treatment with xentuzumab or other IGF or GH -modifying therapy
5. Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV
6. Treatment with any other investigational agent, or treatment in another interventional clinical trial within 28 days prior to enrolment
7. Other psychological, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT05110495
Study Brief:
Protocol Section:
NCT05110495