Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05580107

Sponsor: Med Discovery SA

Phase: Phase 1

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Exclusion Criteria:

1. for the screening phase. For the patients not participating in the screening phase (ie patients with previously established PCa diagnosis), all the criteria above shall be checked prior to enrolment in the treatment phase. However, these patients do not have to sign a screening ICF (screening criterion n°3 is not applicable), and for non-screening criterion n°5, the 3-month wash-out period is prior to the inclusion visit in the treatment phase. Subject

Inclusion Criteria:

1. Patients who still meet all the

Eligibility Criteria:

1. checked at screening visit.
2. Patients who have untreated PCa with a Gleason score of 7 (preferably) or higher, with local disease or with metastatic disease (if metastatic, no visceral metastases, no more than five bone or lymph node metastases), and are scheduled to undergo RPE about 3 weeks later.
3. Patients with an expected minimal survival time of 12 months.
4. Patients who have an acceptable organ and marrow function as assessed at the inclusion visit and defined as follows:
5. Absolute neutrophil count ≥ 1.5 × 109/L.
6. Platelets ≥ 100 × 109/L.
7. Hemoglobin ≥ 9 g/dL.
8. Total bilirubin ≤ 1.5 × ULN, unless the patient has known Gilbert's syndrome.
9. Aspartate amino transferase (AST) and alanine amino transferase (ALT) ≤ 2.5 × ULN or ≤ 5 × ULN in presence of liver metastasis.
10. Serum creatinine ≤ 2.0 × ULN, or GFR ≥ 30 mL/min by Cockcroft-Gault.
11. INR <1.5, aPTT < 60 s
12. Patients with an ECOG performance status ≤
13. Patients who agree to refrain to donate sperm for the duration of the study.
14. Patients who signed a written treatment phase ICF.

View trial on ClinicalTrials.gov