The purpose of this clinical trial is to test the effectiveness of a dosing regimen of Teverelix DP castration rate defined as the cumulative probability of testosterone suppression to \< 0.5 ng/mL with the lower bound of the 95% confidence interval (CI) being \> 90% to meet the evaluation criteria for efficacy.
The main question it aims to answer is:
•Is the dosing regimen of Teverelix DP in this study effective at achieving the required testosterone suppression to castrate levels.
Participants will
* Receive a single loading dose consisting of 3 injections of teverelix DP (180 mg IM + 2x 180 mg SC) on Day 1. * Receive a maintenance dose consisting of 2 injections (2X 180 mg SC) from week 4 (Day 29) and every 6 weeks up to Week 16 (Day 113). * The first 30 enrolled participants will have 24-hour continuous Holter monitoring performed and 24-hour PK samples will be drawn.
The results of this study are intended to support dose selection and provide supportive safety and PK/PD data to enable advancement into a subsequent Phase 3 clinical study in patients with advanced prostate cancer who are at high cardiovascular risk.
Is male, aged ≤85 years (≥18 years) at the beginning of the treatment period (Day 1)
Has histologically proven advanced adenocarcinoma of the prostate (metastatic or non metastatic, hormone-sensitive, non-curative), suitable for androgen deprivation therapy
Is treatment naïve for GnRH analogues
Either by using double barrier contraception,
Liver function test (aspartate aminotransferase [ASAT/SGOT], alanine aminotransferase [ALAT/SGPT]), exceeding >2X the ULN range
Total bilirubin exceeding >1.5X the ULN range
Creatinine twice the ULN range
Uncontrolled diabetes (HbA1c >7.5%) or previously undiagnosed diabetes mellitus with HbA1c >6.5%