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%
Single group
Teverelix DP 180 mg
DrugTeverelix DP 540 mg Day 1 and 360 mg every 6 weeks from week 4 to week 16.
To evaluate the efficacy of a dosing regimen of teverelix DP in attaining by Day 29 and sustaining to Day 155 castration rate
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%
Evaluate the safety of teverelix DP through the incidence of adverse events.
Evaluate the safety of teverelix DP through the incidence of abnormalities in clinical laboratory data
Evaluate the safety of teverelix DP by assessing QTc-teverelix DP plasma concentration relationship via 24-hour ECG Holter data collected in a subset of patients (n=30)
Evaluate the change in Prostate Specific Antigen (PSA)
Characterise the effect of teverelix DP on pharmacodynamic parameters total T, LH and FSH in 40 patients
Define PK parameters for teverelix DP by maximum observed plasma concentration (Cmax) of teverelix DP
Define PK parameters for teverelix DP by area under the concentration-time curve (AUC0-τ) of teverelix DP
This trial is not recruiting at the moment. You can still explore other options:
