TEVERELIX for Advanced prostate cancer

Inclusion criteria

• {"criterion_text":"- (1) Is male, aged ≤85 years (≥18 years) at the beginning of the treatment period (Day 1)\n- (2) Has histologically proven advanced adenocarcinoma of the prostate (metastatic or non- metastatic, hormone-sensitive, non-curative), suitable for androgen deprivation therapy\n- (3) Is treatment naïve for GnRH analogues"}

Exclusion criteria

• {"criterion_text":"- (1) Has abnormal screening and/or baseline laboratory values that suggest a clinically significant underlying disease, or the following laboratory values: (a) Liver function test (aspartate aminotransferase [ASAT/SGOT], alanine aminotransferase [ALAT/SGPT]), exceeding >2X the upper limit of the normal (ULN) range (b) Total bilirubin exceeding >1.5X the upper limit of the normal (ULN) range (c) Creatinine twice the ULN range (d) Uncontrolled diabetes (HbA1c >7.5%) or previously undiagnosed diabetes mellitus with HbA1c >6.5% (e) An estimated glomerular filtration rate (eGFR) < 30 mL/min, based on creatinine clearance calculation by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation normalized to an average surface area of 1.73m2, at the screening visit.\n- (2) Has any contraindication to the use of teverelix DP\n- (3) Has a life expectancy of less than 1 year\n- (4) Has T levels <1.5 ng/mL at screening\n- (5) Has a medical history of bilateral orchidectomy"}

Primary endpoints

• {"endpoint_text":"- The sustained castration rate defined as the cumulative probability of achieving testosterone suppression to castrate levels of ≤ 0.5 ng/mL (1.7 nmol/L) while on study treatment from Study Day 29 through Study Day 155","definition_or_measurement_approach":"Cumulative probability of achieving testosterone suppression to ≤ 0.5 ng/mL (1.7 nmol/L) while on study treatment from Study Day 29 through Study Day 155"}

Secondary endpoints

• {"endpoint_text":"- The sustained castration rate, defined as the cumulative probability of testosterone suppression to ≤ 0.2 ng/mL (0.7 nmol/L) while on study treatment from Study Day 29 through Study Day 155","definition_or_measurement_approach":"Cumulative probability of testosterone suppression to ≤ 0.2 ng/mL (0.7 nmol/L) while on study treatment from Study Day 29 through Study Day 155"}

Lithuania

Earliest CTIS Part Ii Submission Date

04-04-2024

Latest Decision Or Authorization Date

21-01-2026

Processing Time Days

657

Number Of Sites

4

Number Of Participants

44

Primary sponsor

Full Name

Antev Limited

Organisation Type

Pharmaceutical company

Country Of Registered Address

United Kingdom

Co-sponsors

• Antev Nordic AB