Teverelix Evaluated in Advanced Prostate Cancer (NCT04693507) | Clinical Trial Compass
CompletedPhase 2
Teverelix Evaluated in Advanced Prostate Cancer
Lithuania50 participantsStarted 2021-03-04
Plain-language summary
The purpose of this study is to assess the safety and efficacy of teverelix TFA in the treatment of advanced prostate cancer
Who can participate
Age range18 Years – 80 Years
SexMALE
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Inclusion Criteria:
* Is male, aged ≤80 years (≥18 years) at the beginning of the treatment period (Day 0)
* Has histologically proven advanced adenocarcinoma of the prostate (metastatic or non metastatic hormone-sensitive non curative), suitable for ADT
* Is treatment naïve for any of the following: a. GnRH analogues b. Androgen receptor antagonists, or c. Androgen synthesis inhibitors (e.g. abiraterone)
* Agrees to practice contraception during the entire study treatment period and for 3 months after the last dose of IMP is administered: a. Either by using double barrier contraception, b. or, is truly sexually abstinent, when this is in line with the preferred and usual lifestyle of the participant
* Has provided written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed a part of his normal medical care
Exclusion Criteria:
* 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 \[ALAT/SGPT\]), or total bilirubin exceeding twice the upper limit of the normal (ULN) range b. Creatinine twice the ULN range c. Uncontrolled diabetes (HbA1c \>7.5%) or previously undiagnosed diabetes mellitus with HbA1c \>6.5%
* Has any contraindication to the use of teverelix TFA
* Has life expectanc…