The purpose of this study is to assess the safety and efficacy of teverelix TFA in the
treatment of advanced prostate cancer
After being informed about the study and potential risks, all patients giving written
informed consent will undergo an up to 7 day screening period to determine eligibility for
study entry. On Day 0, patients who meet the eligibility requirements will be enrolled in an
open-label manner and will receive a loading dose of teverelix TFA (one subcutaneous (SC)
injection in the abdomen and one intramuscular (IM) injection in the buttock). Patients will
then receive maintenance doses of teverelix TFA (one SC injection in the abdomen) at 4- or
6-weekly intervals up to week 24. The patients will return for a final assessment 4 weeks
after their last maintenance dose injection.
The initial dosing regimen to be tested (Group 1) is:
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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