Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic … (NCT04666129) | Clinical Trial Compass
CompletedPhase 1
Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer
United States48 participantsStarted 2021-02-18
Plain-language summary
This study is being conducted to assess the safety and tolerability of relugolix with other agents approved for use in combination with androgen deprivation therapy (ADT) for a 12-week treatment period and an additional 40-week safety extension period in men with prostate cancer, either metastatic castration-sensitive prostate cancer (mCSPC) or non-metastatic or metastatic castration-resistant prostate cancer (nmCRPC or mCRPC).
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. A previous diagnosis of adenocarcinoma of the prostate confirmed by histologic or cytologic evidence and with a documented medical history of either:
✓. Initiating treatment or currently receiving treatment of leuprolide acetate (3-, 4-, or 6-month injections \[intramuscular Lupron or subcutaneous Eligard\]) or another GnRH receptor agonist (triptorelin) or a GnRH receptor antagonist (degarelix or relugolix \[maximum duration of 3 months\]) in combination with:
Exclusion criteria
✕. A medical history of brain or hepatic metastases based on radiologic evidence or a medical history of surgical castration;
✕. Received combination treatment with a GnRH analog or GnRH receptor antagonist with either abiraterone acetate plus a corticosteroid (Part 1) or apalutamide (Part 2) in patients with mCSPC (Part 1 and Part 2) or nmCRPC (Part 2) for a total duration \> 24 months or in patients with mCRPC (Part 1) for a total duration \> 6 months;
✕. Is scheduled or anticipates being scheduled for major surgery during the study treatment period;
✕. A current diagnosis of a malignancy other than prostate cancer, with the exception of any of the following:
. Abnormal clinical laboratory test value(s) at the screening visit or prior to the baseline (Day 1) visit including:
✕. Known hepatic disease, including alcoholic liver disease or viral hepatitis such as hepatitis A (hepatitis A virus IgM positive), chronic hepatitis B (HbsAg positive), or chronic hepatitis C (HCV antibody positive, confirmed by HCV RNA) or clinical signs of hepatic disease such as jaundice;
✕. A medical history within 6 months prior to the screening visit or a current diagnosis of any of the following: