advanced hormone-sensitive prostate cancer
Conditions
Interventions
Test Group:Relugolix Tablets
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Before starting any screening or study specific procedures, voluntarily signed the informed consent form and indicated its date. (2) Male, aged >= 18 years; (3) Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma; (4) Has androgen-sensitive advanced prostate cancer, and in the opinion of the investigator, and need at least 24 weeks of continuous androgen deprivation therapy, with one of the following clinical disease state or presentations: a. evidence of biochemical (PSA) or clinical relapse (imaging) following local primary intervention with curative intent, such as surgery, radiation therapy, cryotherapy, or high-frequency ultrasound, and not a candidate for salvage treatment by surgery; b. newly diagnosed with androgen-sensitive metastatic disease; c. advanced localized disease unlikely to be cured by local primary intervention with either surgery or radiation with curative intent; (5) At the Screening visit, serum testosterone levels should be >= 150 ng/dL (1.50 ng/mL or 5.2 nmol/L); (6) At the Screening visit, serum PSA levels should be > 2.0 ng/dL (2.0 µg/L), or if applicable, post radical prostatectomy of > 0.2 ng/mL (0.2 µg/L); (7) Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. (8) Subject with fertility (including his partner) agrees to take effective contraceptive measures throughout the study period and for 4 months after the final dose of study medication.
Exclusion criteria
Exclusion criteria: (1) According to previous clinical evaluations or imaging findings, there is a presence of brain metastasis. (2) Has active malignant diseases other than prostate cancer and the following diseases: a. fully treated basal cell carcinoma, squamous cell carcinoma of the skin, or any type of carcinoma in situ; b. fully treated stage I cancer, the subject is currently in remission (complete or partial remission) and has been in remission for = 2 years; c. any other form of cancer with a disease-free period (continuous recurrence free time) of = 5 years; (3) Within 6 months (180 days) prior to the first day of baseline, any of the following conditions occurred: myocardial infarction; unstable angina; unstable symptomatic ischemic heart disease; New York Heart Association (NYHA) Grade III or IV heart failure; thromboembolic events (such as deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events); any other serious cardiac disease (such as pericardial effusion, restrictive cardiomyopathy, severe untreated valve stenosis, or severe congenital heart disease); (4) Known to have gastrointestinal diseases that can interfere with the oral absorption or tolerance of Relugolix Tablets, or have undergone related surgeries (excluding appendectomy and rectectomy), including diseases that cannot be swallowed whole or may interfere with small intestine absorption. This type of disease or surgery includes but is not limited to Crohn's disease, gastric bypass surgery, active peptic ulcer disease, and gastrectomy. (5) During the trial period, scheduled major surgeries (such as radical prostatectomy, nephrectomy, liver transplantation, etc.) will be performed. (6) Has a history of anaphylaxis, or has known to have contraindications or hypersensitivity history to the study drug or its excipients (mannitol, carboxymethyl starch sodium, hydroxypropyl cellulose, magnesium stearate). (7) Abnormal laboratory values during screening visits may indicate clinically unstable underlying diseases or the following laboratory values: a. Serum gamma glutamyl transferase >2.0 × upper limit of normal (ULN). b. Serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2.5 × ULN (for those with liver metastasis, ALT and/or AST>5 × ULN). c. Total bilirubin > 1.5 × ULN (unless secondary to Gilbert syndrome or consistent with the diagnosis of Gilbert syndrome). d. Serum creatinine>1.5 × ULN. e. Platelet count10%, or that of diabetes patients not previously diagnosed is>8%. (9) Has Jaundice or current active liver disease known to be caused by any reason, including hepatitis B (hepatitis B virus surface antigen [HBsAg] positive and hepatitis B virus DNA test result positive) or hepatitis C (hepatitis C virus [HCV] antibody positive). (10) Known to have a human immunodeficiency virus infection, or tested positive for HIV. (11) Has Significant abnormalities in electrocardiogram (ECG) during screening visit, such as heart rate470ms), or is using drugs that may prolong the QTcF interval, or has congenital long QT syndrome. (12) Despite receiving appropriate medical treatment, hypertension remains uncontrolled (systolic blood pressure = 160 m
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained Castration Rate of Serum Testosterone; | — |
Secondary
| Measure | Time frame |
|---|---|
| Castration Rate;Profound Castration Rate;Proportion of Patients with Confirmed Prostate Specific Antigen Response;Time to Prostate Specific Antigen Progression;Proportion of Patients with Prostate Specific Antigen Progression in Those Who Reached Testosterone Sustained Suppression during 24 Weeks’ Treatment Period;Endocrine Pharmacologic Parameters’ Change at Each Scheduled Visit after Treatment from Baseline;Imaging Assessment: Changes in Tumor Size and Metastasis Relative to Baseline at Each Scheduled Visit Time after Administration, Objective Response Rate, and Clinical Benefit Rate.;Subject's Questionnaire;Survival Rate;Safety Evaluation Indicators: Adverse Events, Weight, Body Mass Index, Vital Signs, Physical Examination, Laboratory Tests, 12 Lead Electrocardiogram + QTcF and Other Indicators; | — |
Countries
China
Contacts
Public ContactNianzeng Xing
Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed