advanced prostate cancer
Conditions
Interventions
Test Product
Relugolix 120 mg tablet strength will be available as immediate-release
film-coated tablets, and 1 tablet (120 mg) will be administered once daily
following an oral loading dose of 360
Sponsors
Myovant Sciences Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Has voluntarily signed and dated the informed consent form prior to initiation of any screening or study-specific procedures; 2. Is a male aged 18 years or older on the day of signing and dating the informed consent form; 3. Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate; 4. Is a candidate for, in the opinion of the investigator, at least 1 year of continuous androgen deprivation therapy for the management of androgen-sensitive advanced prostate cancer with one of the following clinical disease state presentations: a. Evidence of biochemical (PSA) or clinical relapse 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 (radiotherapy, cryotherapy, or high frequency ultrasound are allowed after 2 months of androgen deprivation therapy); or b. Newly diagnosed androgen-sensitive metastatic disease; or c. Advanced localized disease unlikely to be cured by - local primary surgical intervention with either surgery or radiation with curative intent (radiotherapy, cryotherapy, or high frequency ultrasound are allowed after 2 months of androgen deprivation therapy); 5. Has a serum testosterone at the Screening visit of >= 150 ng/dL (1.5 ng/mL of 5.2 nmol/L); 6. Has a serum PSA concentration at the Screening visit of > 2.0 ng/mL (2.0 µg/L), or, when applicable, post radical prostatectomy of > 0.2 ng/mL (0.2 µg/L) or post radiotherapy, cryotherapy, or high frequency ultrasound > 2.0 ng/mL (2.0 µg/L) above the post interventional nadir; 7. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at initial screening and at baseline; 8. Is a male patient who, even if surgically sterilized (ie, status post vasectomy): a. Agrees to use a male condom if having sex with a woman of childbearing potential or a pregnant woman, during the entire study Treatment Period and through 4 months after the last dose of study drug; or b. Agrees to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods for the female partner) and withdrawal are not acceptable methods of contraception; 9. Must agree not to donate sperm from first dose of study drug through 4 months after the last dose of study drug; 10. A randomization authorization form has been signed by a study medical monitor approving the patient for randomization into the trial.
Exclusion criteria
Exclusion criteria: 1. In the investigator's opinion, is likely to require chemotherapy or surgical therapy for symptomatic disease management within 2 months of initiating androgen deprivation therapy; 2. Previously received GnRH analog or other form of androgen deprivation therapy (estrogen or antiandrogen) for > 18 months total duration. If androgen deprivation therapy was received for = 2 years; any other cancer from which the subject has been disease-free for >= 5 years; 8. Abnormal laboratory values at the Screening visit that suggest a clinically unstable underlying disease, or the following laboratory values: a. Serum gamma-glutamyl transferase > 2.0 x upper limit of normal (ULN); b. Serum ALT and/or AST > 1.0 x ULN; c. Total Bil. > 1.0 x ULN (unless secondary to Gilbert's syndrome or the pattern is consistent with a diagnosis of Gilbert's syndrome) or; d. Serum creatinine > 2.0 mg/dL (176.8 µmol/L); e. Platelets 10% in patients previously diagnosed with diabetes. HbA1c > 8% in patients whose diabetes is previously undiagnosed. (Excluded patients may be rescreened after referral and evidence of improved control of their condition); 10. Has jaundice or known current active liver disease from any cause, including hep. A (hep. A virus IgM positive), hep. B (hep. B virus surface antigen [HBsAg] positive), or hep. C (hep. C virus [HCV] antibody positive, confirmed by HCV ribonucleic acid); 11. Known human HIV infection; 12. Any of the following within 6 months before Baseline Day1: a. myocardial infarction b. unstable angina c. unstable symptomatic ischemic heart disease d. NYHA class 3 or 4 heart failure e. Thromboembolic events (deep vein thrombosis, pulmonary embolism, symptomatic cerebrovascular events) f. Any other significant cardiac condition (pericardial effusion, restrictive cardiomyopathy, severe untreated valvular stenosis, severe congenital heart disease); 13. These ECG abnormalities are excluded: a. ECG evidence of ischaemia b. Q-wave infarction, unless identified 6 or more months before the Screen visit; c. QTc > 470 msec, measured by Fridericia's formula [QTcF = QT/(RR^0.33)]. If the QTc is prolonged in a patient with a pacemaker, the patient may be enrolled in the study if confirmed by the medical monitor. d. Congenital long QT syndrome. e. Active conduction system abnormalities, e.g., • Mobitz II second deg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained castration rate defined as the cumulative probability of testosterone suppression to | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints • Describe effects on serum testosterone: o Castration rate defined as the cumulative probability of testosterone suppression to | — |
Countries
Netherlands
Outcome results
None listed