Health Condition 1: N428- Other specified disorders of prostate
Conditions
Interventions
Intervention1: Relugolix tablet 120 mg: Patients will be dispensed marketed blister pack of Relugolix tablet 120 mg.
Patients will be advised to take oral loading dose of Relugolix 360 mg (3 x 120-mg
Sponsors
Zydus Lifesciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male patients of 18 to 85 years of age (both inclusive) with a documented diagnosis of advanced prostate cancer. 2. Patients have a serum testosterone at the screening visit of greater than equal to 150 ng per dL 3. Patient with serum PSA concentration at the screening visit of greater than 2.0 ng per mL or when applicable post radical prostatectomy of greater than 0.2 ng per mL 4. Life expectancy of at least 6 months from screening 5. Patients willing to provide written informed consent and comply with the protocol requirements
Exclusion criteria
Exclusion criteria: 1. In the investigator opinion, is likely to require chemotherapy or surgical therapy for symptomatic disease management within 2 months of initiating androgen deprivation therapy. 2. Previously received gonadotropin-releasing hormone analog (GnRH analog) or other form of androgen deprivation therapy (estrogen or antiandrogen) for greater than 18 months total duration. If androgen deprivation therapy was received for less than equal to 18 months total duration, then prior androgen deprivation therapy must have been completed at least as long as the dosing interval of the depot. 3. Metastases to brain as per prior clinical evaluation. 4. History of surgical castration 5. Patients with myocardial infarction, uncontrolled hypertension, unstable symptomatic ischemic heart disease, cerebrovascular events, or any significant cardiac condition within the prior 6 months. 6. Patients with clinically significant uncontrolled systemic diseases such as renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy other than prostate 7. Patients with hepatic dysfunction (serum transaminases greater than equal to 3 times of Upper Normal Limit) or renal dysfunction (serum creatinine greater than equal to 2.5 mg per dl) at screening 8. Patients with continuing history of alcohol or drug abuse 9. Participation in another clinical trial within 3 months prior to screening 10. Any other reason for which the investigator feels that the patient should not participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieved sustained testosterone suppression to castrate levels (less than 50 ng per dL)Timepoint: At 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Proportion of patients achieved castrate level 2.Proportion of patients achieved profound castrate levels (less than 20 ng per dL) 3.Proportion of patients achieved greater than equal to 50% reduction in PSA 4.Adverse events reported during the study 5.Serious adverse events reported during the studyTimepoint: 1.At week 2 and week 6 visit. 2.At week 2, week 6 and week 12 visit. 3.From baseline at week 2, week 6 and week 12 visit. 4.AE and SAE reported during the study | — |
Countries
India
Contacts
Public ContactDr Nidhi Singh
Zydus Healthcare Ltd.
Outcome results
None listed