Metastatic Castration-resistant Prostate Cancer (mCRPC)
Conditions
Brief summary
To evaluate whether the efficacy of the abiraterone acetate tablets (I) is comparable to that of the ZYTIGA®) by comparing the serum testosterone concentrations on Day 9 and/or Day 10 after oral administration of the two formulations in patients with metastatic castration-resistant prostate cancer (mCRPC).
Interventions
DRUGAbiraterone Acetate Tablets (I)
Abiraterone Acetate Tablets (I)
DRUGZYTIGA®
ZYTIGA®
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Abiraterone Acetate Tablets (I) compared with ZYTIGA®
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males, ≥ 18 years old; 2. Histologically or cytologically diagnosed with prostate adenocarcinoma, without neuroendocrine or small cell characteristics, and having metastatic lesions with imaging evidence (such as positive bone scan or metastatic lesions on CT/MRI); 3. Serum testosterone level \< 50 ng/dL or 1.7 nmol/L at the screening; subjects who have not undergone bilateral orchidectomy must plan to continue medication throughout the study to maintain therapy with effective GnRH agonist or antagonist; 4. Progression of prostate cancer as confirmed by diagnostic files, meeting one of the conditions for disease progression: 1) Biochemistry evidence of recurrence: continuous 3 rises of PSA (taken a minimum of 1 week apart) from a baseline measurement of at least 2 ng/mL, greater than 50% of the minimum value in 2 rises; 2) Radiographic progression: a clear evidence of new lesion; 2 or more new bone lesions appearing on bone scan; CT or MRI showing lesion progression (RECIST 1.1); 5. ECOG performance status score of ≤ 1; 6. Life expectancy of ≥ 6 months; 7. Major organs are functioning well
Exclusion criteria
1. History of pituitary or adrenal dysfunction; 2. Have used flutamide within 4 weeks before the first dose of study treatment, and bicalutamide or nilutamide within 6 weeks before the first dose of study treatment; 3. Prior therapy with CYP17 inhibitors (such as abiraterone acetate, ketoconazole, TAK-700, etc.) or investigational drugs or marketed drugs of new androgen receptor antagonists (such as enzalutamide, apalutamide, SHR3680, ODM-201, and proxalutamide); 4. Have received 5-reductase inhibitors (such as finasteride and dutasteride), estrogen, progesterone, any herbal products (such as saw palmetto) that may decrease PSA levels, and radiotherapy within 4 weeks prior to the start of study medication; 5. Have previously received biotherapy or cytotoxic chemotherapy for mCRPC; patients who have completed docetaxel treatment for at least 1 year before enrollment can participate in screening; 6. Prostate cancer with moderate to severe pain symptoms, with a score of \> 3 for Question 3 (the worst pain in the last 24 hours, 0-1 point means asymptomatic, 2-3 points mean mild symptoms) of the Brief Pain Inventory-Short Form (BPI-SF); 7. With contraindications to the use of glucocorticoids, such as uncontrolled persistent infections or other conditions; 8. Chronic diseases that require systemic corticosteroid therapy (\> 10 mg/day prednisone or equivalent). Patients who have discontinued the administration or reduced the dose to \< 10 mg within 14 days prior to the start of study treatment are eligible; 9. Presence of abdominal fistula, gastrointestinal perforation, abdominal abscess, or other abnormal gastrointestinal function within 6 months before the first dose of study treatment, which may affect drug absorption as judged by the investigator; 10. Presence of active heart disease within 6 months prior to the first dose of study treatment, including: severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, left ventricular ejection fraction \< 50%, and severe arrhythmia requiring treatment or New York Heart Association (NYHA) Class III-IV heart failure; 11. Inability to swallow the whole tablet; 12. Other conditions that make the patient unsuitable for the study as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum testosterone concentration | Day 9/Day 10 | Blood Sample tested for Serum Testosterone Levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PSA-50 response rate | Day 28, Day 56, and Day 84 | The percentage of subjects with total serum PSA level decreased by 50% from the baseline value. |
| Absolute testosterone concentration | Day 9/10, Day 28, Day 56, and Day 84 | The actual measured serum testosterone concentration. |
| Testosterone inhibition rate | Day 9/10, Day 28, Day 56, and Day 84 | The percentage of subjects with a serum testosterone concentration of ≤ 1 ng/dL |
| Steady-state minimum concentration of abiraterone | Day 9/10, Day 28, Day 56, and Day 84 | Defined as the plasma concentration of abiraterone |
| PSA level | Day 28, Day 56, and Day 84 | The serum total PSA level |
| AUC0-τ | Day 9 | Defined as the area under the curve within the dosing interval at steady state |
| Cmin, ss | Day 9 | Defined as the steady-state minimum concentration |
| Cav, ss | Day 9 | Defined as the mean blood drug concentration during the dosing interval at steady state |
| Cmax, ss | Day 9 | Defined as the steady-state maximum concentration |
Countries
China
Outcome results
None listed