Metastatic Castration-resistant Prostate Cancer (mCRPC) Clinical Trial
Official title:
A Randomized, Open-Label, Multi-Center, Parallel Controlled Study Comparing the Serum Testosterone Levels in Patients With Metastatic Castration-Resistant Prostate Cancer After Oral Administration of Abiraterone Acetate Tablets (I) or ZYTIGA®
Verified date | April 2021 |
Source | Jiangsu HengRui Medicine Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 69 |
Est. completion date | January 6, 2022 |
Est. primary completion date | October 21, 2021 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Fudan University Shanghai Cancer Center | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Jiangsu HengRui Medicine Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum testosterone concentration | Blood Sample tested for Serum Testosterone Levels | Day 9/Day 10 | |
Secondary | PSA level | The serum total PSA level | Day 28, Day 56, and Day 84 | |
Secondary | PSA-50 response rate | The percentage of subjects with total serum PSA level decreased by 50% from the baseline value. | Day 28, Day 56, and Day 84 | |
Secondary | Absolute testosterone concentration | The actual measured serum testosterone concentration. | Day 9/10, Day 28, Day 56, and Day 84 | |
Secondary | Testosterone inhibition rate | The percentage of subjects with a serum testosterone concentration of = 1 ng/dL | Day 9/10, Day 28, Day 56, and Day 84 | |
Secondary | Steady-state minimum concentration of abiraterone | Defined as the plasma concentration of abiraterone | Day 9/10, Day 28, Day 56, and Day 84 | |
Secondary | Cmax, ss | Defined as the steady-state maximum concentration | Day 9 | |
Secondary | AUC0-t | Defined as the area under the curve within the dosing interval at steady state | Day 9 | |
Secondary | Cmin, ss | Defined as the steady-state minimum concentration | Day 9 | |
Secondary | Cav, ss | Defined as the mean blood drug concentration during the dosing interval at steady state | Day 9 |
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