Comparative Study of Abiraterone Acetate Tablets (I) or ZYTIGA® in Patients With Metastatic Castration-resistant Prostate Cancer
Phase 2
Completed
- Conditions
- Metastatic Castration-resistant Prostate Cancer (mCRPC)
- Interventions
- Registration Number
- NCT04862091
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 69
Inclusion Criteria
- Males, ≥ 18 years old;
- 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);
- 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;
- 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);
- ECOG performance status score of ≤ 1;
- Life expectancy of ≥ 6 months;
- Major organs are functioning well
Exclusion Criteria
- History of pituitary or adrenal dysfunction;
- 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;
- 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);
- 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;
- 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;
- 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);
- With contraindications to the use of glucocorticoids, such as uncontrolled persistent infections or other conditions;
- 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;
- 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;
- 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;
- Inability to swallow the whole tablet;
- Other conditions that make the patient unsuitable for the study as judged by the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ZYTIGA®. ZYTIGA® - Abiraterone Acetate Tablets (I) Abiraterone Acetate Tablets (I) -
- Primary Outcome Measures
Name Time Method Serum testosterone concentration Day 9/Day 10 Blood Sample tested for Serum Testosterone Levels
- Secondary Outcome Measures
Name Time Method Cmin, ss Day 9 Defined as the steady-state minimum concentration
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
Cav, ss Day 9 Defined as the mean blood drug concentration during the dosing interval at steady state
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
Cmax, ss Day 9 Defined as the steady-state maximum concentration
Trial Locations
- Locations (1)
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China