Comparative Study of Abiraterone Acetate Tablets (I) or ZYTIGA® in Patients With Metastatic Castration-resistant Prostate Cancer

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®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04862091
• Other study ID #: ABTL-PD-01
• Status: Completed
• Phase: Phase 2
• Start date: April 23, 2021
• Est. completion date: January 6, 2022

Study information

• Verified date: April 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Metastatic Castration-resistant Prostate Cancer (mCRPC)
• Prostatic Neoplasms

Intervention

Drug:
• Abiraterone Acetate Tablets (I)
Abiraterone Acetate Tablets (I)
• ZYTIGA®
ZYTIGA®

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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