Overview

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

Status:
Recruiting
Trial end date:
2021-10-25
Target enrollment:
0
Participant gender:
Male
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Treatments:
Abiraterone Acetate
Criteria
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.