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

NCT04862091 | Completed Phase 2 FDA Drug

• 1 other identifier: ABTL-PD-01
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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).

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Outcome Measures

Primary Outcomes (1)

• Serum testosterone concentration

  Blood Sample tested for Serum Testosterone Levels

  Day 9/Day 10

Secondary Outcomes (9)

• PSA level

  Day 28, Day 56, and Day 84

• PSA-50 response rate

  Day 28, Day 56, and Day 84

• Absolute testosterone concentration

  Day 9/10, Day 28, Day 56, and Day 84

• Testosterone inhibition rate

  Day 9/10, Day 28, Day 56, and Day 84

• Steady-state minimum concentration of abiraterone

  Day 9/10, Day 28, Day 56, and Day 84

Study Arms (2)

Abiraterone Acetate Tablets (I)

EXPERIMENTAL

Drug: Abiraterone Acetate Tablets (I)

ZYTIGA®.

ACTIVE COMPARATOR

Drug: ZYTIGA®

Interventions

Abiraterone Acetate Tablets (I) DRUG

Abiraterone Acetate Tablets (I)

Abiraterone Acetate Tablets (I)

ZYTIGA® DRUG

ZYTIGA®

ZYTIGA®.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (1)

• Lu X, Dai T, Chen X, Wu B, Chen H, Wu J, Yu D, Ge H, Li J, Huang H, Fan T, Cheng L, Zhang X, Zhang X, Yao X, Wei J, Xu Z, Yang W, He C, Luo J, Guan L, Fu B, Wang Q, Chen X, Zhang Y, Shi B, Zheng B, Wang Y, Luo H, Chen G, Wang H, Wang Q, Ye D. A randomized, open-label, multi-center, active-controlled phase II study comparing abiraterone acetate tablets (II), an improved formulation, versus originator abiraterone acetate in patients with metastatic castration-resistant prostate cancer. BMC Med. 2025 May 9;23(1):271. doi: 10.1186/s12916-025-04053-7.

  PMID: 40346626 DERIVED

MeSH Terms

Interventions

Abiraterone Acetate

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Abiraterone Acetate Tablets (I) compared with ZYTIGA®

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: April 27, 2021
• Study Start: April 23, 2021
• Primary Completion: October 21, 2021
• Study Completion: January 6, 2022
• Last Updated: March 4, 2022

Record last verified: 2021-04

Locations

CN (1)