A Study of Abiraterone Acetate in Metastatic Castration-Resistant Prostate Cancer Participants Who Responded Poorly to the First-line Combined Androgen Blockade Therapy

NCT02405858 | Completed Phase 4 DMC

• 2 other identifiers: CR106841ABI-C-14-JP-001-V03
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of this study is to evaluate the percentage of participants achieving prostate-specific antigen (PSA) response by 12 weeks of therapy from baseline according to Prostate Cancer Clinical Trials Working Group (PCWG2) criteria.

Conditions

Metastatic Castration-Resistant Prostate Cancer

Keywords

Metastatic Castration-Resistant Prostate Cancer; Abiraterone Acetate; ZYTIGA; Prednisolone

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Prostate-specific Antigen (PSA) Response (PSA Response Rate) by 12 Weeks of Therapy

  A PSA response is defined as the first occurrence of greater than or equal to (\>=) 50 percent (%) decrease from baseline by 12 weeks after the first dose of study drug, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after the initial documentation.

  up to 2 years

Secondary Outcomes (11)

• Duration of PSA Response

  Up to 2 years

• Time to PSA Response

  Up to 2 years

• Percentage of Participants Achieving PSA Response by 24 weeks of Therapy

  Up to 2 years

• PSA-based Progression-free Survival (PSA-PFS)

  Time from randomization up to radiographic progression, clinical progression or death, whichever occurs first (maximum up to 2 years)

• Maximum Serum PSA Decline Evaluation

  Baseline and Day 1 of each cycle up to 2 years

Study Arms (1)

Abiraterone Acetate

EXPERIMENTAL

Participants will receive abiraterone acetate 1000 milligram (mg) (four 250 mg tablets) orally once daily, concomitantly with oral prednisolone 10 mg per day. No food should be consumed for at least 2 hours before the dose of abiraterone acetate is taken and for at least one hour after the dose of abiraterone acetate is taken. A 28-daily dosing cycle will continue until disease progression or unacceptable toxicity is observed up to 2 years.

Drug: Abiraterone Acetate; Drug: Prednisolone

Interventions

Abiraterone Acetate DRUG

Abiraterone acetate 1000 milligram (mg) (four 250 mg tablets) orally once daily up to Cycle 26.

Also known as: ZYTIGA

Abiraterone Acetate

Prednisolone DRUG

Oral prednisolone 5 mg will be concomitantly administered twice a day (10 mg/day) up to Cycle 26.

Abiraterone Acetate

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who have histologically or cytologically confirm adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
• Participants who had prostate-specific antigen (PSA) progression defined as a rise of PSA at least 1 week apart resulting in 25 percent (%) increase in PSA with last PSA greater than (\>) 2 nanogram per milliliter (ng/mL) (according to PCWG2) after antiandrogen withdrawal
• Participants who had PSA progression within a year after the start of first-line CAB therapy, or who had PSA progression without having a normal PSA level (less than \[\<\] 4.0 ng/mL) in the first-line combined androgen blockade (CAB) therapy
• Participants who have not been treated with cytotoxic chemotherapy (including estramustine) for the treatment of prostate cancer (neoadjuvant or adjuvant chemotherapy is only allowed if the last dose is greater than or equal to \[\>=\] 1 year from the scheduled date of initial administration of abiraterone acetate)
• Participants who have target or non-target metastatic abnormalities either on screening bone scan, computed tomography (CT) or magnetic resonance imaging (MRI)

You may not qualify if:

• A participant who has known allergies, hypersensitivity, or intolerance to abiraterone acetate or its excipients
• A participant who has severe liver dysfunction (Child-Pugh Score C), active or symptomatic viral hepatitis or chronic liver disease
• A participant who has received other hormonal therapy, including any dose of finasteride, dutasteride, any herbal product known to decrease PSA levels (example: Saw Palmetto and PC-SPES) within 4 weeks prior to the scheduled date of initial administration of abiraterone acetate
• A participant who has had surgery or local prostatic intervention within 4 weeks prior to the scheduled date of initial administration of abiraterone acetate
• A participant who has active infection or other medical condition that would make prednisolone use contraindicated

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (14)

Unknown Facility

Asahi, Japan

Location

Unknown Facility

Higashi-Ibaraki, Japan

Location

Unknown Facility

Kanazawa, Japan

Location

Unknown Facility

Kobe, Japan

Location

Unknown Facility

Koshigaya, Japan

Location

Unknown Facility

Kumamoto, Japan

Location

Unknown Facility

Narashino, Japan

Location

Unknown Facility

Okayama, Japan

Location

Unknown Facility

Sagamihara, Japan

Location

Unknown Facility

Sakura, Japan

Location

Unknown Facility

Shinjuku-Ku, Japan

Location

Unknown Facility

Sunto, Japan

Location

Unknown Facility

Yokohama, Japan

Location

Unknown Facility

Yokosuka, Japan

Location

Related Links

• A Phase 4 Study of Abiraterone Acetate in Metastatic Castration-Resistant Prostate Cancer Patients Who Poorly Responded to the First-line Combined Androgen Blockade Therapy

MeSH Terms

Interventions

Abiraterone Acetate; Prednisolone

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2015
• First Posted: April 1, 2015
• Study Start: April 10, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

JP (14)