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

Janssen Pharmaceutical K.K.51 enrolled

Overview

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.

This is a Phase 4, non-randomized, multi-center (when more than one hospital work on a medical research study), open label (identity of study drug will be known to participant and study staff), single arm study of abiraterone acetate to investigate its efficacy and safety in participants with metastatic castration-resistant prostate cancer (mCRPC) who failed the first-line combined androgen blockade (CAB) therapy. The study consists of Screening Phase (28 days prior to Cycle 1 Day 1), Treatment Phase (up to 2 years), Post Treatment Phase (30 days after the last dose of study drug). Participants will receive 1000 milligram (mg) (four 250 mg tablets) of abiraterone acetate orally once daily. In addition, 5 mg of oral prednisolone will be concomitantly administered twice a day (10 mg per day). A 28-daily dosing cycle will be continued until disease progression or unacceptable toxicity is observed. The total duration of study will be 2 years. Participants will be primarily evaluated for PSA response. Participants' safety will be monitored throughout the study.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Castration-Resistant Prostate Cancer

Interventions

Abiraterone AcetateDRUG

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

PrednisoloneDRUG

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

Eligibility

Sex: MALEMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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) Exclusion Criteria: * 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

Locations (14)

Unnamed facility

Asahi, Japan

Unnamed facility

Higashi-Ibaraki, Japan

Unnamed facility

Kanazawa, Japan

Unnamed facility

Kobe, Japan

Outcomes

Primary Outcomes

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.

Time frame: up to 2 years

Secondary Outcomes

Duration of PSA Response

Duration of PSA response was defined as the duration between the date of confirmed PSA response and subsequent PSA progression date.

Time frame: Up to 2 years

Time to PSA Response

Time to PSA response is the time from start of treatment to PSA progression.

Time frame: Up to 2 years

Percentage of Participants Achieving PSA Response by 24 weeks of Therapy

A PSA response is defined as the first occurrence of greater than or equal to (\>=) 50 percent (%) decrease from baseline by 24 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.

Time frame: Up to 2 years

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

PSA-based Progression-free Survival is the time from randomization to the occurrence of one of the following: radiographic progression, clinical progression or death.

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

Maximum Serum PSA Decline Evaluation

Maximum PSA Decline will be calculated as Baseline PSA level minus lowest PSA level, observed during the 2 year monthly planned PSA lab test and lowest PSA data will be used for calculating the maximum serum PSA decline.

Data from ClinicalTrials.gov

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