Clinical trial NCT02405858: A Study of Abiraterone Acetate in Metastatic Castration-Resistant Prostate Cancer Participants Who Responded Poorly to the First-line Combined Androgen Blockade Therapy
Official title: A Phase 4 Study of Zytiga in Poor-risk mCRPC (Metastatic Castration-Resistant Prostate Cancer) Patients Who Was Failed the First-line CAB (Combined Androgen Blockade) Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metastatic Castration-Resistant Prostate Cancer
Keywords: Metastatic Castration-Resistant Prostate Cancer
Abiraterone Acetate
ZYTIGA
Prednisolone
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2015-04-01
Enrollment: 51
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Achieving Prostate-specific Antigen (PSA) Response (PSA Response Rate) by 12 Weeks of Therapy
timeFrame: up to 2 years
Secondary outcomes:
measure: Duration of PSA Response
timeFrame: Up to 2 years
measure: Time to PSA Response
timeFrame: Up to 2 years
measure: Percentage of Participants Achieving PSA Response by 24 weeks of Therapy
timeFrame: Up to 2 years
measure: PSA-based Progression-free Survival (PSA-PFS)
timeFrame: Time from randomization up to radiographic progression, clinical progression or death, whichever occurs first (maximum up to 2 years)
measure: Maximum Serum PSA Decline Evaluation
timeFrame: Baseline and Day 1 of each cycle up to 2 years
measure: Percentage of Participants With Radiographic Objective Response Rate (RAD-ORR) in Participants with Measurable Lesions at Baseline
timeFrame: Baseline, Day 1 of Cycle 1, 2,3 and 4 until first documented disease progression or up to 2 years
measure: Radiographic Progression-free Survival (RAD-PFS)
timeFrame: Time from enrollment up to radiographic progression or death, whichever occurs first (up to 2 years)
measure: Time to Next Treatment
timeFrame: up to 2 years
measure: Overall Survival
timeFrame: Time from enrollment to date of death due to any cause (up to 2 years)
measure: Brief Pain Inventory - Short Form
timeFrame: Baseline, Day 1 of Cycle 1, 2,3 and 4 up to 2 years
measure: Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Asahi
country: Japan
city: Higashi-Ibaraki
country: Japan
city: Kanazawa
country: Japan
city: Kobe
country: Japan
city: Koshigaya
country: Japan
city: Kumamoto
country: Japan
city: Narashino
country: Japan
city: Okayama
country: Japan
city: Sagamihara
country: Japan
city: Sakura
country: Japan
city: Shinjuku-Ku
country: Japan
city: Sunto
country: Japan
city: Yokohama
country: Japan
city: Yokosuka
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: