Clinical trial NCT01756638: A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone in Participants With Prostate Cancer
Official title: A Phase II Study of JNJ-212082 (Abiraterone Acetate) in Metastatic Castration Resistant Prostate Cancer Patients Who Are Chemotherapy-Naïve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate cancer
Abiraterone acetate
JNJ-212082
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2012-12-27
Enrollment: 48
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 investigate safety and efficacy of abiraterone in participants with metastatic castration-resistant prostate cancer (mCRPC) and who have not received prior chemotherapy (treatment of disease, usually cancer, by chemical agents).

Detailed description: This is a multi-center (conducted in more than one center), open-label (all people know the identity of the intervention), single-arm study to investigate safety and efficacy of abiraterone. The study consists of 3 phases: Screening phase (consists of 14 days before study commences on Day -1); Treatment phase (consists of 28-daily dosing cycles wherein abiraterone 1000 milligram \[mg\] once daily along with 5 mg prednisolone twice daily will be given until disease progression or unacceptable toxicity is observed); and Follow-up phase (up to 5 years or until survival after the first dose of study drug). Abiraterone will be orally administered daily as at least 1 hour before the meal or 2 hours after the meal. Dose reduction will be allowed at the Investigator's discretion but not lower than 500 mg per day. Participants will discontinue study treatment at disease progression unless, in the Investigator's opinion, it is deemed that the participants will continue to derive benefit from abiraterone. Efficacy will be evaluated primarily through decline in prostate-specific antigen (substance in blood that is measured to check for prostate cancer) after 12 weeks of therapy. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* In-patients or out-patients with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
* Have surgically or medically castrated, with testosterone levels of less than 50 nanogram per deciliter
* Have prostate-specific antigen (PSA) level of at least 5 nanogram per milliliter
* Be under PSA progression according to Prostate-Specific Antigen Working Group (PSAWG) eligibility criteria or objective progression by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 criteria for participants with measurable disease after androgen deprivation
* Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1

Exclusion Criteria:

* Has received other hormonal therapy, including any dose of finasteride, dutasteride, any herbal product known to decrease PSA levels or any systemic corticosteroid within 4 weeks prior to Cycle 1 Day 1 or has received ketoconazole for prostate cancer
* Has received radiotherapy, chemotherapy (including estramustine) or immunotherapy (including provenge) within 4 weeks, or single fraction of palliative radiotherapy within 2 weeks prior to Cycle 1 Day 1
* Has had surgery or local prostatic intervention within 4 weeks prior to Cycle 1 Day 1. In addition, any clinically relevant sequel from the surgery must have resolved prior to Cycle 1 Day 1
* Has clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events, severe or unstable angina, or New York Heart Association (NYHA) Class 3 to 4 heart disease or cardiac ejection fraction measurement of less than 50 percent within 6 months prior to Cycle 1 Day 1
* Has uncontrolled hypertension (systolic blood pressure greater than or equal to 160 millimeter of mercury or diastolic blood pressure greater than or equal to 95 millimeter of mercury)

Primary outcomes:
measure: Percentage of participants achieving Prostate-Specific Antigen (PSA) response up to 12 weeks
timeFrame: Baseline up to 12 weeks
Secondary outcomes:
measure: Percentage of participants with Radiographic Objective Response
timeFrame: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 5 years
measure: Duration of Prostate-Specific Antigen (PSA) response
timeFrame: Baseline and Day 1 of each cycle up to 5 years
measure: Percentage of participants achieving Prostate-Specific Antigen (PSA) response
timeFrame: Baseline and Day 1 of each cycle up to 5 years
measure: Clinical benefit
timeFrame: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle up to 5 years
measure: Eastern Cooperative Oncology Group Performance Status (ECOG PS) score
timeFrame: Baseline, Day 1, 8, 15 and 22 of Cycle 1 and 2, and thereafter Day 1 and 15 of all cycles up to 5 years
measure: Decline in Serum Prostate-Specific Antigen (PSA)
timeFrame: Baseline and Day 1 of each cycle up to 5 years
measure: Overall survival
timeFrame: Every 3 months until death or up to 5 years
measure: Prostate-Specific Antigen based Progression-free Survival (PSA-PFS)
timeFrame: Baseline and Day 1 of each cycle until first documented disease progression or up to 5 years
measure: Radiographic Progression-free Survival (RAD-PFS)
timeFrame: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 5 years
measure: Percentage of participants with Circulating Tumor Cell (CTC) conversion
timeFrame: Day 1 of Cycle 2, 3, and 4
Other outcomes:
Locations:
city: Asahi
country: Japan
city: Fukuoka
country: Japan
city: Gifu
country: Japan
city: Kanazawa
country: Japan
city: Kashiwa
country: Japan
city: Kita-Gun
country: Japan
city: Kuki
country: Japan
city: Kurashiki
country: Japan
city: Maebashi
country: Japan
city: Matsuyama
country: Japan
city: Mitaka
country: Japan
city: Niigata
country: Japan
city: Osaka-Sayama
country: Japan
city: Osaka
country: Japan
city: Sagamihara
country: Japan
city: Sakura
country: Japan
city: Sapporo
country: Japan
city: Yokohama
country: Japan
city: Yokosuka
country: Japan
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Matsubara N, Uemura H, Satoh T, Suzuki H, Nishiyama T, Uemura H, Hashine K, Imanaka K, Ozono S, Akaza H. A phase 2 trial of abiraterone acetate in Japanese men with metastatic castration-resistant prostate cancer and without prior chemotherapy (JPN-201 study). Jpn J Clin Oncol. 2014 Dec;44(12):1216-26. doi: 10.1093/jjco/hyu149. Epub 2014 Oct 15.