A Study of Abiraterone Acetate Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy

NCT01695135 | Completed Phase 3 Results

• 2 other identifiers: CR100010ABI-PRO-3001
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 11

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of abiraterone acetate when co-administered with prednisone in Asian patients with metastatic castration-resistant prostate cancer (mCRPC) who have failed docetaxel-based chemotherapy.

Conditions

Prostate Neoplasms

Keywords

Prostate neoplasms; Prostate cancer; Metastatic castration resistant prostate cancer; Abiraterone acetate; JNJ-212082

Outcome Measures

Primary Outcomes (1)

• DB Phase: Time to Prostate-Specific Antigen Progression (PSA)

  Time to PSA progression was defined as time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the Prostate Specific Antigen Working Group (PSAWG) criteria. PSAWG criteria- Decline from baseline and reach response criteria: greater than or equal to (\>=) 50 percent (%) increase over the nadir and the increase in the absolute-value by at least 5 nanogram per milliliter (ng/mL) (or back to the baseline), which is confirmed by a second value 4 or more weeks later; Decline from baseline but not reach response criteria: \>=25% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later; and No decline from baseline: \>=25% increase over the baseline and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later.

  Up to 1.8 years

Secondary Outcomes (7)

• DB Phase: Overall Survival

  From randomization to the date of death due to any cause (up to approximately 3.8 years)

• DB Phase: Percentage of Participants Who Achieved PSA Response

  Approximately up to 3.8 years

• DB Phase: Objective Response Rate (ORR)

  Approximately up to 3.8 years

• DB Phase: Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire: Total Scores at the End of Treatment

  Baseline, at End of Treatment (15 and 30 days after the last dose [up to 3.8 years])

• DB Phase: Time to Pain Progression

  Approximately up to 3.8 years

Study Arms (2)

Abiraterone acetate plus prednisone

EXPERIMENTAL

Drug: Abiraterone acetate; Drug: Prednisone

Placebo plus prednisone

EXPERIMENTAL

Drug: Placebo; Drug: Prednisone

Interventions

Abiraterone acetate DRUG

Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily

Abiraterone acetate plus prednisone

Placebo DRUG

Placebo (4 tablets) taken orally once daily

Placebo plus prednisone

Prednisone DRUG

Prednisone 5 mg tablet taken orally twice daily

Abiraterone acetate plus prednisone; Placebo plus prednisone

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma of the prostate except neuroendocrine carcinoma including small cell carcinoma
• Disease progressed on or after prior docetaxel-containing chemotherapy
• Prior 1 or 2 cytotoxic chemotherapy regimens for metastatic castration-resistant prostate cancer, at least 1 of which contains docetaxel
• Documented prostate cancer progression as documented by prostate specific antigen progression according to Prostate Specific Antigen Working Group criteria or radiographic progression in soft tissue or bone
• Surgically or medically castrated, with serum testosterone level \<50 ng/dL (1.7 nmol/L)
• Eastern Cooperative Oncology Group performance status score of \<=2
• Protocol-defined laboratory values
• Agrees to protocol-defined use of effective contraception

You may not qualify if:

• Active infection or other medical condition that would make prednisone (corticosteroid) use contraindicated
• Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone twice daily
• Pathological finding consistent with neuroendocrine carcinoma of prostate including small cell carcinoma
• Uncontrolled hypertension (systolic BP \>=160 mmHg or diastolic BP \>=95 mmHg; patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy)
• Active or symptomatic viral hepatitis or chronic liver disease, have a known infection with human immunodeficiency virus and/or hepatitis B virus or hepatitis C virus
• History of pituitary or adrenal dysfunction.
• Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association Class III or IV heart disease or cardiac ejection fraction measurement of \<50% at baseline
• Atrial fibrillation, or other cardiac arrhythmia requiring therapy
• Other malignancy within past 3 years (except basal or nonmetastatic squamous cell carcinoma of the skin)
• Known brain metastasis
• Prior therapy with abiraterone acetate or other CYP17 inhibitor(s), or investigational agent(s) targeting the androgen receptor for metastatic prostate cancer
• Prior therapy with ketoconazole for prostate cancer
• Surgery or local prostatic intervention within 30 days of the first dose
• Radiotherapy, chemotherapy, or immunotherapy within 30 days, or single fraction of palliative radiotherapy within 14 days of administration of Cycle 1 Day 1
• Any acute toxicities due to prior chemotherapy and/or radiotherapy that have not resolved to a National Cancer Institute-Common Terminology Criteria for Adverse Events grade of \<=1 (chemotherapy induced alopecia and grade 2 peripheral neuropathy is allowed)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (11)

Unknown Facility

Beijing, China

Location

Unknown Facility

Changsha, China

Location

Unknown Facility

Chongqing, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Hangzhou, China

Location

Unknown Facility

Nanjing, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Suzhou, China

Location

Unknown Facility

Tianjin, China

Location

Unknown Facility

Wenzhou, China

Location

Unknown Facility

Wuhan, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Senior Director
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: September 27, 2012
• Study Start: August 9, 2012
• Primary Completion: June 20, 2014
• Study Completion: May 8, 2018
• Last Updated: July 18, 2019
• Results First Posted: July 18, 2019

Record last verified: 2019-05

Locations

CN (11)