Study of Abiraterone Acetate Plus Prednisone in Patients With Chemo-naive Metastatic Castration-Resistant Prostate Cancer

A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

Sponsors

Lead Sponsor: Janssen Research & Development, LLC

Source Janssen Research & Development, LLC
Brief Summary

The purpose of this study is to demonstrate the safety and effectiveness of abiraterone acetate when co-administered with prednisone in patients with chemo-naive metastatic castration resistant prostate Cancer (mCRPC).

Detailed Description

This is a multinational, multicenter, randomized (the study drug is assigned by chance), double-blind (neither physician nor patient knows the treatment that the patient receives), placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) study. All patients will be randomly assigned in a 1:1 ratio between the abiraterone acetate group (abiraterone acetate and prednisone) and the placebo group (placebo and prednisone). The study will consist of a screening phase (within 28 days prior randomization on Cycle 1, Day 1), a treatment phase (28-day cycles until disease progression), and a follow-up phase (all patients will be contacted for every 3 months up to Month 60, focusing primarily on survival status). Patients will receive either abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily or placebo and prednisone 5 mg twice daily.

Overall Status Completed
Start Date March 27, 2012
Completion Date January 31, 2019
Primary Completion Date December 31, 2016
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Time to prostate specific antigen (PSA) progression (TTPP) 14 months
Secondary Outcome
Measure Time Frame
Overall survival 5 years
Time to initiation of cytotoxic chemotherapy 5 years
Prostate specific antigen (PSA) response rate 14 months
Objective response rate 14 months
Quality of life (QoL) total score and each subscale score 14 months
Time to pain progression 14 months
Time to Eastern Cooperative Oncology Group (ECOG) performance status score determination 14 months
Collection of safety data including adverse events 5 years
Enrollment 313
Condition
Intervention

Intervention Type: Drug

Intervention Name: Placebo and prednisone

Description: Placebo: Form=tablet, route=oral. Four tablets daily on an empty stomach. Prednisone: Type=exact number, unit=mg, number=5, form=tablet, route=oral, twice daily.

Arm Group Label: Placebo and prednisone

Intervention Type: Drug

Intervention Name: Abiraterone acetate and prednisone

Description: Abiraterone acetate: Type=exact number, unit=mg, number=250, form=tablet, route=oral. Four tablets daily on an empty stomach Prednisone: Type=exact number, unit=mg, number=5, form=tablet, route=oral, twice daily

Arm Group Label: Abiraterone acetate and prednisone

Eligibility

Criteria:

Inclusion Criteria:

- Has a confirmed diagnosis of adenocarcinoma of the prostate with evidence of metastatic disease

- Prostate cancer progression documented by PSA progression or radiographic progression

- Asymptomatic or mildly symptomatic from prostate cancer

- Surgically or medically castrated, with testosterone levels of <50 ng/dL

- Previous anti-androgen therapy and progression after withdrawal

- ECOG performance status score of 0 or 1

- If opiate analgesics for cancer-related pain, treatment must not be administered within 4 weeks of Cycle 1 Day 1

- If radiation therapy for treatment of the primary tumor is given, treatment must not be administered within 6 weeks of Cycle 1 Day 1

- If previously treated with ketoconazole for prostate cancer, duration of treatment must not be greater than 7 days

- Life expectancy of at least 6 months

Exclusion Criteria:

- 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 small cell carcinoma of the prostate

- Liver or visceral organ metastasis, brain metastasis, and other malignancy, except non-melanoma skin cancer, with a 30% probability of recurrence within 24 months

- Prior cytotoxic chemotherapy or biologic therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC)

- Radiation or radionuclide therapy for treatment of mCRPC

- Uncontrolled hypertension, patients with a history of hypertension are allowed provided blood pressure is controlled by anti hypertensive treatment

- History of pituitary or adrenal dysfunction

Gender: Male

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Janssen Research & Development, LLC Clinical Trial Study Director Janssen Research & Development, LLC
Location
Facility:
| Beijing, China
| Chengdu, China
| Chongqing, China
| Guangzhou, China
| Hangzhou, China
| Jinan, China
| Nanjing, China
| Shanghai, China
| Tianjin, China
| Wuhan, China
| Kuala Lumpur N/a, Malaysia
| Kuala Lumpur, Malaysia
| Arkhangelsk, Russian Federation
| Ekaterinburg, Russian Federation
| Moscow N/a, Russian Federation
| Moscow, Russian Federation
| Pyatigorsk, Russian Federation
| Rostov-on-Don, Russian Federation
| Sochi, Russian Federation
| St.-Petersburg, Russian Federation
| Stavropol, Russian Federation
| Ufa, Russian Federation
| Yoshkar-Ola, Russian Federation
| Bangkok, Thailand
Location Countries

China

Malaysia

Russian Federation

Thailand

Verification Date

January 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Abiraterone acetate and prednisone

Type: Experimental

Label: Placebo and prednisone

Type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov