Clinical trial NCT01591122: Study of Abiraterone Acetate Plus Prednisone in Patients With Chemo-naive Metastatic Castration-Resistant Prostate Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Prostate cancer
Metastatic Castration Resistant Prostate Cancer
Abiraterone acetate
Prednisone
Zytiga
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2012-05-03
Enrollment: 313
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to prostate specific antigen (PSA) progression (TTPP)
timeFrame: 14 months
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
measure: Time to initiation of cytotoxic chemotherapy
timeFrame: 5 years
measure: Prostate specific antigen (PSA) response rate
timeFrame: 14 months
measure: Objective response rate
timeFrame: 14 months
measure: Quality of life (QoL) total score and each subscale score
timeFrame: 14 months
measure: Time to pain progression
timeFrame: 14 months
measure: Time to Eastern Cooperative Oncology Group (ECOG) performance status score determination
timeFrame: 14 months
measure: Collection of safety data including adverse events
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
city: Chengdu
country: China
city: Chongqing
country: China
city: Guangzhou
country: China
city: Hangzhou
country: China
city: Jinan
country: China
city: Nanjing
country: China
city: Shanghai
country: China
city: Tianjin
country: China
city: Wuhan
country: China
city: Kuala Lumpur N/a
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Arkhangelsk
country: Russian Federation
city: Ekaterinburg
country: Russian Federation
city: Moscow N/a
country: Russian Federation
city: Moscow
country: Russian Federation
city: Pyatigorsk
country: Russian Federation
city: Rostov-on-Don
country: Russian Federation
city: Sochi
country: Russian Federation
city: St.-Petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Ufa
country: Russian Federation
city: Yoshkar-Ola
country: Russian Federation
city: Bangkok
country: Thailand
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: