Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Time to prostate specific antigen (PSA) progression (TTPP)

Outcome Description:

Measured from the time interval from the date of randomization to the date of the PSA progression based on prostate cancer clinical trials working group 2 (PCWG2) criteria

Outcome Time Frame:

14 months

Safety Issue:

No

Principal Investigator

Janssen Research & Development, LLC Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Research & Development, LLC

Authority:

China: Food and Drug Administration

Study ID:

CR100011

NCT ID:

NCT01591122

Start Date:

March 2012

Completion Date:

February 2014

Related Keywords:

  • Prostate Cancer
  • Prostate cancer
  • Metastatic Castration Resistant Prostate Cancer
  • Abiraterone acetate
  • Prednisone
  • Zytiga
  • Prostatic Neoplasms

Name

Location