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A Phase 2 Open-Label, Randomized, Multi-center Study of Neoadjuvant Abiraterone Acetate (CB7630) Plus Leuprolide Acetate and Prednisone Versus Leuprolide Acetate Alone in Men With Localized High Risk Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

A Phase 2 Open-Label, Randomized, Multi-center Study of Neoadjuvant Abiraterone Acetate (CB7630) Plus Leuprolide Acetate and Prednisone Versus Leuprolide Acetate Alone in Men With Localized High Risk Prostate Cancer

This is an open-label (all people know the identity of the intervention), randomized (the
study drug is assigned by chance), and multi-center (conducted in more than one center)
study of abiraterone in male participants with prostate cancer. The duration of study will
be approximately 24-32 weeks per participant. The study consists of 4 parts: Screening (that
is, 30 days before study commences on Day 1); Treatment (abiraterone acetate 1000 milligram
per day or leuprolide acetate as 22.5 milligram intramuscular injection [injection of a
substance into a muscle] or prednisone 5 mg once daily); Prostatectomy (Week 24); and
Follow-up ( 4-8 weeks after prostatectomy). Participants will receive either abiraterone,
leuprolide and prednisone for 24 weeks (that is, Group 1) or leuprolide once every 12 weeks
up to Week 24 then abiraterone and prednisone from Week 13 to 24 (that is, Group 2). All the
eligible participants will be randomly assigned to 1 of the 2 treatment groups. Efficacy
will be evaluated primarily through the concentrations of testosterone and
dihydrotestosterone from prostate tissues at Week 12. Participants' safety will be monitored
throughout the study.

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the prostate

- At least three core biopsies positive for prostate cancer (a minimum of 6 core
biopsies must be obtained at baseline). A prostate biopsy within 6 months from
Screening is allowed for entry requirements

- At least one of the following features: prostate specific antigen (PSA) greater than
(>) 10 nanogram per milliliter (ng/ml); PSA velocity >2 ng/ml per /year (defined as a
rise in PSA of >2 ng/ml in the preceding 12 month period); Gleason score greater than
or equal to (>=) 7 (4+3); Gleason score 6 if either PSA >=10 ng/ml or PSA velocity
>=2 ng/ml/year

- Serum testosterone >200 nanogram/deciliter

- Participant and urologist must agree that participant is suitable for prostatectomy

Exclusion Criteria:

- Serious or uncontrolled co-existent, non-malignant disease, including active and
uncontrolled infection

- Abnormal liver function consisting of any of the following: serum bilirubin >= 1.5 *
upper limit of normal (ULN); aspartate aminotransferase or alanine aminotransferase
>=2.5 * ULN

- Uncontrolled hypertension within the Screening period (systolic blood pressure
>= 160 millimeter of mercury [mmHg] or diastolic BP >= 95 mmHg)

- Requirement for corticosteroids greater than the equivalent of 5 milligram of
prednisone daily

- Participants with active or symptomatic viral hepatitis or chronic liver disease or
clinically significant heart disease or as evidenced by myocardial infarction,
or arterial thrombotic events in the past 6 months, severe or unstable
angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac
ejection fraction measurement of < 50 percent at Baseline or history of
gastrointestinal disorders (medical disorders or extensive surgery) which may
interfere with the absorption of the study drug or history of pituitary or adrenal

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Testosterone Concentration in Prostate Tissue

Outcome Description:

Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Abiraterone acetate affects sources of testosterone in the body (ie, adrendal gland and prostate tumor). Testosterone concentration was measured in prostate tissues after exposure to study treatments at Week 12.

Outcome Time Frame:

Week 12

Safety Issue:


Principal Investigator

Janssen Research & Development, LLC Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Research & Development, LLC


United States: Food and Drug Administration

Study ID:




Start Date:

November 2009

Completion Date:

March 2012

Related Keywords:

  • Prostate Cancer
  • Prostate cancer
  • Abiraterone acetate
  • Leuprolide acetate
  • Prednisone
  • CB7630
  • Testosterone
  • Prostatic Neoplasms



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