A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone Acetate in Male Participants With Prostate Cancer
Information source: Janssen Research & Development, LLC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: Abiraterone (Drug); Leuprolide (Drug); Prednisone (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Janssen Research & Development, LLC Official(s) and/or principal investigator(s): Janssen Research & Development, LLC Clinical Trial, Study Director, Affiliation: Janssen Research & Development, LLC
Summary
The purpose of this study is to evaluate safety and efficacy of abiraterone acetate plus
leuprolide acetate and prednisone, versus leuprolide acetate alone in male participants with
prostate cancer (a disease in which cells in the prostate gland become abnormal and start to
grow uncontrollably, forming tumors) who are suitable candidates for prostatectomy (surgery
to remove all or part of the prostate gland).
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Testosterone Concentration in Prostate TissueDihydrotestosterone (DHT) Concentration in Prostate Tissue
Secondary outcome: Testosterone and Dihydrotestosterone (DHT) Concentration in Prostate TissueAndrostenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue Serum Levels of Androgens Percentage of Participants With Prostate-specific Antigen (PSA) Response Percentage of Participants With Pathologic Complete Response (CR) Number of Participants With Tumor Expression of Androgen Receptor (AR) Regulated Genes at Week 24 Correlation Between Molecular and Protein Expression With Intracellular Androgen Levels and Pathologic Response to Study Treatment
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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
dysfunction
Locations and Contacts
Boston, Massachusetts, United States
Houston, Texas, United States
Seattle, Washington, United States
Wenatchee, Washington, United States
Additional Information
Starting date: November 2009
Last updated: March 6, 2013
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