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A Multicenter, Open-label, Single-arm, Phase 2 Study of Abiraterone Acetate Plus Prednisone in Subjects With Advanced Prostate Cancer Without Radiographic Evidence of Metastatic Disease


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer, Prostatic Neoplasm

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Trial Information

A Multicenter, Open-label, Single-arm, Phase 2 Study of Abiraterone Acetate Plus Prednisone in Subjects With Advanced Prostate Cancer Without Radiographic Evidence of Metastatic Disease


This is a Phase 2, prospective, multicenter, open-label (both the patient and investigator
will know what treatment is taken), single-arm study of abiraterone acetate plus prednisone
in patients with non-metastatic (has not spread in the body), castration-resistant prostate
cancer (CRPC) who have a rising PSA despite castrate levels of testosterone. This study has
4 phases: Screening Phase (up to 28 Days); Core Study Treatment Phase (Treatment-Cycle 1-6);
Follow-up Phase (Treatment-Cycle 7- until disease progression); and an Extension Phase
(after the end of the official study). Each treatment cycle will last 28 days (about a
month). Your participation in the study will include a screening period of up to 28 days,
which allows the doctor to assess whether or not you qualify for the study. There is a Core
Treatment Phase where study medication is taken for six treatment cycles (about 6 months).
There is a Follow-up Phase where study medication will continue to be taken until your
prostate cancer progresses, or you have unacceptable toxicities or this phase of the study
ends (approximately 18 months). If your prostate cancer progresses before the end of the
follow-up phase, you will not be given further study medication. However, the study doctor
will contact you about every 2 months to record any new therapy for prostate cancer you are
taking until the end of the follow-up phase. If for some reason you stop study medication
before the end of the follow-up phase, the study doctor will contact you about every 2
months to record any new therapy for prostate cancer you are taking until the end of the
follow-up phase or until your prostate cancer progresses, whichever happens first. You will
be required to return to the study site 30 days after receiving your last dose of
abiraterone acetate for safety follow-up. You may be in the study for about 24 months. Four
abiraterone acetate tablets should be taken by mouth [PO] at least 2 hours after eating & no
food should be eaten for at least 1 hour afterward. Two (2.5 mg) prednisone tablets will be
taken PO once daily, preferably with food. Patients may continue abiraterone acetate until
disease progression, until unacceptable toxicities develop, until abiraterone acetate
becomes commercially available for the indication being studied, or until the sponsor
determines it is necessary to stop the study.


Major

Inclusion Criteria:



- Be a male >= 18 years of age

- Have adenocarcinoma of the prostate

- Currently receiving continuous treatment with Gonadotropin-releasing hormone (GnRH)
monotherapy for at least 6 months before or have undergone surgical removal of the
testicles

- Serum testosterone of < 50 ng/dL(< 2.0 nM)

- Have rising PSA defined as a PSA of ≥ 10 ng/mL obtained at screening or PSADT of ≤ 10
months with the first of the 3 consecutive PSA values used to calculate PSADT ≥ 2.0
ng/mL

- Have an Eastern Cooperative Oncology Group (ECOG) performance status less than or
equal to 2

- Be capable of swallowing study agents whole as a tablet

- Be willing/able to adhere to the prohibitions and restrictions specified in this
protocol

Major Exclusion Criteria:

- Have prior or current evidence of local disease progression or metastatic disease as
defined by modified response evaluation criteria in solid tumors (RECIST) criteria

- Have received chemotherapy for treatment of castrate-resistant prostate cancer;
however, if a patient received chemotherapy in an adjuvant setting, prior to having
CRPC, for castrate-sensitive prostate cancer, the patient is still eligible

- Are currently receiving any antiandrogen therapy (eg, bicalutamide, flutamide, or
nilutamide).

- If previously treated with antiandrogen therapy, there must be documentation of at
least 2 consecutive rising PSA values at least 2 weeks apart obtained prior to
screening

- If previously treated with flutamide, at least 1 of the PSA values must be obtained 4
weeks or more after flutamide discontinuation.

- If previously treated with bicalutamide or nilutamide, at least 1 of the PSA values
must be obtained 6 weeks or more after antiandrogen discontinuation

- Have previously received agents having any CYP17 inhibitory activity for the
treatment of prostate cancer, such as ketoconazole

- Have previously received aminoglutethimide

- Have an active infection or other medical condition that would contraindicate
prednisone use

- Have uncontrolled hypertension

- Have active hepatitis or chronic liver disease

- Have clinically significant heart disease

- Have poorly controlled diabetes

- Have received an investigational therapeutic within 30 days of screening

- Have partners of childbearing potential and are not willing to use a method of birth
control with adequate barrier protection as determined to be acceptable by the
principal investigator and sponsor during the study and for 1 week after last dose of
abiraterone acetate.

- Individuals with a history of a non-prostate malignancy are ineligible for this study
with the following exceptions. Individuals with a history of other malignancies are
eligible if they have been disease-free for at least 3 years and are deemed by the
investigator to be at low risk for recurrence of that malignancy. Individuals with
the following cancers are eligible if diagnosed and treated within the past 3 years:
basal cell or squamous cell carcinoma of the skin

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The proportion of patients with >= 50% reduction in PSA after 6 cycles of treatment or by the End of Core Study Visit

Outcome Time Frame:

Approximately 6 months

Safety Issue:

No

Principal Investigator

Janssen Services, LLC. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Biotech, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

CR017932

NCT ID:

NCT01314118

Start Date:

May 2011

Completion Date:

July 2015

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasm
  • abiraterone acetate
  • prednisone
  • zytiga
  • Neoplasms
  • Prostatic Neoplasms

Name

Location

Hinsdale, Illinois  60521
Albany, Georgia  31701
Birmingham, Alabama  35294
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
Omaha, Nebraska  68114
Hackensack, New Jersey  07601
Metairie, Louisiana  70006
Denver, Colorado  
Baltimore, Maryland  21287
Boston, Massachusetts  
Charlotte, North Carolina  
Milwaukee, Wisconsin  
Indianapolis, Indiana  
Charleston, South Carolina