Clinical trial NCT01314118: IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Prostatic Neoplasm
Keywords: abiraterone acetate
prednisone
zytiga
Lead sponsor: Janssen Biotech, Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-14
Enrollment: 131
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to show that abiraterone acetate plus prednisone added to the current standard of care, gonadotropin-releasing hormone (GnRH) decreases prostate specific antigen (PSA) and prolongs the time until it is evident that the cancer has grown. Additionally, safety information about abiraterone acetate in combination with prednisone will be collected. This will include looking at what side effects occur, how often they occur, and for how long they last.

Detailed description: This is a Phase 2, prospective, multicenter, open-label, single-arm study of abiraterone acetate plus prednisone in men with non-metastatic, castration-resistant prostate cancer (CRPC) who have a rising PSA despite castrate levels of testosterone. The study consists of Screening Phase (up to 4 weeks), Core Study Treatment Phase (comprised of six 28-day cycles), a Pre-metastatic Disease Follow-up Phase, an Optional Drug Holiday Phase; and a 30-day Safety Follow-up Visit. Each treatment cycle will last 28 days. Participating participants will receive study agents (Abiraterone acetate 1000 mg/day plus prednisone 5 mg/day, orally) continually during the study. If the partcipants elects to participate in the Optional Drug Holiday Phase, participants will discontinue abiraterone acetate plus prednisone and ADT. Participants will have the option to return to study medication during the first year of the Optional Drug Holiday Phase if there is evidence of rising PSA but no metastasis based on study imaging. If participants do no elect to participate, they will continue with the core study treatment as per protocol. The study will end when all participated participants have disease progression or end of the 2-year period (if participants participated in the Optional Drug Holiday Phase). Participants will be required to return to the study site 30 days after receiving the last dose of abiraterone acetate for safety follow-up.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) During the Core Study
timeFrame: End of core study visit (Approximately at Month 6)
Secondary outcomes:
measure: Time to Radiographic Evidence of Disease Progression (TTRP)
timeFrame: Maximum up to Month 30.5
measure: Time to Prostate-Specific Antigen (PSA) Progression
timeFrame: Maximum up to Month 30.5
measure: Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) Levels After 3 Cycles of Treatment
timeFrame: End of Cycle 3 (Approximately Month 3)
Other outcomes:
Locations:
city: Homewood
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Aventura
country: United States
state: Florida
city: Orange City
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Evanston
country: United States
state: Illinois
city: Galesburg
country: United States
state: Illinois
city: Glenview
country: United States
state: Illinois
city: Melrose Park
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: Jeffersonville
country: United States
state: Indiana
city: New Orleans
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Rockville
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Lansing
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Lawrenceville
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: Buffalo
country: United States
state: New York
city: Garden City
country: United States
state: New York
city: New York
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Lancaster
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Greenville
country: United States
state: South Carolina
city: Myrtle Beach
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: Janssen Biotech, Inc.
name: Janssen Services, LLC. Clinical Trial
role: STUDY_DIRECTOR
References: