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IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01314118
Recruitment Status : Active, not recruiting
First Posted : March 14, 2011
Results First Posted : January 7, 2015
Last Update Posted : December 3, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Biotech, Inc.

Tracking Information
First Submitted Date  ICMJE March 4, 2011
First Posted Date  ICMJE March 14, 2011
Results First Submitted Date  ICMJE December 24, 2014
Results First Posted Date  ICMJE January 7, 2015
Last Update Posted Date December 3, 2021
Actual Study Start Date  ICMJE May 4, 2011
Actual Primary Completion Date December 24, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 24, 2014)
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) During the Core Study [ Time Frame: End of core study visit (Approximately at Month 6) ]
Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed.
Original Primary Outcome Measures  ICMJE
 (submitted: March 10, 2011)
The proportion of patients with = 50% reduction in PSA after 6 cycles of treatment [ Time Frame: Approximately 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 24, 2014)
  • Time to Radiographic Evidence of Disease Progression (TTRP) [ Time Frame: Maximum up to Month 30.5 ]
    Time to radiographic evidence of disease progression is defined as the time interval from the date of enrollment (Day 1) to the date of disease progression. A participant was considered as progressed by bone scan if: 1) The appearance of greater than or equal to (>=) 2 new lesions, and, following the first assessment, a confirmatory scan performed 6 or more weeks later that shows a minimum of 2 or more additional new lesions, 2) If >=2 new lesions are seen on scans following the first assessment, the confirmation is still required after 6 weeks; however, 2 addition lesions are not required to confirm progression, and 3) The date of progression is the date of the first scan that shows the changes.
  • Time to Prostate-Specific Antigen (PSA) Progression [ Time Frame: Maximum up to Month 30.5 ]
    Time to PSA progression is defined as the time interval from the date of enrollment (Day 1) to the date of first evidence of PSA progression. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase and an absolute increase of 2 nanogram (ng)/milliliter (mL) or more, which is confirmed by a second value obtained in 3 or more weeks.
  • Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) Levels After 3 Cycles of Treatment [ Time Frame: End of Cycle 3 (Approximately Month 3) ]
    Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed. Decrease in PSA levels represented improvement.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2011)
  • The proportion of subjects with a = 50% reduction in PSA levels after 3 cycles of treatment and absolute PSA reduction [ Time Frame: Approximately 3 months ]
  • The proportion of subjects with evidence of radiographic disease progression over time [ Time Frame: Approximately or an average of 24 months. Disease progression is measured throughout the study duration ]
  • Testosterone over time [ Time Frame: Approximately 3 and 6 months ]
  • Time to radiographic evidence of disease progression [ Time Frame: Approximately or an average of 24 months. Disease progression is measured throughout the study duration ]
  • Time to PSA (Prostate Specific Antigen) progression [ Time Frame: Approximately or an average of 24 months. PSA levels are measured throughout the study duration ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostate Cancer
  • Prostatic Neoplasm
Intervention  ICMJE Drug: abiraterone acetate in combination with prednisone
Abiraterone acetate will be taken as 4 x 250 mg tablets by mouth (PO) once daily. Prednisone will be taken as 2 x 2.5 mg tablets PO once daily.
Study Arms  ICMJE Experimental: 001
abiraterone acetate in combination with prednisone Abiraterone acetate will be taken as 4 x 250 mg tablets by mouth (PO) once daily. Prednisone will be taken as 2 x 2.5 mg tablets PO once daily.
Intervention: Drug: abiraterone acetate in combination with prednisone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 7, 2017)
131
Original Estimated Enrollment  ICMJE
 (submitted: March 10, 2011)
125
Estimated Study Completion Date  ICMJE July 31, 2024
Actual Primary Completion Date December 24, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01314118
Other Study ID Numbers  ICMJE CR017932
Protocol 212082PCR2005 ( Other Identifier: Janssen Biotech Inc. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Biotech, Inc.
Study Sponsor  ICMJE Janssen Biotech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Services, LLC. Clinical Trial Janssen Biotech, Inc.
PRS Account Janssen Biotech, Inc.
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP