IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen

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

Sponsors

Lead Sponsor: Janssen Biotech, Inc.

Source Janssen Biotech, Inc.
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.

Overall Status Active, not recruiting
Start Date May 4, 2011
Completion Date July 31, 2022
Primary Completion Date December 24, 2013
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) During the Core Study End of core study visit (Approximately at Month 6)
Secondary Outcome
Measure Time Frame
Time to Radiographic Evidence of Disease Progression (TTRP) Maximum up to Month 30.5
Time to Prostate-Specific Antigen (PSA) Progression Maximum up to Month 30.5
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) Levels After 3 Cycles of Treatment End of Cycle 3 (Approximately Month 3)
Enrollment 131
Condition
Intervention

Intervention Type: Drug

Intervention Name: abiraterone acetate in combination with prednisone

Description: 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.

Arm Group Label: 001

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

Gender: Male

Minimum Age: 18 Years

Maximum Age: 99 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Janssen Services, LLC. Clinical Trial Study Director Janssen Biotech, Inc.
Location
Facility:
| Homewood, Alabama, United States
| Huntsville, Alabama, United States
| Tucson, Arizona, United States
| Los Angeles, California, United States
| San Diego, California, United States
| San Francisco, California, United States
| Aurora, Colorado, United States
| Denver, Colorado, United States
| Aventura, Florida, United States
| Orange City, Florida, United States
| Atlanta, Georgia, United States
| Evanston, Illinois, United States
| Galesburg, Illinois, United States
| Glenview, Illinois, United States
| Melrose Park, Illinois, United States
| Fort Wayne, Indiana, United States
| Jeffersonville, Indiana, United States
| New Orleans, Louisiana, United States
| Baltimore, Maryland, United States
| Rockville, Maryland, United States
| Boston, Massachusetts, United States
| Lansing, Michigan, United States
| Omaha, Nebraska, United States
| Lawrenceville, New Jersey, United States
| Albany, New York, United States
| Brooklyn, New York, United States
| Buffalo, New York, United States
| Garden City, New York, United States
| New York, New York, United States
| Poughkeepsie, New York, United States
| Staten Island, New York, United States
| Chapel Hill, North Carolina, United States
| Raleigh, North Carolina, United States
| Cincinnati, Ohio, United States
| Cleveland, Ohio, United States
| Lancaster, Pennsylvania, United States
| Philadelphia, Pennsylvania, United States
| Pittsburgh, Pennsylvania, United States
| Greenville, South Carolina, United States
| Myrtle Beach, South Carolina, United States
| Nashville, Tennessee, United States
| Arlington, Texas, United States
| Houston, Texas, United States
| Seattle, Washington, United States
| Milwaukee, Wisconsin, United States
Location Countries

United States

Verification Date

May 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: 001

Type: Experimental

Description: 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 Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov