Prostate Cancer Clinical Trial

IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen


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.

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Full 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.

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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

Study is for people with:

Prostate Cancer


Phase 2

Estimated Enrollment:


Study ID:


Recruitment Status:

Active, not recruiting


Janssen Biotech, Inc.

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There is 1 Location for this study

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Homewood Alabama, , United States

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Milwaukee Wisconsin, , United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer


Phase 2

Estimated Enrollment:


Study ID:


Recruitment Status:

Active, not recruiting


Janssen Biotech, Inc.

How clear is this clinincal trial information?


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