IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen
Status: Recruiting
Phase:
Diagnosis: Prostate Cancer
NCT ID: NCT01314118
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-161
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.
Conducting Institutions:
Dana-Farber Cancer Institute
Overall PI:
Mary-Ellen Taplin, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Contacts:
Dana-Farber Cancer Institute:
Judith Prisby, 617-632-5068,
jprisby@partners.org
Eligibility Criteria
Inclusion Criteria:
- Be a male >= 18 years of age
- Have adenocarcinoma of the prostate
- Currently receiving and must have had continuous therapy with Gonadotropin-releasing
hormone (GnRH) monotherapy for at least 6 months before screening, with a serum
testosterone of < 50 nanograms/deciliter (< 2.0 nanograms per milliliter) or have
undergone surgical removal of the testicles with a blood testosterone level of < 50
nanograms per deciliter (<2.0 nanograms per millimeter)
- Have rising Prostate Specific Antigen (PSA) after local therapy and treatment with
GnRH monotherapy (defined as a PSA of greater than or equal to 10
nanograms/milliliter obtained at screening or PSADT (prostate-specific antigen
doubling time) of < or equal to 6 months with a baseline PSA of greater than or equal
to 2.0 nanograms/milliliter)
- 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
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
- Have a Prostate Specific Androgen Doubling Time (PSADT) of greater than 15 months
- Subjects may not be currently receiving any antiandrogen therapy (e.g., bicalutamide,
flutamide, or nilutamide) or have received agents having any CYP17 (a key enzyme in
the production of testosterone) inhibitory activity (such as ketoconazole) or
aminoglutethimide. For subjects previously treated with antiandrogen therapy, there
must be documentation of at least 2 consecutive rising PSA values, obtained at least
2 weeks apart
- For subjects previously treated with flutamide, at least 1 of the PSA values must be
obtained 4 weeks or more after flutamide discontinuation
- For subjects previously treated with bicalutamide or nilutamide, at least 1 of the
PSA values must be obtained 6 weeks or more after antiandrogen discontinuation
- Have an active infection or other medical condition that would contraindicate
prednisone use
- Have human immunodeficiency virus (HIV) or any other form of severe immunocompromise
- 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 13 weeks after last
abiraterone acetate administration
- Have had a malignancy excluding prostate cancer and nonmelanoma skin cancer (treated
with no evidence of recurrence).