Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer

Active, not recruiting
Trial end date:
Target enrollment:
Participant gender:
This phase II trial studies how well finite androgen ablation with or without abiraterone acetate and prednisone work in treating patients with prostate cancer that has come back. Androgen can cause the growth of prostate cancer cells. Hormone therapy, such as finite androgen ablation, using leuprolide acetate, goserelin acetate, degarelix, bicalutamide, flutamide, and nilutamide may fight prostate cancer by lowering the amount of androgen the body makes. Abiraterone acetate may help to decrease the production of testosterone, and prednisone may help lower or prevent some side effects. It is not yet known whether giving acetate, goserelin acetate, degarelix, bicalutamide, flutamide, and nilutamide with or without abiraterone acetate and prednisone may work better in treating patients with prostate cancer.
Phase 2
Accepts Healthy Volunteers?
Lead Sponsor:
M.D. Anderson Cancer Center
Janssen Services, LLC
Abiraterone Acetate
Inclusion Criteria:

- Have signed an informed consent document indicating that the subjects understand the
purpose of and procedures required for the study and are willing to participate in the

- Written Authorization for Use and Release of Health and Research Study Information has
been obtained

- Be willing/able to adhere to the prohibitions and restrictions specified in this

- Life expectancy >= 12 months

- ECOG performance status (PS) =< 2

- Histologically documented diagnosis of adenocarcinoma of the prostate (PCa) with no
histologic variants

- Prostate cancer recurrence after definitive local therapy (radical prostatectomy
and/or radiation therapy) as evidenced by rising serum PSA, without evidence of
metastases by bone scan or computed tomography (CT) scan

- After radiation: A rising PSA taken to indicate recurrent prostate cancer in
patients with previous definitive external beam radiotherapy will be defined as
PSA of 1.0

- After Radical Prostatectomy: A rising PSA taken to indicate recurrent prostate
cancer in patients with previous radical prostatectomy will be defined by the
criteria of the American Urological Association as any PSA measurement of 0.2,
with a subsequent measurement > 0.2 ng/mL

- Patients who have received androgen ablative therapy for less than 8 weeks immediately
prior to initiation of study drug are eligible provided they had only PSA evidence of
progression (as defined above) with no visible metastases by CT-scan and bone scan
(within 6 weeks) prior to starting androgen ablation

- White blood cell (WBC) >= 3.5 x 10^9/L

- Absolute neutrophil count (ANC) >= 1.5 x 10^9/L

- Platelets >= 100 x 10^9/L

- Hemoglobin (Hb) >= 9.0 g/dL

- Total bilirubin =< 1.5 x upper limit of normal (ULN)

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x the upper
limit of normal

- Serum potassium of >= 3.5 mEq/L

- Serum albumin of >= 3.0 g/dL

- Serum creatinine =< 1.5 x ULN

- Patients must have recovered from prior treatment regimens, e.g. surgery, radiation

- A patient who is sexually active and their partner must agree and use two reliable
barrier forms of contraception (for example, condoms and diaphragm), from first day of
study drug administration until for 1 week after last dose of abiraterone acetate,
unless partner is post-menopausal

- Able to swallow the study drug whole as a tablet

- Willing to take abiraterone acetate on an empty stomach; no food should be consumed at
least two hours before and for at least one hour after the dose of abiraterone acetate
is taken

Exclusion Criteria:

- Patients who have received prior hormonal therapy are excluded from the trial, except
for: patients who have received up to 6 months of hormonal therapy as neoadjuvant
therapy before radical prostatectomy or while on radiation therapy, as long as more
than 1 year has elapsed between discontinuation of the neoadjuvant hormonal therapy
and initiation of hormonal treatment for relapsing disease

- Any known metastases

- Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (>= 450 msec)

- Clinically significant heart disease as evidenced by myocardial infarction, or
arterial thrombotic events in the past 6 months, severe or unstable angina, or New
York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction
measurement of < 50% at baseline

- Significant co-morbidity that could affect the safety or evaluability of participants
as assessed by the treating physician and or principal investigator

- Prior therapy with strontium-89, samarium, rhenium-186 etidronate, chemotherapy or
androgen biosynthesis inhibitors for prostate cancer is not allowed. Previous
immunologic, homeopathic, natural, or alternative medicine therapies are acceptable
provided treatment ended greater than 28 days prior to initiation of study drug

- Patients who, in the opinion of the investigator, are unable to comply with the
requirements of the study protocol are not eligible

- Active infection or other medical condition that would make prednisone/prednisolone
(corticosteroid) use contraindicated

- Active or symptomatic viral hepatitis

- History of pituitary or adrenal dysfunction

- Administration of an investigational therapeutic drug within 30 days of cycle 1 day 1

- Have known allergies, hypersensitivity, or intolerance to abiraterone acetate or
prednisone or their excipients

- Have a history of gastrointestinal disorders (medical disorders or extensive surgery)
that may interfere with the absorption of the study agents

- Have a pre-existing condition that warrants long-term corticosteroid use in excess of
study dose