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Phase II Trial of Radiation With Androgen Deprivation (AbiRAD): Abiraterone Acetate, Prednisone and LHRH Agonist Prior to and Concurrent With Radiation Therapy

Phase 2
18 Years
Open (Enrolling)
Adenocarcinoma of the Prostate, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer, Stage IV Prostate Cancer

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Trial Information

Phase II Trial of Radiation With Androgen Deprivation (AbiRAD): Abiraterone Acetate, Prednisone and LHRH Agonist Prior to and Concurrent With Radiation Therapy


I. To evaluate the safety of abiraterone (abiraterone acetate) and prednisone with
luteinizing hormone-releasing hormone (LHRH) agonist given as neoadjuvant and concurrent
therapy with external beam radiation in patients with localized prostate cancer.

II. To determine whether pharmacologic suppression of the prostatic androgen axis by
inhibition of androgen production with abiraterone can decrease tissue androgen levels to
below those observed with gonadotropin-releasing hormone (GnRH) agonist suppression of
testicular androgens.


I. To determine whether treatment with abiraterone acetate with LHRH agonist will be more
effective than LHRH agonist with bicalutamide in inducing inhibition of androgen-regulated
gene expression and increased apoptotic cell death as assessed by immunohistochemistry,
complementary deoxyribonucleic acid (cDNA) microarray analysis and reverse
transcription-polymerase chain reaction (RT-PCR).

II. To evaluate time to prostate-specific antigen (PSA) progression in patients treated with
LHRH agonist with abiraterone acetate.


Patients receive abiraterone acetate orally (PO) and prednisone PO once daily (QD) for 24
weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients
undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in
the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 5 years.

Inclusion Criteria:

- Willing and able to provide written informed consent

- Patients must allow biopsy prior to neoadjuvant therapy and at the time of fiducial

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

- Histologically proven adenocarcinoma of the prostate

- Patients must be candidates for short or long term androgen deprivation in
combination with external beam radiotherapy (RT) based on the following criteria:

- Intermediate Risk Disease: T2b/c, or Gleason 7, or PSA 10-20

- High Risk Disease: Gleason 8-10, or PSA > 20, or T3/4

- Patients may not have received any prior pharmacologic therapy or RT for prostate

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2

- Karnofsky >= 60%

- Eligibility of patients receiving any medications or substances known to affect or
with the potential to affect the androgen axis will be determined following review of
their case by the Principal Investigator

- White blood cell count: >= 3,000/mm^3

- Absolute granulocyte count: >= 1,000/mm^3

- Platelets: >= 100,000/mm^3

- Hemoglobin >= 10g/dL

- Potassium >= 3.5 mmol/L

- Serum creatinine: =< 1.5 x upper limit of normal (ULN)

- Aspartate aminotransferase (AST) < 2.5 x ULN

- Alanine transaminase (ALT) < 2.5 x ULN

- Total bilirubin: =< 1.5 x ULN (except for patients with documented Gilbert's disease)

Exclusion Criteria:

- Patients may not be receiving any investigational agents

- Concurrent enrollment in another clinical investigational drug or device study is

- The concurrent administration of other anticancer therapy, including cytotoxic or
hormonal agents (except LHRH agonists), or immunotherapy, is prohibited during
neoadjuvant concurrent and adjuvant therapy

- Patients who are currently receiving active therapy for other neoplastic disorders
will not be eligible

- Patients with histologic evidence of small cell carcinoma of the prostate will not be

- Patients with hypogonadism or severe androgen deficiency as defined by serum
testosterone less than 100 ng/dL will not be eligible

- History of pituitary or adrenal dysfunction

- Patients who are receiving any androgens, estrogens or progestational agents, or who
received any of these agents within the 6 months prior to evaluation will not be

- Patients who are taking drugs which affect androgen metabolism (e.g. spironolactone,
ketoconazole, finasteride, dutasteride) will not be eligible

- Concomitant therapy with any of the following listed is prohibited: 5 alpha-reductase
inhibitor (finasteride, dutasteride); ketoconazole, diethylstilbestrol, PC-SPES, and
other preparations such as saw palmetto thought to have endocrine effects on prostate
cancer; radiopharmaceuticals such as strontium (89Sr) or samarium (153Sm); Aldactone,
Spironol (spironolactone); estrogens, testosterone, progesterones, herbal medications

- Patients who received any of these agents within the 6 months prior to evaluation
will be reviewed for eligibility by the Principal Investigator on a case by case

- Use of other investigational drug therapy for any reason is prohibited

- Patients with inflammatory bowel disease or other autoimmune conditions which might
affect the radiated colon or rectum

- Patients with uncontrolled intercurrent illness including, but not limited to,
ongoing or active infection, unstable angina pectoris, cardiac arrhythmia which is
symptomatic or requires active therapy, recent deep venous thrombosis, pulmonary
emboli, cerebrovascular accident or ischemia will not be eligible

- Patients who have chronic active hepatitis or acute hepatitis will not be eligible

- Patients with dementia/psychiatric illness/social situations that would limit
compliance with study requirements or would prohibit the understanding and/or giving
of informed consent will not be eligible

- Patients with medical conditions, which, in the opinion of the investigators, would
jeopardize either the patient or the integrity of the data obtained will not be

- Uncontrolled hypertension within the screening period (systolic blood pressure [BP]
>= 160 mmHg or diastolic BP >= 95 mmHg)

- Patients with a history of hypertension are allowed provided blood pressure is
controlled by anti-hypertensive therapy

- History of congestive heart failure of any severity

- Other active malignancy, except non-melanoma skin cancer and superficial bladder

- History of gastrointestinal disorders (medical disorders or extensive surgery) which
may interfere with the absorption of the study drug

- Patients with diabetes not controlled with diet alone (i.e. requiring insulin or oral

- Patients unwilling to use contraceptives while on study

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of acute and chronic grade 3 or greater toxicity as evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0

Outcome Description:

The distribution of time to late adverse events (observed severities of adverse events over time) will be estimated using the Kaplan-Meier method.

Outcome Time Frame:

Up to 24 months after initiation of radiation therapy

Safety Issue:


Principal Investigator

Robert Montgomery

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium


United States: Food and Drug Administration

Study ID:




Start Date:

March 2010

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Prostate
  • Stage IIA Prostate Cancer
  • Stage IIB Prostate Cancer
  • Stage III Prostate Cancer
  • Stage IV Prostate Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms



Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109
MultiCare Regional Cancer Center AuburnAuburn, Washington  98002