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Abiraterone Acetate Treatment for Prostate Cancer Patients With a PSA of More Than Four Following Initial Androgen Deprivation Therapy Phase II

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

Abiraterone Acetate Treatment for Prostate Cancer Patients With a PSA of More Than Four Following Initial Androgen Deprivation Therapy Phase II



- To assess the rate of achieving a prostate-specific antigen (PSA) of ≤ 0.2 ng/mL with
abiraterone acetate therapy in men with metastatic prostate cancer with a sub-optimal
response to androgen-deprivation therapy (ADT).


- To assess the overall survival and objective progression-free survival of this group of

- To assess PSA partial response.

- To evaluate the qualitative and quantitative toxicity of abiraterone acetate.

OUTLINE: This is a multicenter study.

Patients receive abiraterone acetate orally daily on days 1-28. Courses repeat every 28 days
in the absence of disease progression or unacceptable toxicity.

Patients receive androgen blockade with GNRH agonist (goserelin acetate or leuprolide
acetate) or a GNRH antagonist (degarelix) per the treating physician and this will be given
continuously until evidence of disease progression. Bilateral surgical orchiectomy is also

After completion of study therapy, patients are followed up every 3 months for 1 year and
then every 6 months for up to 3 years.

Inclusion Criteria


- Histologically or cytologically proven diagnosis of adenocarcinoma of the prostate

- Metastatic (M1) disease as evidenced by soft tissue and/or bony metastases at
the time of initiation of androgen-deprivation therapy (ADT)

- Must have at least one of the following:

- Visceral disease (liver, lung, other viscera)

- Bone metastases to sites in either the axial (spine, pelvis, ribs, or
skull) and/or the appendicular (clavicle, humerus, or femur) skeleton

- Distant lymph node disease (e.g., above the aortic bifurcation, etc.)

- No small cell or neuroendocrine prostate cancer

- Patients must be receiving ADT (e.g., gonadotropin-releasing hormone [GNRH]
antagonist, with or without antiandrogen) prior to entering this study

- Degarelix, a FDA-approved GNRH antagonist, is an acceptable form of ADT

- Bilateral surgical orchiectomy is also acceptable

- Suboptimal response to ADT induction as defined by the following criteria:

- Declining PSA (current PSA is less than the PSA prior to starting ADT) that
fails to reach 4 ng/mL or below despite continuous ADT

- PSA of > 4 ng/mL must be observed between 6-12 months after the initiation
of ADT

- Documentation of failure to achieve this PSA of ≤ 4 ng/mL must be within 28
days of registration

- The PSA must be obtained after any applicable antiandrogen washout

- If the PSA is declining or stable (defined as a PSA rise ≤ 0.1 ng/mL from
nadir) and the patient is on an antiandrogen, they must remain on the

- Patients with stable or declining PSA who have had previous antiandrogen
exposure, but are not taking an antiandrogen at the time of registration,
must wait at least 6 weeks from the last antiandrogen dose before
registration and still demonstrate a stable or falling PSA which is > 4
ng/mL by month 12, in order to be eligible

- If the PSA is rising and they are on an antiandrogen, formal antiandrogen
washout must be performed (4 weeks for flutamide and 6 weeks for
bicalutamide and nilutamide with no evidence of a falling PSA after

- No patients with radiographic progression when compared to available imaging
studies performed prior to starting the GNRH agonist/antagonist therapy

- Patients who have measurable disease must have radiographic assessment (at least an
abdominal/pelvic CT scan) within 28 days prior to registration

- Non-measurable disease must be assessed (i.e., bone scan) within 42 days prior to

- No patients with a history of brain metastases or who currently have treated or
untreated brain metastases

- Patients with clinical evidence of brain metastases must have a brain CT scan or
MRI negative for metastatic disease within 56 days prior to registration


- Zubrod performance status 0-2

- ANC ≥ 1,500/μL

- Platelet count ≥ 100,000/μL

- Hemoglobin ≥ 10 g/dL

- Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) OR creatinine clearance
≥ 60 mL/min

- Bilirubin ≤ 1.5 times ULN (unless documented Gilbert disease)

- AST and ALT < 1.5 times ULN

- Potassium ≥ 3.5 mmol/L

- Patient must have a testosterone value of < 50 ng/dL obtained within 28 days prior to

- Patients must have controlled blood pressure defined as systolic blood pressure < 160
mm Hg and diastolic blood pressure < 95 mm Hg

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

- Patients who have partners of child-bearing potential must be willing to use a method
of birth control with adequate barrier protection during the study and for 1 week
after the last study drug administration

- Must be able to take oral medication without crushing, dissolving, or chewing tablets

- Patients must not have a history of gastrointestinal disorders (medical disorders or
extensive surgery) that may interfere with the absorption of abiraterone acetate

- No other prior malignancy is allowed except for any of the following:

- Adequately treated basal cell or squamous cell skin cancer

- Adequately treated stage I or II cancer from which the patient is currently in
complete remission

- Any other cancer from which the patient has been disease-free for 5 years

- No patients with active or symptomatic viral hepatitis or chronic liver disease

- No moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment

- No history of NYHA class III or IV heart failure

- Patients must have LVEF ≥ 50%

- No known allergies, hypersensitivity, or intolerance to abiraterone acetate,
prednisone, or their excipients


- See Disease Characteristics

- Patients with a history of prior neoadjuvant or adjuvant GNRH agonist/antagonist
therapy (related to previous surgery or radiation) are eligible provided they
finished this therapy at least two years prior to registration

- Prior enrollment to SWOG-S0925 (either arm) is not exclusionary

- At least 6 weeks since prior and no concurrent finasteride or dutasteride

- At least 28 days since prior radiotherapy or surgery and recovered

- At least 4 weeks since prior investigational products

- At least 4 weeks since prior flutamide (6 weeks for bicalutamide and nilutamide) with
no evidence of a falling PSA

- No other concurrent oral antiandrogen

- No prior or concurrent cytotoxic chemotherapy or radiopharmaceuticals for prostate

- No prior or concurrent ketoconazole for the treatment of prostate cancer

- Not requiring more than 10 mg a day of prednisone for another medical indication

- Not planning to receive any concurrent cytotoxic chemotherapy, immunotherapy,
surgery, or radiotherapy during protocol treatment

- No concurrent hormonal-acting agents, including diethylstilbestrol/DES, aldosterone,
PC-SPES, or spironolactone

- No concurrent antifungal medication (e.g., fluconazole or itraconazole)

- No medications that alter cardiac conduction

- No prior Provenge (sipuleucel-T)

Type of Study:


Study Design:

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

Outcome Measure:

Rates of undetectable PSA

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Thomas W. Flaig, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver


United States: Food and Drug Administration

Study ID:




Start Date:

September 2011

Completion Date:

June 2015

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • hormone-resistant prostate cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms



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