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S1014 Abiraterone Acetate in ...

S1014 Abiraterone Acetate in Treating Patients With Prostate Cancer Who Have Undergone Initial Hormone Therapy

Last Updated: 2025-02-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-09

Study Completion Date

2024-04-11

Brief Summary

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RATIONALE: Androgens can cause the growth of prostate cancer cells. Antiandrogen drugs, such as abiraterone acetate, may lessen the amount of androgens made by the body. It may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying the side effects and how well abiraterone acetate works in treating patients with prostate cancer who have undergone initial hormone therapy.

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Detailed Description

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OBJECTIVES:

Primary

* 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).

Secondary

* To assess the overall survival and objective progression-free survival of this group of patients.
* 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 acceptable.

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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Abiraterone acetate + prednisone

Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily

Prednisone, 5 mg, oral, 5 mg twice daily

Group Type EXPERIMENTAL

abiraterone acetate

Intervention Type DRUG

1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily

Prednisone

Intervention Type DRUG

5 mg, oral, 5 mg twice daily

Interventions

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abiraterone acetate

1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily

Intervention Type DRUG

Prednisone

5 mg, oral, 5 mg twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 washout)
* 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 registration
* 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

PATIENT CHARACTERISTICS:

* 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 registration
* 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

PRIOR CONCURRENT THERAPY:

* 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 cancer
* 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas W. Flaig, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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NEA Medical Clinic - East Matthews

Jonesboro, Arkansas, United States

Site Status

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Highlands Oncology Group - Springdale

Rogers, Arkansas, United States

Site Status

Kaiser Permanente - Deer Valley

Antioch, California, United States

Site Status

Kaiser Permanente - Fremont

Fremont, California, United States

Site Status

Kaiser Permanente Fresno Medical Center

Fresno, California, United States

Site Status

Kaiser Permanente Medical Center - Hayward

Hayward, California, United States

Site Status

Tibotec Therapeutics - Division of Ortho Biotech Products, LP

Marysville, California, United States

Site Status

Kaiser Permanente Medical Center - Oakland

Oakland, California, United States

Site Status

Kaiser Permanente Medical Center - Redwood City

Redwood City, California, United States

Site Status

Kaiser Permanente Medical Center - Richmond

Richmond, California, United States

Site Status

Kaiser Permanente Medical Center - Roseville

Roseville, California, United States

Site Status

University of California Davis Cancer Center

Sacramento, California, United States

Site Status

South Sacramento Kaiser-Permanente Medical Center

Sacramento, California, United States

Site Status

Kaiser Permanente Medical Center - Sacramento

Sacramento, California, United States

Site Status

Kaiser Permanente Medical Center - San Francisco Geary Campus

San Francisco, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Teresa

San Jose, California, United States

Site Status

Kaiser Foundation Hospital - San Rafael

San Rafael, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Clara Kiely Campus

Santa Clara, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Rosa

Santa Rosa, California, United States

Site Status

Kaiser Permanente Medical Center - South San Francisco

South San Francisco, California, United States

Site Status

Kaiser Permanente Medical Facility - Stockton

Stockton, California, United States

Site Status

Tahoe Forest Cancer Center

Truckee, California, United States

Site Status

Kaiser Permanente Medical Center - Vacaville

Vacaville, California, United States

Site Status

Kaiser Permanente Medical Center - Vallejo

Vallejo, California, United States

Site Status

Kaiser Permanente Medical Center - Walnut Creek

Walnut Creek, California, United States

Site Status

San Luis Valley Regional Medical Center

Alamosa, Colorado, United States

Site Status

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, United States

Site Status

Memorial Hospital Cancer Center - Colorado Springs

Colorado Springs, Colorado, United States

Site Status

Shaw Regional Cancer Center

Edwards, Colorado, United States

Site Status

Poudre Valley Hospital

Fort Collins, Colorado, United States

Site Status

Front Range Cancer Specialists

Fort Collins, Colorado, United States

Site Status

Valley View Hospital Cancer Center

Glenwood Springs, Colorado, United States

Site Status

St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

Grand Junction, Colorado, United States

Site Status

Montrose Memorial Hospital Cancer Center

Montrose, Colorado, United States

Site Status

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Site Status