Abiraterone Acetate and Antiandrogen Therapy With or Without Cabazitaxel and Prednisone in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer Previously Treated With Docetaxel
Castration Levels of TestosteroneCastration-Resistant Prostate CarcinomaMetastatic Prostate Carcinoma in the Soft TissueProstate Carcinoma Metastatic in the BoneStage IV Prostate Adenocarcinoma AJCC v7
Androgen deprivation therapy: Receive standard of care antiandrogen therapy with either LHRH agonist or antagonist or surgical castration with bilateral orchiectomy.
Cabazitaxel: Given IV
Prednisone: Given PO
Study summary
This randomized phase II trial studies how well abiraterone acetate and antiandrogen therapy, with or without cabazitaxel and prednisone, work in treating patients with castration-resistant prostate cancer previously treated with docetaxel that has spread to other parts of the body. Androgens can cause the growth of prostate cancer cells. Hormone therapy using abiraterone acetate and antiandrogen therapy may fight prostate cancer by lowering and/or blocking the use of androgens by the tumor cells. Drugs used in chemotherapy, such as cabazitaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving abiraterone acetate and antiandrogen therapy with or without cabazitaxel and prednisone may help kill more tumor cells.
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Histologically confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate)
* Previous chemotherapy with at least 3 cycles of docetaxel for hormone-sensitive metastatic prostate cancer
* Metastatic disease as evidenced by the presence of soft tissue and/or bone metastases on imaging studies (CT/magnetic resonance imaging \[MRI\] of abdomen/pelvis, bone scintigraphy or NaF PET/CT)
* Ability to swallow abiraterone acetate tablets as a whole
* All patients must be receiving standard of care androgen deprivation treatment (surgical castration versus LHRH agonist or antagonist treatment); subjects receiving LHRH agonist or antagonist must continue treatment throughout the time on this study
* Patients must have castrate serum level of testosterone of \< 50 ng/dL (\< 1.73 nmol/L)
* Patients must have progressive disease while receiving androgen deprivation therapy defined by any one of the following as per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria for PSA, measurable disease or non-measurable (bone) disease during treatment with ADT:
* PSA: At least two consecutive rises in serum PSA, obtained at a minimum of 1-week intervals, with the final value \>= 1.0 ng/mL, confirmed \<=4 weeks prior to randomization
* Measurable disease (by RECIST 1.1): \> 20% increase in the sum of the longest diameters of all measurable lesions or the development of new measurable lesions; the short axis of a target lymph node must be more than 15 mm to be assessed for change in size
* Non-measurable (bone) disease: The appearance of two or more new areas of uptake on bone scan (or NaF PET/CT) consistent with metastatic disease compared to previous imaging during castration therapy; the increased uptake of pre-existing lesions on bone scan will not be taken to constitute progression, and ambiguous results must be confirmed by other imaging modalities (e.g. X-ray, CT or MRI). Clinical decisions about response or progression will be based on CT and bone scans.
* Patients may or may not have been treated previously with a nonsteroidal antiandrogen, such as flutamide, bicalutamide or nilutamide; for patients previously treated with an antiandrogen, they must be off treatment for at least 4 weeks (for flutamide) or 6 weeks (for bicalutamide or nilutamide) prior to registration and must have shown PSA progression after discontinuing the anti-androgen
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Absolute neutrophil count (ANC) \>= 1500/mm\^3
* Hemoglobin (HgB) \>= 9.0 gr/dL
* Platelets \>= 100,000/mm\^3
* Creatinine \< 2.0 mg/dL
* Patients must be informed of the experimental nature of the study and its potential risks, and must sign an Institutional Review Board (IRB)-approved written informed consent form indicating such an understanding
* Patients with resected or irradiated brain metastases or those treated with stereotactic radiation therapy are eligible to enroll, provided that they do not require treatment with steroids that exceeds 10 mg of prednisone daily or equivalent
* Sexually active males must use an accepted and effective method of double barrier contraception or abstain from sexual intercourse for the duration of their participation in the study and for 26 weeks after the last dose of study drug
* NaF PET/CT OPTIONAL SUB-STUDY ELIGIBILITY CRITERIA
* Ability to lie still for imaging
* Weight =\< 300 lbs (pounds)
* Metastatic disease confined predominantly to the bones
Exclusion Criteria:
* Any prior chemotherapy or androgen receptor (AR)-directed therapy for CRPC, (e.g. docetaxel, cabazitaxel, mitoxantrone, abiraterone acetate, ketoconazole, or enzalutamide); previous treatment with radium-223 or sipuleucel-T is allowed
* Pure small cell or other variant (non-adenocarcinoma) prostate cancer histology for which treatment with abiraterone would not be considered appropriate
* Patients may not be receiving other therapeutic investigational agents or be receiving concurrent anticancer therapy other than standard androgen deprivation therapy; concurrent treatment with agents to prevent skeletal-related events (such as zoledronic acid or denosumab) will be allowed as long as it was initiated prior to study entry or there are plans to initiate it after cycle 2 day 1.
* Any medical condition for which prednisone (corticosteroid) is contraindicated
* Total bilirubin \> upper limit of normal (ULN) (NOTE: in subjects with Gilbert's syndrome, if total bilirubin is \> ULN, measure direct and indirect bilirubin and if direct bilirubin is within normal range, subject may be eligible)
* Alanine (ALT) or aspartate (AST) aminotransferase \> 1.5 x ULN
* Active infection requiring treatment with antibiotics
* History of adrenal insufficiency or hypoaldosteronism
* Myocardial infarction or arterial thrombotic event within 6 months of randomization, heart failure of New York Heart Association class II or higher, uncontrolled angina, severe uncontrolled ventricular arrhythmia
* External beam radiation therapy within 2 weeks of registration
* Prior history of allergic reactions to G-CSF
* Prior history of allergic reactions to docetaxel and/or to medications formulated with polysorbate 80
* History of active malignancy; patients with a history of cancer that has been adequately treated and are free of disease recurrence for 3 years or more are allowed to participate; patients with non-melanoma skin cancers or carcinoma in situ of the bladder that have been adequately excised are eligible to participate
* Life expectancy of \< 12 months at screening
* Grade \>= 2 neuropathy
* Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg). Patients with a history of hypertension are allowed to enroll provided blood pressure is controlled with anti-hypertensive treatment
Primary outcome measure(s)
Progression-free Survival (PFS) — Assessed every 9 weeks for the first 18 weeks, then every 12 weeks until treatment discontinuation; if treatment discontinued prior to radiographic progression, then every 3 months until radiographic progression, up to 5 years PFS is defined as time from randomization to radiographic progression, symptomatic deterioration requiring discontinuation of treatment or death, whichever occurs first. Patients who died without documented radiographic progression or symptomatic deterioration and the death occurred more than 6.5 months after the date of last disease assessment were censored at the date of last disease assessment.
Trial sites (672)
Facility
City
Region
Status
Fairbanks Memorial Hospital
Fairbanks
Alaska
CTCA at Western Regional Medical Center
Goodyear
Arizona
Kingman Regional Medical Center
Kingman
Arizona
Mercy Hospital Fort Smith
Fort Smith
Arkansas
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs
Arkansas
Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro
Arkansas
John L McClellan Memorial Veterans Hospital
Little Rock
Arkansas
Kaiser Permanente-Deer Valley Medical Center
Antioch
California
PCR Oncology
Arroyo Grande
California
Sutter Auburn Faith Hospital
Auburn
California
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn
California
Alta Bates Summit Medical Center-Herrick Campus
Berkeley
California
Mills-Peninsula Medical Center
Burlingame
California
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park
California
Eden Hospital Medical Center
Castro Valley
California
Adventist Health Cancer Care Center Chico
Chico
California
Sutter Davis Hospital
Davis
California
Epic Care-Dublin
Dublin
California
Kaiser Permanente Dublin
Dublin
California
Bay Area Breast Surgeons Inc
Emeryville
California
Epic Care Partners in Cancer Care
Emeryville
California
Palo Alto Medical Foundation-Fremont
Fremont
California
Contra Costa Regional Medical Center
Martinez
California
Memorial Medical Center
Modesto
California
Palo Alto Medical Foundation-Camino Division
Mountain View
California
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View
California
Sutter Cancer Research Consortium
Novato
California
Alta Bates Summit Medical Center - Summit Campus
Oakland
California
Bay Area Tumor Institute
Oakland
California
Palo Alto Medical Foundation Health Care
Palo Alto
California
VA Palo Alto Health Care System
Palo Alto
California
Kaiser Permanente-Redwood City
Redwood City
California
Kaiser Permanente-Richmond
Richmond
California
Kaiser Permanente-Roseville
Roseville
California
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville
California
Sutter Roseville Medical Center
Roseville
California
Kaiser Permanente Downtown Commons
Sacramento
California
Sutter Medical Center Sacramento
Sacramento
California
Kaiser Permanente-South Sacramento
Sacramento
California
Kaiser Permanente - Sacramento
Sacramento
California
+ 632 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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