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ACTIVE NOT RECRUITING

NCT03419234

PHASE2

Abiraterone Acetate and Antiandrogen Therapy With or Without Cabazitaxel and Prednisone in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer Previously Treated With Docetaxel

Sponsor: ECOG-ACRIN Cancer Research Group

View on ClinicalTrials.gov

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.

Official title: Cabazitaxel With Abiraterone Versus Abiraterone Alone Randomized Trial for Extensive Disease Following Docetaxel: The CHAARTED2 Trial

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

223

Start Date

2018-04-26

Completion Date

2028-04-01

Last Updated

2026-10-06

Healthy Volunteers

Conditions

Castration Levels of Testosterone Castration-Resistant Prostate Carcinoma Metastatic Prostate Carcinoma in the Soft Tissue Prostate Carcinoma Metastatic in the Bone Stage IV Prostate Adenocarcinoma AJCC v7

Interventions

DRUG

Abiraterone Acetate

Given PO

DRUG

Androgen deprivation therapy

Receive standard of care antiandrogen therapy with either LHRH agonist or antagonist or surgical castration with bilateral orchiectomy.

DRUG

Cabazitaxel

Given IV

DRUG

Prednisone

Given PO

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

Locations (672)

Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

CTCA at Western Regional Medical Center

Goodyear, Arizona, United States

Kingman Regional Medical Center

Kingman, Arizona, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

CHI Saint Vincent Cancer Center Hot Springs

Hot Springs, Arkansas, United States

Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

John L McClellan Memorial Veterans Hospital

Little Rock, Arkansas, United States

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, United States

PCR Oncology

Arroyo Grande, California, United States

Sutter Auburn Faith Hospital

Auburn, California, United States

Sutter Cancer Centers Radiation Oncology Services-Auburn

Auburn, California, United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Mills-Peninsula Medical Center

Burlingame, California, United States

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, United States

Eden Hospital Medical Center

Castro Valley, California, United States

Adventist Health Cancer Care Center Chico

Chico, California, United States

Sutter Davis Hospital

Davis, California, United States

Epic Care-Dublin

Dublin, California, United States

Kaiser Permanente Dublin

Dublin, California, United States

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Epic Care Partners in Cancer Care

Emeryville, California, United States

Palo Alto Medical Foundation-Fremont

Fremont, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Memorial Medical Center

Modesto, California, United States

Palo Alto Medical Foundation-Camino Division

Mountain View, California, United States

Palo Alto Medical Foundation-Gynecologic Oncology

Mountain View, California, United States

Sutter Cancer Research Consortium

Novato, California, United States

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Bay Area Tumor Institute

Oakland, California, United States

Palo Alto Medical Foundation Health Care

Palo Alto, California, United States

VA Palo Alto Health Care System

Palo Alto, California, United States

Kaiser Permanente-Redwood City

Redwood City, California, United States

Kaiser Permanente-Richmond

Richmond, California, United States

Kaiser Permanente-Roseville

Roseville, California, United States

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, United States

Sutter Roseville Medical Center

Roseville, California, United States

Kaiser Permanente Downtown Commons

Sacramento, California, United States

Sutter Medical Center Sacramento

Sacramento, California, United States

Kaiser Permanente-South Sacramento

Sacramento, California, United States

Kaiser Permanente - Sacramento

Sacramento, California, United States

California Pacific Medical Center-Pacific Campus

San Francisco, California, United States

Kaiser Permanente-San Francisco

San Francisco, California, United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Kaiser Permanente-San Rafael

San Rafael, California, United States

Kaiser San Rafael-Gallinas

San Rafael, California, United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Palo Alto Medical Foundation-Santa Cruz

Santa Cruz, California, United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Sutter Pacific Medical Foundation

Santa Rosa, California, United States

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Kaiser Permanente-Stockton

Stockton, California, United States

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, United States

Sutter Cancer Centers Radiation Oncology Services-Vacaville

Vacaville, California, United States

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, United States

Kaiser Permanente-Vallejo

Vallejo, California, United States

Sutter Solano Medical Center/Cancer Center

Vallejo, California, United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

Epic Care Cyberknife Center

Walnut Creek, California, United States

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

The Medical Center of Aurora

Aurora, Colorado, United States

Boulder Community Hospital

Boulder, Colorado, United States

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Cancer Center of Colorado at Sloan's Lake