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Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients With Castration-Resistant Metastatic Prostate Cancer

Information source: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adenocarcinoma of the Prostate; Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer; Stage IV Prostate Cancer

Intervention: enzalutamide (Drug); abiraterone (Drug); prednisone (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Alliance for Clinical Trials in Oncology

Official(s) and/or principal investigator(s):
Michael Morris, M.D., Study Chair, Affiliation: Memorial Sloan Kettering Cancer Center

Summary

This randomized phase III trial studies enzalutamide to see how well it works compared to enzalutamide, abiraterone, and prednisone in treating patients with castration-resistant metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, abiraterone acetate, and prednisone, may lessen the amount of androgens made by the body.

Clinical Details

Official title: Phase III Trial of Enzalutamide (NSC# 766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall survival (OS)

Secondary outcome:

Grade 3 or higher toxicity profile using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Decline in Prostate Specific Antigen (PSA)

Progression Free Survival (PFS)

Objective response rate

Radiographic Progression Free Survival (rPFS)

Tumor burden and bone activity

Detailed description: Patients are randomized to one of two treatment groups: enzalutamide or enzalutamide, abiraterone and prednisone. Treatment will continue until disease progression or unacceptable toxicity. Patients are followed for clinical outcomes for a maximum of 5 years post study treatment. The primary and secondary objectives are described below. 1. Primary Objective: To compare the overall survival of patients with progressive metastatic castration-resistant prostate cancer (CRPC) treated with either enzalutamide only or enzalutamide with abiraterone and prednisone 2. Secondary Objectives:

- To assess the grade 3 or higher toxicity profile and compare safety by treatment

arm.

- To assess and compare post-treatment prostate-specific antigen (PSA) declines by

treatment arm.

- To compare radiographic progression free survival defined by Prostate Cancer

Working Group 2 (PCWG2), and objective response rate, by treatment arm.

- To test for radiographic progression free survival (rPFS) treatment interaction in

predicting overall survival.

- To assess pre- and post-treatment measures of tumor burden and bone activity using

sodium fluoride (NaF) positron emission tomography (PET)/computed tomography (CT) and technetium (Tc) methylene diphosphonate (MDP) bone scintigraphy and correlate these measures with overall survival.

- To develop and validate prognostic and predictive models of overall survival that

include baseline clinical and molecular markers.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Eligibility Criteria:

1. Documentation of Disease - Progressive castration-resistant metastatic prostate

cancer with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features 2. Patients must have measurable or non-measurable disease:

1. Measurable Disease - For visceral or extra nodal lesions to be considered

measurable, they must be ≥ 10 mm in one dimension, using spiral CT. For lymph nodes to be considered measurable (ie, target or evaluable lesions), they must be ≥ 20 mm in at least one dimension, using spiral CT.

2. Non-Measurable Disease - All other lesions, including small lesions (longest

diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions. Lesions that are considered non-measurable include bone lesions (only). 3. Patients with node only disease (ie, no presence of visceral, extra nodal lesions or bone lesions) must have node(s) that measure ≥ 15 mm in short axis.

3. Progressive Disease - Patients must have progressive disease at study entry defined

as one or more of the following three criteria that occurred while the patient was on androgen deprivation therapy. For patients enrolling on the basis of soft tissue or bone progression, the baseline scan must show progression relative to a comparison scan. If the comparison scan is not available, the baseline scan report must reference the previous scan to document progression. 1. PSA progression defined by a minimum of two rising PSA levels with an interval of ≥ 1 week between each determination. Patients who received an anti-androgen must have progression documented by a minimum of two rising PSA levels with an interval of ≥ 1 week between each determination such that at least the second of these rises is ≥ 4 weeks since last flutamide or ≥ 6 weeks since last bicalutamide or nilutamide. The PSA value at the screening should be ≥ 2 µg/L (2 ng/mL) . 2. Soft tissue disease progression defined by the protocol 3. Bone disease progression defined by the Prostate Cancer Working Group 2 (PCWG2) with two or more new lesions on bone scan 4. Prior Treatment 1. No treatment with prior taxane-based chemotherapy for metastatic disease

- Patients who received prior taxane-based chemotherapy as neoadjuvant or

adjuvant therapy for local disease, or who received taxane-based therapy in the PSA clinical (non-metastatic) state is allowable provided that the total duration of exposure was six cycles or less and chemotherapy was completed more than 6 months prior to registration

- Taxane-based chemotherapy that was aborted due to allergic reactions or

intolerance to chemotherapy and therefore received one cycle of prior therapy is allowable 2. No prior enzalutamide, abiraterone or other novel antiandrogen or androgen synthesis inhibitor 3. No treatment with any of the following for prostate cancer within 4 weeks prior to enrollment:

- Hormonal therapy (e. g., androgen receptor [AR] antagonists, 5 alpha

reductase inhibitors, estrogens) Note: Treatment with bicalutamide and nilutamide within 4 weeks prior to enrollment is not allowed. Treatment with flutamide within 4 weeks prior to enrollment is not allowed. Treatment with all other gonadotropin- releasing hormone (GnRH) analogues or antagonists is allowed.

- Chemotherapy

- Biologic therapy

- Investigational therapy

- Immunotherapy

4. No use of herbal products that may decrease PSA levels within 4 weeks prior to enrollment 5. No use of systemic steroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within 4 weeks prior to enrollment 6. No prior use of ketoconazole for greater than 7 days 7. No prior radiation therapy or radionuclide therapy for the treatment of metastasis within four weeks prior to enrollment 8. Patients receiving bisphosphonate therapy or denosumab must have been on a stable dose for at least 4 weeks prior to enrollment 9. Patients must maintain ongoing androgen deprivation therapy with a GnRH analogue, antagonist, or bilateral orchiectomy (i. e., surgical or medical castration) 5. Patient History 1. No known or suspected brain metastases (NOTE: patients with treated epidural disease are allowed) 2. No planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery 3. No structurally unstable bone lesions suggesting impending fracture 4. No history of seizure or any condition that may increase the patient's seizure risk (e. g., prior cortical stroke, significant brain trauma). No history of transient ischemic attack (TIA) within 12 months of enrollment 5. No clinically significant cardiovascular disease including:

- Myocardial infarction (MI) within 6 months

- Uncontrolled angina within 3 months

- Congestive heart failure (CHF) with New York Heart Association (NYHA) class

3 or 4, or patients with NYHA class 3 or 4 in the past, unless a screening echocardiogram (echo) or multigated acquisition scan (MUGA) performed within three months demonstrates an ejection fraction (EF) > 45%

- History of clinically significant ventricular arrhythmias (e. g.,

ventricular tachycardia, ventricular fibrillation, torsades de pointes)

- History of Mobitz II second degree or third degree heart block without a

permanent pacemaker in place

- Hypotension (systolic blood pressure [BP] < 86 mmHg) or bradycardia (< 50

bpm) at screening

- Uncontrolled hypertension (systolic BP > 170 mmHg or diastolic BP > 105

mmHg at screening) 6. No gastrointestinal (GI) disorder that negatively affects absorption 7. No major surgery within 4 weeks prior to enrollment 6. Age and performance status 1. Age ≥ 18 years of age 2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 3. Asymptomatic or mildly symptomatic from prostate cancer 7. Required Initial Laboratory Values 1. Granulocytes ≥ 1,500/µL 2. Platelet count ≥ 100,000/µL 3. Hemoglobin ≥ 9 g/dL 4. Creatinine ≤ 2 x upper limits of normal (ULN) 5. Bilirubin ≤ 1. 5 x ULN 6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2 x ULN 7. Albumin ≥ 3 g/dl 8. Serum testosterone ≤ 50 ng/dL (1. 7 nmol/L)

Locations and Contacts

UC San Diego Moores Cancer Center, La Jolla, California 92093, United States; Recruiting
James Randall, M.D., Phone: 858-822-6185

UCSF - Mount Zion, San Francisco, California 94115, United States; Recruiting
Terence Friedlander, M.D., Phone: 415-514-8481

The Shaw Regional Cancer Center, Edwards, Colorado 81632, United States; Recruiting
Alexander Urquhart, M.D., Phone: 970-569-7684

Saint Francis Hospital and Medical Center, Hartford, Connecticut 06105, United States; Recruiting
Philip Stella, M.D., Phone: 734-712-4931

Mount Sinai Medical Center CCOP, Miami Beach, Florida 33140, United States; Recruiting
Michael Schwartz, M.D., Phone: 305-674-2625

Sacred Heart Hospital, Pensacola, Florida 32504, United States; Recruiting
James Watkins, M.D., Phone: 850-416-6933

Sacred Heart Medical Oncology Group - Davis Highway, Pensacola, Florida 32514, United States; Recruiting
James Watkins, M.D., Phone: 850-416-6933

Illinois Cancer Care - Peoria, Peoria, Illinois 61615, United States; Recruiting
Nguyet Le-Lindqwister, M.D., Phone: 309-672-5681

Quincy Medical Group - Clinic, Quincy, Illinois 62301, United States; Recruiting
Raymond Smith, M.D., Phone: 217-277-3500

Michiana Hematology Oncology PC-Mishawaka, Mishawaka, Indiana 46545, United States; Recruiting
Robin Zon, M.D., Phone: 574-647-6343

Michiana Hematology Oncology-PC Westville, Westville, Indiana 46391, United States; Recruiting
Robin Zon, Phone: 574-647-6343

Hematology Oncology Associates - Quad Cities, Bettendorf, Iowa 52722, United States; Recruiting
Shobha Chitneni, M.D., Phone: 563-355-7733

Genesis Medical Center - East Campus, Davenport, Iowa 52803, United States; Recruiting
George Kovach, M.D., Phone: 563-421-1960

University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States; Recruiting
Daniel Vaena, M.D., Phone: 319-356-3944

VA Medical Center - University of Iowa, Iowa City, Iowa 52246, United States; Recruiting
Daniel Vaena, M.D., Phone: 319-356-3944

Harold Alfond Center for Cancer Care, Augusta, Maine 04330, United States; Recruiting
Thomas H. Openshaw, M.D., Phone: 207-621-6100

Eastern Maine Medical Center, Bangor, Maine 04401, United States; Recruiting
Thomas Openshaw, M.D., Phone: 207-973-7474

Frederick Memorial Hospital, Frederick, Maryland 21701, United States; Recruiting
Elhamy Eskander, M.D., Phone: 301-662-8477

Saint Joseph Mercy Hospital, Ann Arbor, Michigan 48106, United States; Recruiting
Philip J. Stella, Phone: 734-712-5947

Henry Ford Hospital, Detroit, Michigan 48202, United States; Recruiting
Robert Chapman, M.D., Phone: 313-916-1784

Green Bay Oncology - Escanaba, Escanaba, Michigan 49431, United States; Recruiting
Anthony J. Jaslowski, Phone: 610-402-2273

Green Bay Oncology - Iron Mountain, Iron Mountain, Michigan 49801, United States; Recruiting
Anthony J. Jaslowski, Phone: 610-402-2273

Saint Mary Mercy Hospital, Livonia, Michigan 48154, United States; Recruiting
Philip J. Stella, Phone: 610-402-2273

Saint Mary's of Michigan, Saginaw, Michigan 48601, United States; Recruiting
Philip J. Stella, Phone: 610-402-2273

Mercy Hospital, Coon Rapids, Minnesota 55433, United States; Recruiting
Daniel Anderson, M.D., Phone: 952-993-1517

Essentia Health Duluth Clinic CCOP, Duluth, Minnesota 55805, United States; Recruiting
Bret Friday, M.D., Phone: 218-786-3625

Minneapolis Veterans Medical Center, Minneapolis, Minnesota 55417, United States; Recruiting
Sharon Luikart, MD, Phone: 612-467-4134

Park Nicollet Cancer Center, Saint Louis Park, Minnesota 55416, United States; Recruiting
Daniel M. Anderson, Phone: 952-993-3248

Saint Francis Regional Medical Center, Shakopee, Minnesota 55379, United States; Recruiting
Daniel Anderson, M.D., Phone: 952-993-1517

Lakeview Hospital, Stillwater, Minnesota 55082, United States; Recruiting
Daniel M. Anderson, Phone: 651-439-1517

Saint Francis Medical Center, Cape Giradeau, Missouri 63703, United States; Recruiting
James Wade, M.D., Phone: 217-876-6600

Saint Luke's Hospital, Chesterfield, Missouri 63017, United States; Recruiting
Donald Busiek, M.D., Phone: 314-205-6737

University of Missouri - Ellis Fischel, Columbia, Missouri 65203, United States; Recruiting
Donald Doll, M.D., Phone: 573-882-6964

Missouri Baptist Medical Center, Saint Louis, Missouri 63131, United States; Recruiting
Alan P. Lyss, Phone: 610-402-2273

Washington University School of Medicine, Saint Louis, Missouri 63110, United States; Recruiting
Joel Picus, M.D., Phone: 314-362-5740

Mercy Hospital - Springfield, Springfield, Missouri 65804, United States; Recruiting
Jay Carlson, M.D., Phone: 417-820-3554

Saint Vincent Healthcare, Billings, Montana 59101, United States; Recruiting
Benjamin Marchello, M.D., Phone: 406-238-6290

Bozeman Deaconess Cancer Center, Bozeman, Montana 59715, United States; Recruiting
Benjamin T. Marchello, MD, Phone: 406-238-6290

Nebraska Methodist Hospital, Omaha, Nebraska 68114, United States; Recruiting
Ralph Hauke, M.D., Phone: 402-991-8070

HealthCare Partners Medical Group Oncology/Hematology-San Martin, Las Vegas, Nevada 89113, United States; Recruiting
John Ellerton, M.D., Phone: 702-822-2000

HealthCare Partners Medical Group Oncology/Hematology-Tenaya, Las Vegas, Nevada 89128, United States; Recruiting
John Ellerton, M.D., Phone: 702-822-2000

New Hampshire Oncology - Hematology PA, Concord, New Hampshire 03301, United States; Recruiting
Frederick Briccetti, M.D., Phone: 603-552-9170

Wentworth Douglass Hospital, Dover, New Hampshire 03820, United States; Recruiting
Taylor Ortiz, M.D., Phone: 603-742-8787

New Hampshire Oncology Hematology Associates, Hooksett, New Hampshire 03106, United States; Recruiting
Frederick Briccetti, M.D., Phone: 603-552-9170

LRGHealthcare-Lakes Region General Hospital, Laconia, New Hampshire 03246, United States; Recruiting
Frederick Briccetti, M.D., Phone: 603-552-9170

University of New Mexico, Albuquerque, New Mexico 87106, United States; Recruiting
Richard Lauer, M.D., Phone: 505-925-0478

Memorial Medical Center-Las Cruces, Las Cruces, New Mexico 88011, United States; Recruiting
Richard Lauer, M.D., Phone: 505-925-0478

Christus Saint Vincent Regional Cancer Center, Santa Fe, New Mexico 87505, United States; Recruiting
Richard Lauer, M.D., Phone: 505-925-0478

Maimonides Medical Center, Brooklyn, New York 11219, United States; Recruiting
Kevin Becker, M.D., Phone: 718-765-2600

Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States; Recruiting
Michael J. Morris, Phone: 212-639-2000

Randolph Hospital, Asheboro, North Carolina 27203, United States; Recruiting
James Granfortuna, M.D., Phone: 336-832-1100

Core Health Cancer Center, Greensboro, North Carolina 27403, United States; Recruiting
James Granfortuna, M.D., Phone: 336-832-1100

Annie Penn Memorial Hospital, Reidsville, North Carolina 27320, United States; Recruiting
James Granfortuna, M.D., Phone: 336-832-1100

Marion L. Shepard Cancer Center at Beaufort County Hospital, Washington, North Carolina 27889, United States; Recruiting
John J. Inzerillo, Phone: 252-975-4308

Sanford Bismarck Medical Center, Bismarck, North Dakota 58501, United States; Recruiting
Preston Steen, M.D., Phone: 701-234-6161

Sanford Clinic North-Fargo, Fargo, North Dakota 58102, United States; Recruiting
Preston Steen, M.D., Phone: 701-234-6161

Sanford Medical Center-Fargo, Fargo, North Dakota 58122, United States; Recruiting
Preston Steen, M.D., Phone: 701-234-6161

Case Western Reserve University, Cleveland, Ohio 44106, United States; Recruiting
Matthew Cooney, M.D., Phone: 216-844-7048

Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States; Recruiting
Anjali Advani, M.D., Phone: 216-445-9354

Cancer Centers of Southwest Oklahoma, LLC - Lawton, Lawton, Oklahoma 73505, United States; Recruiting
Nadim F. Nimeh, MD, Phone: 580-536-2121, Ext: 113

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States; Recruiting
Sindhu Singh, M.D., Phone: 405-271-8777

Good Samaritan Hospital, Corvallis, Oregon 97330, United States; Recruiting
Kimberly McGregor, M.D., Phone: 541-768-4771

Kaiser Permanente Health Care - Portland, Portland, Oregon 97232, United States; Recruiting
Nagendra Tirumali, MD, Phone: 503-331-6500

Adams Cancer Center, Gettysburg, Pennsylvania 17325, United States; Recruiting
Amir Tabatabai, M.D., Phone: 717-741-8124

WellSpan Health-York Hospital, York, Pennsylvania 17405, United States; Recruiting
Amir Tabatabai, M.D., Phone: 717-741-9229

Sanford Cancer Center Oncology Clinic, Sioux Falls, South Dakota 57104, United States; Recruiting
Miroslaw Mazurczak, Phone: 605-328-8000

Virginia Commonwealth University, Richmond, Virginia 23298, United States; Recruiting
Craig Swainey, M.D., Phone: 804-828-9723

PeaceHealth Saint Joseph Medical Center, Bellingham, Washington 98225, United States; Recruiting
Gary Goodman, M.D., Phone: 206-386-2122

Harrison Health Partners Hematology and Oncology - Poulsbo, Poulsbo, Washington 98370, United States; Recruiting
Gary Goodman, M.D., Phone: 206-386-2122

Saint Mary's Medical Center, Huntington, West Virginia 25702, United States; Recruiting
Arvinder Bir, M.D., Phone: 304-528-4658

Green Bay Oncology at Saint Vincent Hospital, Green Bay, Wisconsin 54301-3526, United States; Recruiting
Anthony J. Jaslowski, Phone: 610-402-2273

Saint Mary's Hospital, Green Bay, Wisconsin 54303, United States; Recruiting
Anthony J. Jaslowski, Phone: 610-402-2273

Saint Vincent Hospital, Green Bay, Wisconsin 54301, United States; Recruiting
Anthony Jaslowski, M.D., Phone: 920-884-3135

Holy Family Memorial Hospital, Manitowoc, Wisconsin 54221, United States; Recruiting
Anthony J. Jaslowski, Phone: 610-402-2273

Marshfield Clinic, Marshfield, Wisconsin 54449, United States; Recruiting
Seth Fagbemi, M.D., Phone: 715-387-5426

Saint Joseph's Hospital, Marshfield, Wisconsin 54449, United States; Recruiting
Seth O. Fagbemi, MD, Phone: 715-387-5426

Green Bay Oncology - Oconto Falls, Oconto Falls, Wisconsin 54154, United States; Recruiting
Anthony J. Jaslowski, Phone: 610-402-2273

Saint Nicholas Hospital, Sheboygan, Wisconsin 53081, United States; Recruiting
Anthony Jaslowski, M.D., Phone: 920-884-3135

Marshfield Clinic at Saint Michael's Hospital, Stevens Point, Wisconsin 54481, United States; Recruiting
Seth O. Fagbemi, MD, Phone: 715-387-5426

Saint Michael's Hospital Cancer Center, Stevens Point, Wisconsin 54481, United States; Recruiting
Seth O. Fagbemi, MD, Phone: 715-387-5426

Green Bay Oncology - Sturgeon Bay, Sturgeon Bay, Wisconsin 54235, United States; Recruiting
Anthony J. Jaslowski, Phone: 610-402-2273

Diagnostic and Treatment Center, Weston, Wisconsin 54476, United States; Recruiting
Seth Fagbemi, M.D., Phone: 715-387-5426

Marshfield Clinic - Weston Center, Weston, Wisconsin 54476, United States; Recruiting
Seth Fagbemi, M.D., Phone: 715-387-5426

Additional Information

Starting date: January 2014
Last updated: April 6, 2015

Page last updated: August 23, 2015

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