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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborators:
Astellas Pharma US, Inc.
Medivation, Inc.
Biologics, Inc.
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01949337
First received: September 20, 2013
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

This randomized phase III trial studies enzalutamide to see how well it works compared to enzalutamide, abiraterone acetate, 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.


Condition Intervention Phase
Adenocarcinoma of the Prostate
Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Drug: enzalutamide
Drug: abiraterone
Drug: prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Trial of Enzalutamide (NSC# 766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Overall survival (OS) [ Time Frame: Up to 5 years post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Grade 3 or higher toxicity profile using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 5 years post treatment ] [ Designated as safety issue: Yes ]
  • Decline in Prostate Specific Antigen (PSA) [ Time Frame: Up to 5 years post treatment ] [ Designated as safety issue: Yes ]
  • Progression Free Survival (PFS) [ Time Frame: Up to 5 years post treatment ] [ Designated as safety issue: No ]
  • Objective response rate [ Time Frame: Up to 5 years post treatment ] [ Designated as safety issue: No ]
  • Radiographic Progression Free Survival (rPFS) [ Time Frame: Up to 5 years post treatment ] [ Designated as safety issue: No ]
  • Tumor burden and bone activity [ Time Frame: Up to 5 years post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 1224
Study Start Date: January 2014
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: (enzalutamide)
Patients receive enzalutamide 160 mg PO QD. Treatment will continue until confirmed disease progression or unacceptable toxicity.
Drug: enzalutamide
Enzalutamide 160 mg daily, orally
Experimental: Arm B: (enzalutamide, abiraterone acetate, prednisone)
Patients receive enzalutamide 160 mg PO QD, abiraterone acetate 1000 mg PO QD, and prednisone 5 mg PO BID. Treatment will continue until confirmed disease progression or unacceptable toxicity.
Drug: enzalutamide
Enzalutamide 160 mg daily, orally
Drug: abiraterone
abiraterone 1000 mg daily, orally
Drug: prednisone
prednisone 5 mg twice daily, orally

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 (abiraterone acetate) 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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. 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 6 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01949337

  Hide Study Locations
Locations
United States, California
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: James Randall, M.D.    858-822-6185      
UCSF - Mount Zion Recruiting
San Francisco, California, United States, 94115
Contact: Terence Friedlander, M.D.    415-514-8481      
United States, Colorado
The Shaw Regional Cancer Center Recruiting
Edwards, Colorado, United States, 81632
Contact: Alexander Urquhart, M.D.    970-569-7684      
United States, Connecticut
Saint Francis Hospital and Medical Center Recruiting
Hartford, Connecticut, United States, 06105
Contact: Philip Stella, M.D.    734-712-4931      
United States, Florida
Mount Sinai Medical Center CCOP Recruiting
Miami Beach, Florida, United States, 33140
Contact: Michael Schwartz, M.D.    305-674-2625      
Sacred Heart Hospital Recruiting
Pensacola, Florida, United States, 32504
Contact: James Watkins, M.D.    850-416-6933      
Sacred Heart Medical Oncology Group - Davis Highway Recruiting
Pensacola, Florida, United States, 32514
Contact: James Watkins, M.D.    850-416-6933      
United States, Illinois
Illinois Cancer Care - Peoria Recruiting
Peoria, Illinois, United States, 61615
Contact: Nguyet Le-Lindqwister, M.D.    309-672-5681      
Quincy Medical Group - Clinic Recruiting
Quincy, Illinois, United States, 62301
Contact: Raymond Smith, M.D.    217-277-3500      
United States, Indiana
Michiana Hematology Oncology PC-Mishawaka Recruiting
Mishawaka, Indiana, United States, 46545
Contact: Robin Zon, M.D.    574-647-6343      
Michiana Hematology Oncology-PC Westville Recruiting
Westville, Indiana, United States, 46391
Contact: Robin Zon    574-647-6343      
United States, Iowa
Hematology Oncology Associates - Quad Cities Recruiting
Bettendorf, Iowa, United States, 52722
Contact: Shobha Chitneni, M.D.    563-355-7733      
Genesis Medical Center - East Campus Recruiting
Davenport, Iowa, United States, 52803
Contact: George Kovach, M.D.    563-421-1960      
VA Medical Center - University of Iowa Recruiting
Iowa City, Iowa, United States, 52246
Contact: Daniel Vaena, M.D.    319-356-3944      
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Daniel Vaena, M.D.    319-356-3944      
United States, Maine
Harold Alfond Center for Cancer Care Recruiting
Augusta, Maine, United States, 04330
Contact: Thomas H. Openshaw    207-621-6100      
Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04401
Contact: Thomas Openshaw, M.D.    207-973-7474      
United States, Maryland
Frederick Memorial Hospital Recruiting
Frederick, Maryland, United States, 21701
Contact: Elhamy Eskander, M.D.    301-662-8477      
United States, Michigan
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Philip J. Stella    734-712-5947      
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Robert Chapman, M.D.    313-916-1784      
Green Bay Oncology - Escanaba Recruiting
Escanaba, Michigan, United States, 49431
Contact: Anthony J. Jaslowski    610-402-2273      
Green Bay Oncology - Iron Mountain Recruiting
Iron Mountain, Michigan, United States, 49801
Contact: Anthony J. Jaslowski    610-402-2273      
Saint Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
Contact: Philip J. Stella    610-402-2273      
Saint Mary's of Michigan Recruiting
Saginaw, Michigan, United States, 48601
Contact: Philip J. Stella    610-402-2273      
United States, Minnesota
Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Daniel Anderson, M.D.    952-993-1517      
Essentia Health Duluth Clinic CCOP Recruiting
Duluth, Minnesota, United States, 55805
Contact: Bret Friday, M.D.    218-786-3625      
Park Nicollet Cancer Center Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Daniel M. Anderson    952-993-3248      
Saint Francis Regional Medical Center Recruiting
Shakopee, Minnesota, United States, 55379
Contact: Daniel Anderson, M.D.    952-993-1517      
Lakeview Hospital Recruiting
Stillwater, Minnesota, United States, 55082
Contact: Daniel M. Anderson    651-439-1517      
United States, Missouri
Saint Francis Medical Center Recruiting
Cape Giradeau, Missouri, United States, 63703
Contact: James Wade, M.D.    217 876-6600      
Saint Luke's Hospital Recruiting
Chesterfield, Missouri, United States, 63017
Contact: Donald Busiek, M.D.    314-205-6737      
University of Missouri - Ellis Fischel Recruiting
Columbia, Missouri, United States, 65203
Contact: Donald Doll, M.D.    573-882-6964      
Missouri Baptist Medical Center Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Alan P. Lyss    610-402-2273      
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Joel Picus, M.D.    314-362-5740      
Mercy Hospital - Springfield Recruiting
Springfield, Missouri, United States, 65804
Contact: Jay Carlson, M.D.    417-820-3554      
United States, Montana
Saint Vincent Healthcare Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin Marchello, M.D.    406-238-6290      
Bozeman Deaconess Cancer Center Recruiting
Bozeman, Montana, United States, 59715
Contact: Benjamin T. Marchello, MD    406-238-6290      
United States, Nebraska
Nebraska Methodist Hospital Recruiting
Omaha, Nebraska, United States, 68114
Contact: Ralph Hauke, M.D.    402-991-8070      
United States, Nevada
HealthCare Partners Medical Group Oncology/Hematology-Tenaya Recruiting
Las Vegas, Nevada, United States, 89128
Contact: John Ellerton, M.D.    702-822-2000      
HealthCare Partners Medical Group Oncology/Hematology-San Martin Recruiting
Las Vegas, Nevada, United States, 89113
Contact: John Ellerton, M.D.    702-822-2000      
United States, New Hampshire
New Hampshire Oncology - Hematology PA Recruiting
Concord, New Hampshire, United States, 03301
Contact: Frederick Briccetti, M.D.    603-552-9170      
Wentworth Douglass Hospital Recruiting
Dover, New Hampshire, United States, 03820
Contact: Taylor Ortiz, M.D.    603-742-8787      
New Hampshire Oncology Hematology Associates Recruiting
Hooksett, New Hampshire, United States, 03106
Contact: Frederick Briccetti, M.D.    603-552-9170      
LRGHealthcare-Lakes Region General Hospital Recruiting
Laconia, New Hampshire, United States, 03246
Contact: Frederick Briccetti, M.D.    603-552-9170      
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Richard Lauer, M.D.    505-925-0478      
Memorial Medical Center-Las Cruces Recruiting
Las Cruces, New Mexico, United States, 88011
Contact: Richard Lauer, M.D.    505-925-0478      
Christus Saint Vincent Regional Cancer Center Recruiting
Santa Fe, New Mexico, United States, 87505
Contact: Richard Lauer, M.D.    505-925-0478      
United States, New York
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Contact: Kevin Becker, M.D.    718-765-2600      
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Michael J. Morris    212-639-2000      
United States, North Carolina
Randolph Hospital Recruiting
Asheboro, North Carolina, United States, 27203
Contact: James Granfortuna, M.D.    336-832-1100      
Core Health Cancer Center Recruiting
Greensboro, North Carolina, United States, 27403
Contact: James Granfortuna, M.D.    336-832-1100      
Annie Penn Memorial Hospital Recruiting
Reidsville, North Carolina, United States, 27320
Contact: James Granfortuna, M.D.    336-832-1100      
Marion L. Shepard Cancer Center at Beaufort County Hospital Recruiting
Washington, North Carolina, United States, 27889
Contact: John J. Inzerillo    252-975-4308      
United States, North Dakota
Sanford Bismarck Medical Center Recruiting
Bismarck, North Dakota, United States, 58501
Contact: Preston Steen, M.D.    701-234-6161      
Sanford Clinic North-Fargo Recruiting
Fargo, North Dakota, United States, 58102
Contact: Preston Steen, M.D.    701-234-6161      
Sanford Medical Center-Fargo Recruiting
Fargo, North Dakota, United States, 58122
Contact: Preston Steen, M.D.    701-234-6161      
United States, Ohio
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Matthew Cooney, M.D.    216-844-7048      
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Anjali Advani, M.D.    216-445-9354      
United States, Oklahoma
Cancer Centers of Southwest Oklahoma, LLC - Lawton Recruiting
Lawton, Oklahoma, United States, 73505
Contact: Nadim F. Nimeh, MD    580-536-2121 ext 113      
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Sindhu Singh, M.D.    405-271-8777      
United States, Oregon
Good Samaritan Hospital Recruiting
Corvallis, Oregon, United States, 97330
Contact: Kimberly McGregor, M.D.    541-768-4771      
Kaiser Permanente Health Care - Portland Recruiting
Portland, Oregon, United States, 97232
Contact: Nagendra Tirumali, MD    503-331-6500      
United States, Pennsylvania
Adams Cancer Center Recruiting
Gettysburg, Pennsylvania, United States, 17325
Contact: Amir Tabatabai    717-741-8124      
WellSpan Health-York Hospital Recruiting
York, Pennsylvania, United States, 17405
Contact: Amir Tabatabai, M.D.    717-741-9229      
United States, South Dakota
Sanford Cancer Center Oncology Clinic Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Miroslaw Mazurczak    605-328-8000      
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Craig Swainey, M.D.    804-828-9723      
United States, Washington
PeaceHealth Saint Joseph Medical Center Recruiting
Bellingham, Washington, United States, 98225
Contact: Gary Goodman, M.D.    206-386-2122      
Harrison Health Partners Hematology and Oncology - Poulsbo Recruiting
Poulsbo, Washington, United States, 98370
Contact: Gary Goodman, M.D.    206-386-2122      
United States, West Virginia
Saint Mary's Medical Center Recruiting
Huntington, West Virginia, United States, 25702
Contact: Arvinder Bir, M.D.    304-528-4658      
United States, Wisconsin
Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301
Contact: Anthony Jaslowski, M.D.    920-884-3135      
Green Bay Oncology at Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301-3526
Contact: Anthony J. Jaslowski    610-402-2273      
Saint Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Anthony J. Jaslowski    610-402-2273      
Holy Family Memorial Hospital Recruiting
Manitowoc, Wisconsin, United States, 54221
Contact: Anthony J. Jaslowski    610-402-2273      
Saint Joseph's Hospital Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Seth O. Fagbemi, MD    715-387-5426      
Marshfield Clinic Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Seth Fagbemi, M.D.    715-387-5426      
Green Bay Oncology - Oconto Falls Recruiting
Oconto Falls, Wisconsin, United States, 54154
Contact: Anthony J. Jaslowski    610-402-2273      
Saint Nicholas Hospital Recruiting
Sheboygan, Wisconsin, United States, 53081
Contact: Anthony Jaslowski, M.D.    920-884-3135      
Marshfield Clinic at Saint Michael's Hospital Recruiting
Stevens Point, Wisconsin, United States, 54481
Contact: Seth O. Fagbemi, MD    715-387-5426      
Saint Michael's Hospital Cancer Center Recruiting
Stevens Point, Wisconsin, United States, 54481
Contact: Seth O. Fagbemi, MD    715-387-5426      
Green Bay Oncology - Sturgeon Bay Recruiting
Sturgeon Bay, Wisconsin, United States, 54235
Contact: Anthony J. Jaslowski    610-402-2273      
Marshfield Clinic - Weston Center Recruiting
Weston, Wisconsin, United States, 54476
Contact: Seth Fagbemi, M.D.    715-387-5426      
Diagnostic and Treatment Center Recruiting
Weston, Wisconsin, United States, 54476
Contact: Seth Fagbemi, M.D.    715-387-5426      
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Astellas Pharma US, Inc.
Medivation, Inc.
Biologics, Inc.
Investigators
Study Chair: Michael Morris, M.D. Memorial Sloan-Kettering Cancer Center
  More Information

No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01949337     History of Changes
Other Study ID Numbers: A031201, U10CA031946, NCI-2013-01737
Study First Received: September 20, 2013
Last Updated: May 14, 2014
Health Authority: United States: Food and Drug Administration
United States: NCI Central Institutional Review Board

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Prostatic Diseases
Urogenital Neoplasms
Prednisone
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014