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SWOG-S1014: Abiraterone Acetate Treatment for Prostate Cancer Patients with a PSA of More Than Four Following Initial Androgen Deprivation Therapy, Phase II.

Description

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.

Phase

Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.

Inclusion and Exclusion Criteria

  • Histologically or cytologically proven diagnosis of adenocarcinoma of the prostate
  • Metastatic (M1) disease as evidenced by soft tissue and/or bony metastases at the time of initiation of androgen-deprivation therapy (ADT)
  • Must have at least one of the following:
  • Visceral disease (liver, lung, other viscera)
  • Bone metastases to sites in either the axial (spine, pelvis, ribs, or skull) and/or the appendicular (clavicle, humerus, or femur) skeleton
  • Distant lymph node disease (e.g., above the aortic bifurcation, etc.)
  • No small cell or neuroendocrine prostate cancer
  • Patients must be receiving ADT (e.g., gonadotropin-releasing hormone [GNRH] antagonist, with or without antiandrogen) prior to entering this study
  • Degarelix, a FDA-approved GNRH antagonist, is an acceptable form of ADT
  • Bilateral surgical orchiectomy is also acceptable
  • Suboptimal response to ADT induction as defined by the following criteria:
  • Declining PSA (current PSA is less than the PSA prior to starting ADT) that fails to reach 4 ng/mL or below despite continuous ADT
  • PSA of > 4 ng/mL must be observed between 6-12 months after the initiation of ADT
  • Documentation of failure to achieve this PSA of ≤ 4 ng/mL must be within 28 days of registration
  • The PSA must be obtained after any applicable antiandrogen washout period
  • If the PSA is declining or stable (defined as a PSA rise ≤ 0.1 ng/mL from nadir) and the patient is on an antiandrogen, they must remain on the antiandrogen
  • Patients with stable or declining PSA who have had previous antiandrogen exposure, but are not taking an antiandrogen at the time of registration, must wait at least 6 weeks from the last antiandrogen dose before registration and still demonstrate a stable or falling PSA which is > 4 ng/mL by month 12, in order to be eligible
  • 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/

Sites

  • California

    • Kaiser Permanente Fresno Medical Center, Fresno, California, 93720
    • Kaiser Permanente Medical Center - Santa Teresa, San Jose, California, 95119
    • Kaiser Permanente Medical Center - Santa Clara Kiely Campus, Santa Clara, California, 95051
    • Kaiser Permanente - Fremont, Fremont, California, 94538
    • Kaiser Permanente Medical Facility - Stockton, Stockton, California, 95210
    • Kaiser Permanente Medical Center - Redwood City, Redwood City, California, 94063
    • Kaiser Permanente Medical Center - Hayward, Hayward, California, 94545
    • Kaiser Permanente - Deer Valley, Antioch, California, 94531
    • Kaiser Permanente Medical Center - Walnut Creek, Walnut Creek, California, 94596
    • Kaiser Permanente Medical Center - South San Francisco, South San Francisco, California, 94080
    • Kaiser Permanente Medical Center - Oakland, Oakland, California, 94611
    • Kaiser Permanente Medical Center - San Francisco Geary Campus, San Francisco, California, 94115
    • South Sacramento Kaiser-Permanente Medical Center, Sacramento, California, 95823
    • Kaiser Permanente Medical Center - Richmond, Richmond, California, 94801
    • Kaiser Permanente Medical Center - Sacramento, Sacramento, California, 95825
    • Kaiser Permanente Medical Center - Vallejo, Vallejo, California, 94589
    • Kaiser Permanente Medical Center - Roseville, Roseville, California, 95661
    • Kaiser Foundation Hospital - San Rafael, San Rafael, California, 94903
    • Kaiser Permanente Medical Center - Vacaville, Vacaville, California, 95688
    • Tahoe Forest Cancer Center, Truckee, California, 96161
    • Kaiser Permanente Medical Center - Santa Rosa, Santa Rosa, California, 95403
    • Tibotec Therapeutics - Division of Ortho Biotech Products, LP, Marysville, California, 95901
  • Nevada

    • University Medical Center of Southern Nevada, Las Vegas, Nevada, 89102
    • CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada, 89106
  • Utah

    • Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, 84112
  • Idaho

    • Mountain States Tumor Institute at St. Luke's, Twin Falls, Idaho, 83301
    • Saint Luke's Mountain States Tumor Institute, Nampa, Idaho, 83686
    • Mountain States Tumor Institute - Meridian, Meridian, Idaho, 83642
    • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center, Boise, Idaho, 83706
    • Mountain States Tumor Institute at St. Luke's Regional Medical Center, Boise, Idaho, 83712
    • Saint Luke's Mountain States Tumor Institute - Fruitland, Fruitland, Idaho, 83619
    • St. Joseph Regional Medical Center, Lewiston, Idaho, 83501
  • Colorado

    • Montrose Memorial Hospital Cancer Center, Montrose, Colorado, 81401
    • Valley View Hospital Cancer Center, Glenwood Springs, Colorado, 81601
    • San Luis Valley Regional Medical Center, Alamosa, Colorado, 81101
    • Shaw Regional Cancer Center, Edwards, Colorado, 81632
    • Memorial Hospital Cancer Center - Colorado Springs, Colorado Springs, Colorado, 80909
    • Front Range Cancer Specialists, Fort Collins, Colorado, 80528
    • Poudre Valley Hospital, Fort Collins, Colorado, 80524
  • New Mexico

    • Hematology Oncology Associates, PC, Albuquerque, New Mexico, 87106
    • New Mexico Cancer Care Associates, Santa Fe, New Mexico, 87505
  • Wyoming

    • Rocky Mountain Oncology, Casper, Wyoming, 82609
  • Washington

    • Good Samaritan Cancer Center, Puyallup, Washington, 98372
    • St. Clare Hospital, Tacoma, Washington, 98499
    • CCOP - Northwest, Tacoma, Washington, 98405
    • Allenmore Hospital, Tacoma, Washington, 98405
    • MultiCare Regional Cancer Center at Tacoma General Hospital, Tacoma, Washington, 98405
    • St. Francis Hospital, Federal Way, Washington, 98003
    • Providence Regional Cancer Partnership, Everett, Washington, 98201
  • Kansas

    • Cancer Center of Kansas, PA - Liberal, Liberal, Kansas, 67901
    • Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas, 67801
    • Hays Medical Center, Hays, Kansas, 67601
    • Cancer Center of Kansas, PA - Pratt, Pratt, Kansas, 67124
    • St. Rose Ambulatory and Surgery Center, Great Bend, Kansas, 67530
    • Cancer Center of Kansas, PA - Kingman, Kingman, Kansas, 67068
    • Hutchinson Hospital Corporation, Hutchinson, Kansas, 67502
    • Cancer Center of Kansas, PA - Wellington, Wellington, Kansas, 67152
    • Cancer Center of Kansas, PA - Salina, Salina, Kansas, 67401
    • Tammy Walker Cancer Center at Salina Regional Health Center, Salina, Kansas, 67401
    • Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, 67214
    • CCOP - Wichita, Wichita, Kansas, 67214
    • Cancer Center of Kansas, PA - Wichita, Wichita, Kansas, 67214
    • Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas, 67208
    • Associates in Womens Health, PA - North Review, Wichita, Kansas, 67208
    • Cancer Center of Kansas, PA - Newton, Newton, Kansas, 67114
    • Cancer Center of Kansas, PA - Winfield, Winfield, Kansas, 67156
    • Cancer Center of Kansas-Independence, Independence, Kansas, 67301
    • St. Francis Comprehensive Cancer Center, Topeka, Kansas, 66606
    • Cotton-O'Neil Cancer Center, Topeka, Kansas, 66606
    • Cancer Center of Kansas, PA - Chanute, Chanute, Kansas, 66720
    • Cancer Center of Kansas, PA - Parsons, Parsons, Kansas, 67357
    • Lawrence Memorial Hospital, Lawrence, Kansas, 66044
    • Mount Carmel Regional Cancer Center, Pittsburg, Kansas, 66762
    • Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, 66701
    • Kansas City Cancer Centers - West, Kansas City, Kansas, 66112
    • Kansas City Cancer Centers - Southwest, Overland Park, Kansas, 66210
    • Kansas City Cancer Center - Shawnee Mission, Shawnee Mission, Kansas, 66204
  • Texas

    • CCOP - Scott and White Hospital, Temple, Texas, 76508
  • Missouri

    • Kansas City Cancer Centers - North, Kansas City, Missouri, 64154
    • Kansas City Cancer Centers - South, Kansas City, Missouri, 64131
    • Truman Medical Center - Hospital Hill, Kansas City, Missouri, 64108
    • Kansas City Cancer Centers - East, Lee's Summit, Missouri, 64064
    • CCOP - Cancer Research for the Ozarks, Springfield, Missouri, 65802
    • Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri, 65807
    • St. John's Regional Health Center, Springfield, Missouri, 65804
    • David C. Pratt Cancer Center at St. John's Mercy, Saint Louis, Missouri, 63141
    • CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, 63141
    • Midwest Hematology Oncology Group, Incorporated, Saint Louis, Missouri, 63109
    • Saint Francis Medical Center, Cape Girardeau, Missouri, 63703
  • Arkansas

    • Highlands Oncology Group - Springdale, Rogers, Arkansas, 72758
    • NEA Medical Clinic - East Matthews, Jonesboro, Arkansas, 72401
  • Louisiana

    • Highland Clinic, Shreveport, Louisiana, 71105
    • Cancer Center of Acadiana at Lafayette General Medical Center, Lafayette, Louisiana, 70503
  • Iowa

    • Genesis Regional Cancer Center at Genesis Medical Center, Davenport, Iowa, 52803
  • Illinois

    • Good Samaritan Regional Health Center, Mount Vernon, Illinois, 62864
    • Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois, 62526
    • Mid-Illinois Hematology-Oncology Associates at Community Cancer Center, Normal, Illinois, 61761
  • Michigan

    • Mercy General Health Partners, Muskegon, Michigan, 49444
    • CCOP - Grand Rapids, Grand Rapids, Michigan, 49503
    • Butterworth Hospital at Spectrum Health, Grand Rapids, Michigan, 49503
    • Lacks Cancer Center at Saint Mary's Health Care, Grand Rapids, Michigan, 49503
    • Mecosta County Medical Center, Big Rapids, Michigan, 49307
    • Battle Creek Health System Cancer Care Center, Battle Creek, Michigan, 49017
    • Spectrum Health Reed City Hospital, Reed City, Michigan, 49677
    • Munson Medical Center, Traverse City, Michigan, 49684
    • Foote Memorial Hospital, Jackson, Michigan, 49201
    • Northern Michigan Hospital, Petoskey, Michigan, 49770
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