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Abiraterone Acetate Treatment for Prostate Cancer Patients With a PSA of More Than Four Following Initial Androgen Deprivation Therapy Phase II


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

Abiraterone Acetate Treatment for Prostate Cancer Patients With a PSA of More Than Four Following Initial Androgen Deprivation Therapy Phase II


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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/μL

- Platelet count ≥ 100,000/μL

- Hemoglobin ≥ 10 g/dL

- Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) OR creatinine clearance
≥ 60 mL/min

- Bilirubin ≤ 1.5 times ULN (unless documented Gilbert disease)

- AST and ALT < 1.5 times ULN

- Potassium ≥ 3.5 mmol/L

- Patient must have a testosterone value of < 50 ng/dL obtained within 28 days prior to
registration

- Patients must have controlled blood pressure defined as systolic blood pressure < 160
mm Hg and diastolic blood pressure < 95 mm Hg

- Patients with a history of hypertension are eligible provided blood pressure is
controlled by anti-hypertensive treatment

- Patients who have partners of child-bearing potential must be willing to use a method
of birth control with adequate barrier protection during the study and for 1 week
after the last study drug administration

- Must be able to take oral medication without crushing, dissolving, or chewing tablets

- Patients must not have a history of gastrointestinal disorders (medical disorders or
extensive surgery) that may interfere with the absorption of abiraterone acetate

- No other prior malignancy is allowed except for any of the following:

- Adequately treated basal cell or squamous cell skin cancer

- Adequately treated stage I or II cancer from which the patient is currently in
complete remission

- Any other cancer from which the patient has been disease-free for 5 years

- No patients with active or symptomatic viral hepatitis or chronic liver disease

- No moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment

- No history of NYHA class III or IV heart failure

- Patients must have LVEF ≥ 50%

- No known allergies, hypersensitivity, or intolerance to abiraterone acetate,
prednisone, or their excipients

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Patients with a history of prior neoadjuvant or adjuvant GNRH agonist/antagonist
therapy (related to previous surgery or radiation) are eligible provided they
finished this therapy at least two years prior to registration

- Prior enrollment to SWOG-S0925 (either arm) is not exclusionary

- At least 6 weeks since prior and no concurrent finasteride or dutasteride

- At least 28 days since prior radiotherapy or surgery and recovered

- At least 4 weeks since prior investigational products

- At least 4 weeks since prior flutamide (6 weeks for bicalutamide and nilutamide) with
no evidence of a falling PSA

- No other concurrent oral antiandrogen

- No prior or concurrent cytotoxic chemotherapy or radiopharmaceuticals for prostate
cancer

- No prior or concurrent ketoconazole for the treatment of prostate cancer

- Not requiring more than 10 mg a day of prednisone for another medical indication

- Not planning to receive any concurrent cytotoxic chemotherapy, immunotherapy,
surgery, or radiotherapy during protocol treatment

- No concurrent hormonal-acting agents, including diethylstilbestrol/DES, aldosterone,
PC-SPES, or spironolactone

- No concurrent antifungal medication (e.g., fluconazole or itraconazole)

- No medications that alter cardiac conduction

- No prior Provenge (sipuleucel-T)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rates of undetectable PSA

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Thomas W. Flaig, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000696565

NCT ID:

NCT01309672

Start Date:

September 2011

Completion Date:

June 2015

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • hormone-resistant prostate cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical CenterGrand Junction, Colorado  81502
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
CCOP - Scott and White HospitalTemple, Texas  76508
MultiCare Regional Cancer Center at Tacoma General HospitalTacoma, Washington  98405
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - HoustonHouston, Texas  77030
CCOP - NorthwestTacoma, Washington  98405-0986
Kaiser Permanente Medical Center - VallejoVallejo, California  94589
University of California Davis Cancer CenterSacramento, California  95817
Kaiser Permanente Medical Center - San Francisco Geary CampusSan Francisco, California  94115
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Thompson Cancer Survival CenterKnoxville, Tennessee  37916
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Winthrop University HospitalMineola, New York  11501
Central Baptist HospitalLexington, Kentucky  40503
Kaiser Permanente Medical Center - OaklandSacramento, California  95825
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Baylor University Medical Center - HoustonHouston, Texas  77030-2399
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Good Samaritan Regional Health CenterMt. Vernon, Illinois  62864
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Northern Michigan HospitalPetoskey, Michigan  49770
Munson Medical CenterTraverse City, Michigan  49684
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
Kaiser Permanente Medical Center - Santa Clara Kiely CampusSanta Clara, California  95051-5386
M.D. Anderson Cancer Center at OrlandoOrlando, Florida  32806
Mountain States Tumor Institute at St. Luke's Regional Medical CenterBoise, Idaho  83712-6297
Tulane Cancer Center Office of Clinical ResearchAlexandria, Louisiana  71315-3198
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
St. Luke's - Roosevelt Hospital Center - St.Luke's DivisionNew York, New York  10027
Kaiser Permanente Medical Center - SacramentoSacramento, California  95825
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Front Range Cancer SpecialistsFort Collins, Colorado  80528
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Kaiser Permanente - FremontFremont, California  94538
Kaiser Permanente Medical Center - HaywardHayward, California  94545
Kaiser Permanente Medical Center - Redwood CityRedwood City, California  94063
Kaiser Permanente Medical Center - RichmondRichmond, California  94801
Kaiser Permanente Medical Center - RosevilleRoseville, California  95661
South Sacramento Kaiser-Permanente Medical CenterSacramento, California  95823
Kaiser Permanente Medical Center - Santa TeresaSan Jose, California  95119
Kaiser Foundation Hospital - San RafaelSan Rafael, California  94903
Kaiser Permanente Medical Center - Santa RosaSanta Rosa, California  95403
Kaiser Permanente Medical Center - South San FranciscoSouth San Francisco, California  94080
Kaiser Permanente Medical Facility - StocktonStockton, California  95210
Kaiser Permanente Medical Center - Walnut CreekWalnut Creek, California  94596
Poudre Valley HospitalFort Collins, Colorado  80524
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
Genesis Regional Cancer Center at Genesis Medical CenterDavenport, Iowa  52803
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
St. Francis Comprehensive Cancer CenterTopeka, Kansas  66606
Feist-Weiller Cancer Center at Louisiana State University Health SciencesShreveport, Louisiana  71130-3932
Bay Regional Medical CenterBay City, Michigan  48708
Mecosta County Medical CenterBig Rapids, Michigan  49307
Saint Francis Medical CenterCape Girardeau, Missouri  63701
Iredell Memorial HospitalStatesville, North Carolina  28677
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical CenterKingsport, Tennessee  37662
UMC Southwest Cancer and Research CenterLubbock, Texas  79415-3364
Montrose Memorial Hospital Cancer CenterMontrose, Colorado  81401
St. Francis HospitalFederal Way, Washington  98003
St. Clare HospitalLakewood, Washington  98499-0998
Providence St. Peter Hospital Regional Cancer CenterOlympia, Washington  98506
Good Samaritan Cancer CenterPuyallup, Washington  98371
Allenmore HospitalTacoma, Washington  98411-0414
Kaiser Permanente - Deer ValleyAntioch, California  94531
Kaiser Permanente - Moanalua Medical Center and ClinicHonolulu, Hawaii  96819
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - LiberalLiberal, Kansas  67905
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cotton-O'Neil Cancer CenterTopeka, Kansas  66606
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Truman Medical Center - Hospital HillKansas City, Missouri  64108
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Grant Medical Center Cancer CareColumbus, Ohio  43215
Knox Community HospitalMount Vernon, Ohio  43050
Mount Carmel St. Ann's Cancer CenterWesterville, Ohio  43081
Providence Centralia HospitalCentralia, Washington  98531-9027
Franciscan Cancer Center at St. Joseph Medical CenterTacoma, Washington  98405-3004
Rocky Mountain OncologyCasper, Wyoming  82609
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Ben Taub General HospitalHouston, Texas  77030
Queen's Cancer Institute at Queen's Medical CenterHonolulu, Hawaii  96813
Tucker Center for Cancer Care at Orange Regional Medical CenterMiddletown, New York  10940-4199
New Mexico Cancer Care AssociatesSanta Fe, New Mexico  87505-7670
McLeod Regional Medical CenterFlorence, South Carolina  29501
Highlands Oncology Group - SpringdaleSpringdale, Arkansas  72764
Mid-Illinois Hematology-Oncology Associates at Community Cancer CenterNormal, Illinois  61761
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Midwest Hematology Oncology Group, IncorporatedSaint Louis, Missouri  63109
Tibotec Therapeutics - Division of Ortho Biotech Products, LPMarysville, California  95901
Tahoe Forest Cancer CenterTruckee, California  96161
Kapiolani Medical Center at Pali MomiAiea, Hawaii  96701
Kapiolani Medical Center for Women and ChildrenHonolulu, Hawaii  96826
Straub Clinic and Hospital, IncorporatedHonolulu, Hawaii  96813
OnCare Hawaii, Incorporated - KuakiniHonolulu, Hawaii  96817
OnCare Hawaii, Incorporated - LusitanaHonolulu, Hawaii  96813
Mercy General Health PartnersMuskegon, Michigan  49443
Valley Hospital - RidgewoodRidgewood, New Jersey  07450
Hematology-Oncology ClinicBaton Rouge, Louisiana  70808
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Hematology Oncology Associates, PCAlbuquerque, New Mexico  87106
Memorial Hospital Cancer Center - Colorado SpringsColorado Springs, Colorado  80909
St. Luke's Texas Cancer Institute at St. Luke's Episcopal HospitalHouston, Texas  77030
Mount Carmel Regional Cancer CenterPittsburg, Kansas  66762
Caritas Holy Family HospitalMethuen, Massachusetts  01844
Falck Cancer Center at Arnot Ogden Medical CenterElmira, New York  14905
Shaw Regional Cancer CenterEdwards, Colorado  81632
Kansas City Cancer Centers - SouthwestOverland Park, Kansas  66210
San Luis Valley Regional Medical CenterAlamosa, Colorado  81101
Valley View Hospital Cancer CenterGlenwood Springs, Colorado  81601
Castle Medical CenterKailua, Hawaii  96734
Kauai Medical ClinicLihue, Hawaii  96766
Hays Medical CenterHays, Kansas  67601
Hutchinson Hospital CorporationHutchinson, Kansas  67502
Clemens Regional Medical CenterMount Clemens, Michigan  48043
Saint Luke's Mountain States Tumor InstituteBoise, Idaho  83712
Highland ClinicShreveport, Louisiana  71105
Southern Ohio Medical Center Cancer CenterPortsmouth, Ohio  45662
McLaren Cancer InstituteFlint, Michigan  48532
Kansas City Cancer Centers - NorthKansas City, Missouri  64154
Kansas City Cancer Centers - SouthKansas City, Missouri  64131
Kuakini Medical CenterHonolulu, Hawaii  96817
Saint Luke's Mountain States Tumor Institute - FruitlandFruitland, Idaho  83619
Mountain States Tumor Institute - MeridianMeridian, Idaho  83642
Mountain States Tumor Institute at St. Luke'sTwin Falls, Idaho  83301
St. Rose Ambulatory and Surgery CenterGreat Bend, Kansas  67530
Kansas City Cancer Centers - WestKansas City, Kansas  66112
Kansas City Cancer Center - Shawnee MissionShawnee Mission, Kansas  66204
Kansas City Cancer Centers - EastLee's Summit, Missouri  64064
Spectrum Health Reed City HospitalReed City, Michigan  49677
Providence Regional Cancer PartnershipEverett, Washington  98201
Kaiser Permanente Medical Center - VacavilleVacaville, California  95688
St. Joseph Regional Medical CenterLewiston, Idaho  83501
Oncare Hawaii, Incorporated - Pali MomiAiea, Hawaii  96701
Kaiser Permanente Fresno Medical CenterFresno, California  93720
Singh and Arora Hematology Oncology, PCFlint, Michigan  48532
Great Lakes Cancer Institute - Lapeer CampusLapeer, Michigan  48446
NEA Medical Clinic - East MatthewsJonesboro, Arkansas  72401
Cancer Center of Acadiana at Lafayette General Medical CenterLafayette, Louisiana  70503