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Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients With High-Risk, Clinically Localized Prostate Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients With High-Risk, Clinically Localized Prostate Cancer


OBJECTIVES:

Primary

- Compare the rate of 3-year biochemical progression-free survival (bPFS) in patients
with high-risk, clinically localized prostate cancer treated with radical prostatectomy
with vs without neoadjuvant chemohormonal therapy comprising docetaxel and
androgen-deprivation therapy with leuprolide acetate or goserelin.

Secondary

- Compare the 5-year bPFS rate, bPFS, disease progression, disease-free survival, and
overall survival of patients treated with these regimens.

- Determine the safety and tolerability of neoadjuvant docetaxel and androgen-deprivation
therapy in these patients.

- Compare the time to clinically apparent local disease recurrence and metastatic disease
in patients treated with these regimens.

- Compare pathologic tumor stage, frequency of lymph node metastases, and positive margin
rates in patients treated with these regimens.

- Determine if changes in serum testosterone levels will predict bPFS in these patients.

- Determine, prospectively, whether prostate-specific antigen doubling time is a
surrogate endpoint for time to clinical metastases and overall survival in these
patients.

OUTLINE: This is a multicenter, randomized study. Patients are stratified according to
nomogram-predicted biochemical progression-free survival at 5 years (0-20.9% vs 21-39.9% vs
40-59.9% vs ≥ 60%) and androgen-deprivation therapy in the past 3 months (no vs yes).
Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive goserelin subcutaneously or leuprolide acetate intramuscularly
once every 4 or 12 weeks for 18-24 weeks (measured from the date of starting
docetaxel). They also receive docetaxel IV over 1 hour on day 1. Treatment with
docetaxel repeats every 3 weeks for up to 6 courses. Within 60 days after completion of
chemohormonal therapy, patients undergo radical prostatectomy with staging pelvic
lymphadenectomy.

- Arm II: Within 60 days after randomization, patients undergo radical prostatectomy with
staging pelvic lymphadenectomy.

After completion of study therapy, patients are followed at 1 and 3 months and then
periodically for up to 15 years.

PROJECTED ACCRUAL: A total of 750 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate

- No small cell, neuroendocrine, or transitional cell carcinoma

- Clinically localized, stage T1-3a disease

- No radiographic evidence of metastatic disease*, as demonstrated by all of the
following:

- No pelvic lymph nodes > 1.5 cm by CT scan or MRI of the abdomen and pelvis or
endorectal MRI of the pelvis

- A negative biopsy required for lymph node(s) that measure > 1.5 cm

- If > 1 lymph node is > 1.5 cm, the largest or most accessible node is
biopsied

- Negative bone scan with plain films and/or MRI/CT scan confirmation, if
necessary NOTE: *Positive positron emission tomography scan and Prostascint
scans are not considered proof of metastatic disease

- Serum prostate-specific antigen level ≤ 100 ng/mL within the past 6 weeks

- Patients must have a known Gleason sum based on biopsy or TURP at study entry

- High-risk disease, meeting 1 of the following criteria:

- Probability of biochemical progression-free survival at 5 years after surgery <
60% by Kattan nomogram prediction

- Biopsy Gleason score 8 to 10

- Deemed an appropriate candidate for radical prostatectomy

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy > 10 years

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 150,000/mm^3

- Creatinine ≤ 2.0 mg/dL

- Bilirubin normal (≤ 2.5 times upper limit of normal [ULN] for patients with Gilbert's
disease)

- AST and ALT ≤ 1.5 times ULN

- Fertile patients must use effective contraception during and for ≥ 2 months after
completion of study treatment

- Not at high risk for cardiac complications

- Prior deep venous thrombosis, pulmonary embolism, and/or cerebrovascular
accident allowed

PRIOR CONCURRENT THERAPY:

- No prior treatment for prostate cancer, including surgery, pelvic lymph node
dissection, radiotherapy, or chemotherapy

- Prior transurethral resection of prostate allowed

- Prior androgen-deprivation therapy (e.g., luteinizing hormone-releasing hormone
agonists, antiandrogens, or both) lasting ≤ 4 months allowed

- Concurrent systemic anticoagulation allowed

- No other concurrent systemic therapy, including androgen-deprivation therapy for the
treatment of the prostate cancer

- No concurrent oral antiandrogens

- No concurrent aprepitant

- No other concurrent chemotherapeutic agents except for any of the following:

- Steroids given for adrenal failure

- Hormones administered for nondisease-related conditions (e.g., insulin for
diabetes)

- Intermittent use of dexamethasone as an antiemetic or as pretreatment for
patients receiving docetaxel

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

3-year biochemical progression-free survival (bPFS) rate

Safety Issue:

No

Principal Investigator

James A. Eastham, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

Unspecified

Study ID:

CDR0000526353

NCT ID:

NCT00430183

Start Date:

December 2006

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • adenocarcinoma of the prostate
  • Prostatic Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
University of Chicago Cancer Research CenterChicago, Illinois  60637
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Hurley Medical CenterFlint, Michigan  48503
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
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
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
St. Rita's Medical CenterLima, Ohio  45801
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - GreenvilleGreenville, South Carolina  29615
Virginia Mason Medical CenterSeattle, Washington  98111
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
MultiCare Regional Cancer Center at Tacoma General HospitalTacoma, Washington  98405
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
CCOP - NorthwestTacoma, Washington  98405-0986
Naval Medical Center - San DiegoSan Diego, California  92134-3202
Peninsula Regional Medical CenterSalisbury, Maryland  21801
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
University of California Davis Cancer CenterSacramento, California  95817
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
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
Maine Center for Cancer Medicine and Blood Disorders - ScarboroughScarborough, Maine  04074
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Overlook HospitalSummit, New Jersey  07902-0220
Carol G. Simon Cancer Center at Morristown Memorial HospitalMorristown, New Jersey  07962
Mercy Fitzgerald HospitalDarby, Pennsylvania  19023
Yale Cancer CenterNew Haven, Connecticut  06520-8028
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Edwards Comprehensive Cancer Center at Cabell Huntington HospitalHuntington, West Virginia  25701
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa  52722
Somerset Medical CenterSomerville, New Jersey  08876
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Munson Medical CenterTraverse City, Michigan  49684
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, 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
Veterans Affairs Medical Center - HinesHines, Illinois  60141
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Madigan Army Medical Center - TacomaTacoma, Washington  98431
West Virginia University Health Sciences Center - CharlestonCharleston, West Virginia  25302
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Helen and Harry Gray Cancer Center at Hartford HospitalHartford, Connecticut  06102-5037
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Peninsula Medical CenterBurlingame, California  94010
Sutter Health - Western Division Cancer Research GroupGreenbrae, California  94904
California Pacific Medical Center - California CampusSan Francisco, California  94118
Sutter Solano Medical CenterVallejo, California  94589
Ella Milbank Foshay Cancer Center at Jupiter Medical CenterJupiter, Florida  33458
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Genesis Regional Cancer Center at Genesis Medical CenterDavenport, Iowa  52803
St. Francis Comprehensive Cancer CenterTopeka, Kansas  66606
Pennington Cancer Center at Baton Rouge GeneralBaton Rouge, Louisiana  70806
Mary Bird Perkins Cancer Center - Baton RougeBaton Rouge, Louisiana  70809
Medical Center of Louisiana - New OrleansNew Orleans, Louisiana  70112
Mecosta County Medical CenterBig Rapids, Michigan  49307
Coborn Cancer CenterSaint Cloud, Minnesota  56303
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Immanuel Medical CenterOmaha, Nebraska  68122
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Iredell Memorial HospitalStatesville, North Carolina  28677
Forsyth Regional Cancer Center at Forsyth Medical CenterWinston-Salem, North Carolina  27103
Kaiser Permanente Health Care - PortlandPortland, Oregon  97232
Bon Secours St. Francis Health SystemGreenville, South Carolina  29601
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical CenterKingsport, Tennessee  37662
Mountainview MedicalBerlin, Vermont  05602
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Fairbanks Cancer Treatment Center at Fairbanks Memorial HospitalFairbanks, Alaska  99701
Denver Health Medical CenterDenver, Colorado  80204-4507
Montrose Memorial Hospital Cancer CenterMontrose, Colorado  81401
St. Francis HospitalFederal Way, Washington  98003
Cascade Cancer Center at Evergreen Hospital Medical CenterKirkland, Washington  98034-3013
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
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612
Cancer Resource Center - LincolnLincoln, Nebraska  68510
Alta Bates Summit Comprehensive Cancer CenterBerkeley, California  94704
Eastern Connecticut Hematology and Oncology AssociatesNorwich, Connecticut  06360
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida  33308
Michiana Hematology-Oncology, PC - ElkhartElkhart, Indiana  46514
Elkhart Clinic, LLCElkhart, Indiana  46514-2098
Michiana Hematology Oncology PC - La PorteLa Porte, Indiana  46350
Michiana Hematology-Oncology, PC - South BendMishawaka, Indiana  46545-1470
Michiana Hematology Oncology PC - PlymouthPlymouth, Indiana  46563
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
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
Lakeside Cancer Specialists, PLLCSaint Joseph, Michigan  49085
Willmar Cancer Center at Rice Memorial HospitalWillmar, Minnesota  56201
Truman Medical Center - Hospital HillKansas City, Missouri  64108
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Alegant Health Cancer Center at Bergan Mercy Medical CenterOmaha, Nebraska  68124
Frederick R. and Betty M. Smith Cancer Treatment CenterSparta, New Jersey  07871
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Southwest Virginia Regional Cancer Center at Wellmonth HealthNorton, Virginia  24273
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
Queen's Cancer Institute at Queen's Medical CenterHonolulu, Hawaii  96813
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Duke Cancer InstituteDurham, North Carolina  27710
Kinston Medical SpecialistsKinston, North Carolina  28501
MBCCOP - Meharry Medical College - NashvilleNashville, Tennessee  37208-3599
Providence Cancer CenterAnchorage, Alaska  99508
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Roper St. Francis Cancer Center at Roper HospitalCharleston, South Carolina  29401
Rockwood Clinic Cancer Treatment CenterSpokane, Washington  99204-2967
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Berkshire Hematology Oncology, PCPittsfield, Massachusetts  01201
Lynchburg Hematology-Oncology ClinicLynchburg, Virginia  24501
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
Hawaii Medical Center - EastHonolulu, Hawaii  96817
OnCare Hawaii, Incorporated - KuakiniHonolulu, Hawaii  96817
OnCare Hawaii, Incorporated - LusitanaHonolulu, Hawaii  96813
Maui Memorial Medical CenterWailuku, Hawaii  96793
Pacific Cancer Institute - MauiWailuku, Hawaii  96793
Mercy General Health PartnersMuskegon, Michigan  49443
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer CareConcord, New Hampshire  03301
New Hampshire Oncology - Hematology, PA - HooksettHooksett, New Hampshire  03106
Bay Area HospitalCoos Bay, Oregon  97420
AnMed Cancer CenterAnderson, South Carolina  29621
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Cleveland Clinic Florida - WestonWeston, Florida  33331
Veterans Affairs Medical Center - West HavenWest Haven, Connecticut  06516
Hematology Oncology Associates, PCAlbuquerque, New Mexico  87106
Minnesota Oncology - MaplewoodMaplewood, Minnesota  55109
Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
Lakeview HospitalStillwater, Minnesota  55082
Minnesota Oncology - WoodburyWoodbury, Minnesota  55125
Mount Carmel Regional Cancer CenterPittsburg, Kansas  66762
Shaw Regional Cancer CenterEdwards, Colorado  81632
Tufts Medical Center Cancer CenterBoston, Massachusetts  02111
Kansas City Cancer Centers - SouthwestOverland Park, Kansas  66210
Valley View Hospital Cancer CenterGlenwood Springs, Colorado  81601
Castle Medical CenterKailua, Hawaii  96734
Kauai Medical ClinicLihue, Hawaii  96766
Central Dupage Cancer CenterWarrenville, Illinois  60555
Hays Medical CenterHays, Kansas  67601
Hutchinson Hospital CorporationHutchinson, Kansas  67502
Lakeside HospitalOmaha, Nebraska  68130
Presbyterian Cancer Treatment Center at Presbyterian Kaseman HospitalAlbuquerque, New Mexico  87110
New Ulm Medical CenterNew Ulm, Minnesota  56073
Pacific Medical CenterSeattle, Washington  98104
Kansas City Cancer Centers - NorthKansas City, Missouri  64154
Kansas City Cancer Centers - SouthKansas City, Missouri  64131
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
Idaho Urologic Institute, PAMeridian, Idaho  83642
Delnor Hospital - GenevaGeneva, Illinois  60134
Sutter Pacific Medical FoundationSanta Rosa, California  95403
Cleveland Regional Medical CenterShelby, North Carolina  28150
Benefis Sletten Cancer InstituteGreat Falls, Montana  59405
Carolinas Medical Center - UnionMonroe, North Carolina  28112
Seattle Cancer Care Alliance at EvergreenHealthKirkland, Washington  98034