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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 Institute Buffalo, New York  14263
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
University of Chicago Cancer Research Center Chicago, Illinois  60637
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Hurley Medical Center Flint, Michigan  48503
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
Hutchinson Area Health Care Hutchinson, Minnesota  55350
HealthEast Cancer Care at St. John's Hospital Maplewood, Minnesota  55109
Hennepin County Medical Center - Minneapolis Minneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical Center Shakopee, Minnesota  55379
Park Nicollet Cancer Center St. Louis Park, Minnesota  55416
Regions Hospital Cancer Care Center St. Paul, Minnesota  55101
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
St. Rita's Medical Center Lima, Ohio  45801
Memorial Hospital of South Bend South Bend, Indiana  46601
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Greenville Greenville, South Carolina  29615
Virginia Mason Medical Center Seattle, Washington  98111
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Saint Joseph Regional Medical Center South Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
CCOP - Grand Rapids Grand Rapids, Michigan  49503
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
MultiCare Regional Cancer Center at Tacoma General Hospital Tacoma, Washington  98405
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Veterans Affairs Medical Center - Denver Denver, Colorado  80220
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
Veterans Affairs Medical Center - Kansas City Kansas City, Missouri  64128
CCOP - Virginia Mason Research Center Seattle, Washington  98101
CCOP - Northwest Tacoma, Washington  98405-0986
Naval Medical Center - San Diego San Diego, California  92134-3202
Peninsula Regional Medical Center Salisbury, Maryland  21801
Veterans Affairs Medical Center - Syracuse Syracuse, New York  13210
University of California Davis Cancer Center Sacramento, California  95817
Louis A. Weiss Memorial Hospital Chicago, Illinois  60640
Fletcher Allen Health Care - University Health Center Campus Burlington, Vermont  05401
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City, Kansas  66160-7353
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
Maine Center for Cancer Medicine and Blood Disorders - Scarborough Scarborough, Maine  04074
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
Overlook Hospital Summit, New Jersey  07902-0220
Carol G. Simon Cancer Center at Morristown Memorial Hospital Morristown, New Jersey  07962
Mercy Fitzgerald Hospital Darby, Pennsylvania  19023
Yale Cancer Center New Haven, Connecticut  06520-8028
Florida Hospital Cancer Institute at Florida Hospital Orlando Orlando, Florida  32803-1273
SUNY Upstate Medical University Hospital Syracuse, New York  13210
Presbyterian Cancer Center at Presbyterian Hospital Charlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital Huntington, West Virginia  25701
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Hematology Oncology Associates of the Quad Cities Bettendorf, Iowa  52722
Somerset Medical Center Somerville, New Jersey  08876
Battle Creek Health System Cancer Care Center Battle Creek, Michigan  49017
Munson Medical Center Traverse City, Michigan  49684
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
Big Sky Oncology Great Falls, Montana  59405
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Veterans Affairs Medical Center - Hines Hines, Illinois  60141
New York Weill Cornell Cancer Center at Cornell University New York, New York  10021
Butterworth Hospital at Spectrum Health Grand Rapids, Michigan  49503-2560
Masonic Cancer Center at University of Minnesota Minneapolis, Minnesota  55455
University of Mississippi Cancer Clinic Jackson, Mississippi  39216-4505
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
CCOP - Nevada Cancer Research Foundation Las Vegas, Nevada  89109-2306
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
Madigan Army Medical Center - Tacoma Tacoma, Washington  98431
West Virginia University Health Sciences Center - Charleston Charleston, West Virginia  25302
Gundersen Lutheran Center for Cancer and Blood La Crosse, Wisconsin  54601
Methodist Estabrook Cancer Center Omaha, Nebraska  68114-4199
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
Helen and Harry Gray Cancer Center at Hartford Hospital Hartford, Connecticut  06102-5037
Elkhart General Hospital Elkhart, Indiana  46515
Howard Community Hospital Kokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. Joseph St. Joseph, Michigan  49085
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Marlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West Jersey Voorhees, New Jersey  08043
Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497
University Medical Center of Southern Nevada Las Vegas, Nevada  89102
Peninsula Medical Center Burlingame, California  94010
Sutter Health - Western Division Cancer Research Group Greenbrae, California  94904
California Pacific Medical Center - California Campus San Francisco, California  94118
Sutter Solano Medical Center Vallejo, California  94589
Ella Milbank Foshay Cancer Center at Jupiter Medical Center Jupiter, Florida  33458
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte, Indiana  46350
Genesis Regional Cancer Center at Genesis Medical Center Davenport, Iowa  52803
St. Francis Comprehensive Cancer Center Topeka, Kansas  66606
Pennington Cancer Center at Baton Rouge General Baton Rouge, Louisiana  70806
Mary Bird Perkins Cancer Center - Baton Rouge Baton Rouge, Louisiana  70809
Medical Center of Louisiana - New Orleans New Orleans, Louisiana  70112
Mecosta County Medical Center Big Rapids, Michigan  49307
Coborn Cancer Center Saint Cloud, Minnesota  56303
CentraCare Clinic - River Campus St. Cloud, Minnesota  56303
Immanuel Medical Center Omaha, Nebraska  68122
Creighton University Medical Center Omaha, Nebraska  68131-2197
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
Iredell Memorial Hospital Statesville, North Carolina  28677
Forsyth Regional Cancer Center at Forsyth Medical Center Winston-Salem, North Carolina  27103
Kaiser Permanente Health Care - Portland Portland, Oregon  97232
Bon Secours St. Francis Health System Greenville, South Carolina  29601
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center Kingsport, Tennessee  37662
Mountainview Medical Berlin, Vermont  05602
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital Fairbanks, Alaska  99701
Denver Health Medical Center Denver, Colorado  80204-4507
Montrose Memorial Hospital Cancer Center Montrose, Colorado  81401
St. Francis Hospital Federal Way, Washington  98003
Cascade Cancer Center at Evergreen Hospital Medical Center Kirkland, Washington  98034-3013
St. Clare Hospital Lakewood, Washington  98499-0998
Providence St. Peter Hospital Regional Cancer Center Olympia, Washington  98506
Good Samaritan Cancer Center Puyallup, Washington  98371
Allenmore Hospital Tacoma, Washington  98411-0414
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Tampa, Florida  33612
Cancer Resource Center - Lincoln Lincoln, Nebraska  68510
Alta Bates Summit Comprehensive Cancer Center Berkeley, California  94704
Eastern Connecticut Hematology and Oncology Associates Norwich, Connecticut  06360
Tunnell Cancer Center at Beebe Medical Center Lewes, Delaware  19958
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Fort Lauderdale, Florida  33308
Michiana Hematology-Oncology, PC - Elkhart Elkhart, Indiana  46514
Elkhart Clinic, LLC Elkhart, Indiana  46514-2098
Michiana Hematology Oncology PC - La Porte La Porte, Indiana  46350
Michiana Hematology-Oncology, PC - South Bend Mishawaka, Indiana  46545-1470
Michiana Hematology Oncology PC - Plymouth Plymouth, Indiana  46563
Tammy Walker Cancer Center at Salina Regional Health Center Salina, Kansas  67401
Foote Memorial Hospital Jackson, Michigan  49201
St. Mary Mercy Hospital Livonia, Michigan  48154
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Lakeside Cancer Specialists, PLLC Saint Joseph, Michigan  49085
Willmar Cancer Center at Rice Memorial Hospital Willmar, Minnesota  56201
Truman Medical Center - Hospital Hill Kansas City, Missouri  64108
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha, Nebraska  68124
Frederick R. and Betty M. Smith Cancer Treatment Center Sparta, New Jersey  07871
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus, Ohio  43210-1240
Southwest Virginia Regional Cancer Center at Wellmonth Health Norton, Virginia  24273
Providence Centralia Hospital Centralia, Washington  98531-9027
Franciscan Cancer Center at St. Joseph Medical Center Tacoma, Washington  98405-3004
Rocky Mountain Oncology Casper, Wyoming  82609
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
Queen's Cancer Institute at Queen's Medical Center Honolulu, Hawaii  96813
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Union Hospital of Cecil County Elkton MD, Maryland  21921
Duke Cancer Institute Durham, North Carolina  27710
Kinston Medical Specialists Kinston, North Carolina  28501
MBCCOP - Meharry Medical College - Nashville Nashville, Tennessee  37208-3599
Providence Cancer Center Anchorage, Alaska  99508
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
Roper St. Francis Cancer Center at Roper Hospital Charleston, South Carolina  29401
Rockwood Clinic Cancer Treatment Center Spokane, Washington  99204-2967
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Berkshire Hematology Oncology, PC Pittsfield, Massachusetts  01201
Lynchburg Hematology-Oncology Clinic Lynchburg, Virginia  24501
Tahoe Forest Cancer Center Truckee, California  96161
Kapiolani Medical Center at Pali Momi Aiea, Hawaii  96701
Kapiolani Medical Center for Women and Children Honolulu, Hawaii  96826
Straub Clinic and Hospital, Incorporated Honolulu, Hawaii  96813
Hawaii Medical Center - East Honolulu, Hawaii  96817
OnCare Hawaii, Incorporated - Kuakini Honolulu, Hawaii  96817
OnCare Hawaii, Incorporated - Lusitana Honolulu, Hawaii  96813
Maui Memorial Medical Center Wailuku, Hawaii  96793
Pacific Cancer Institute - Maui Wailuku, Hawaii  96793
Mercy General Health Partners Muskegon, Michigan  49443
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Concord, New Hampshire  03301
New Hampshire Oncology - Hematology, PA - Hooksett Hooksett, New Hampshire  03106
Bay Area Hospital Coos Bay, Oregon  97420
AnMed Cancer Center Anderson, South Carolina  29621
University of Colorado Cancer Center at UC Health Sciences Center Aurora, Colorado  80045
Cleveland Clinic Florida - Weston Weston, Florida  33331
Veterans Affairs Medical Center - West Haven West Haven, Connecticut  06516
Hematology Oncology Associates, PC Albuquerque, New Mexico  87106
Minnesota Oncology - Maplewood Maplewood, Minnesota  55109
Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
Lakeview Hospital Stillwater, Minnesota  55082
Minnesota Oncology - Woodbury Woodbury, Minnesota  55125
Mount Carmel Regional Cancer Center Pittsburg, Kansas  66762
Shaw Regional Cancer Center Edwards, Colorado  81632
Tufts Medical Center Cancer Center Boston, Massachusetts  02111
Kansas City Cancer Centers - Southwest Overland Park, Kansas  66210
Valley View Hospital Cancer Center Glenwood Springs, Colorado  81601
Castle Medical Center Kailua, Hawaii  96734
Kauai Medical Clinic Lihue, Hawaii  96766
Central Dupage Cancer Center Warrenville, Illinois  60555
Hays Medical Center Hays, Kansas  67601
Hutchinson Hospital Corporation Hutchinson, Kansas  67502
Lakeside Hospital Omaha, Nebraska  68130
Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital Albuquerque, New Mexico  87110
New Ulm Medical Center New Ulm, Minnesota  56073
Pacific Medical Center Seattle, Washington  98104
Kansas City Cancer Centers - North Kansas City, Missouri  64154
Kansas City Cancer Centers - South Kansas City, Missouri  64131
St. Rose Ambulatory and Surgery Center Great Bend, Kansas  67530
Kansas City Cancer Centers - West Kansas City, Kansas  66112
Kansas City Cancer Center - Shawnee Mission Shawnee Mission, Kansas  66204
Kansas City Cancer Centers - East Lee's Summit, Missouri  64064
Spectrum Health Reed City Hospital Reed City, Michigan  49677
Idaho Urologic Institute, PA Meridian, Idaho  83642
Delnor Hospital - Geneva Geneva, Illinois  60134
Sutter Pacific Medical Foundation Santa Rosa, California  95403
Cleveland Regional Medical Center Shelby, North Carolina  28150
Benefis Sletten Cancer Institute Great Falls, Montana  59405
Carolinas Medical Center - Union Monroe, North Carolina  28112
Seattle Cancer Care Alliance at EvergreenHealth Kirkland, Washington  98034