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A Phase III Randomized Study of Patients With High Risk, Hormone-Naive Prostate Cancer: Androgen Blockade With 4 Cycles of Immediate Chemotherapy Versus Androgen Blockade With Delayed Chemotherapy


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

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Trial Information

A Phase III Randomized Study of Patients With High Risk, Hormone-Naive Prostate Cancer: Androgen Blockade With 4 Cycles of Immediate Chemotherapy Versus Androgen Blockade With Delayed Chemotherapy


OBJECTIVES:

Primary

- Compare the survival of patients with high-risk hormone-naive prostate cancer treated
with androgen blockade with concurrent chemotherapy vs delayed chemotherapy.

Secondary

- Compare biochemical control in patients treated with these regimens.

- Determine the toxicity of these regimens in these patients.

- Compare the time to clinical failure, as measured by progression on bone scan or CT
scan or a prostate-specific antigen doubling time of ≤ 32 weeks, in patients treated
with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
therapy (surgery vs radiotherapy and/or brachytherapy vs both), original combined Gleason
score (6 vs 7 vs 8-10), and prior vaccine therapy (yes vs no). Patients are randomized to 1
of 2 treatment arms.

- Arm I: Patients receive androgen blockade (AB) comprising a luteinizing-hormone
releasing-hormone agonist continuously and oral flutamide or oral bicalutamide once
daily for at least 1 month. Within 4 weeks of initiation of AB, patients begin
chemotherapy. Patients receive 1, and only 1, of the following chemotherapy regimens:

- Regimen A: Patients receive oral estramustine 3 times daily on days 1-5 and
docetaxel IV on day 3. Treatment repeats every 21 days for 4 courses in the
absence of disease progression or unacceptable toxicity.

- Regimen B: Patients receive oral estramustine 3 times daily on days 1-5 and
paclitaxel IV on days 3, 10, 17, 24, 31, and 38. Treatment repeats every 56 days
for 4 courses in the absence of disease progression or unacceptable toxicity.

- Regimen C: Patients receive oral ketoconazole 3 times daily on days 1-7, 15-21,
and 29-35; doxorubicin IV on days 1, 15, and 29; vinblastine IV on days 8, 22, and
36; and oral estramustine 3 times daily on days 8-14, 22-28, and 36-42. Treatment
repeats every 56 days for 4 courses in the absence of disease progression or
unacceptable toxicity.

- Regimen D: Patients receive oral estramustine 3 times daily on days 1-4 and
docetaxel IV over 1 hour on days 3, 10, and 17. Treatment repeats every 28 days
for 4 courses in the absence of disease progression or unacceptable toxicity.

- Regimen E: Patients receive docetaxel IV on day 1. Treatment repeats every 21 days
for 4 courses in the absence of disease progression or unacceptable toxicity.

- Regimen F: Patients receive docetaxel IV on days 1, 8, and 15. Treatment repeats
every 28 days for 4 courses in the absence of disease progression or unacceptable
toxicity.

- Regimen G: With approval from the protocol chair, patients may receive a regimen
that has been demonstrated in a published phase II study to have at least a 50%
response rate as measured by PSA decrease from baseline over 2 measurements 28
days apart or a decrease in measurable soft tissue disease by 50% in 2 dimensions.

- Arm II: Patients receive AB as in arm I. Patients continue with AB until clinical
failure, at which time patients receive chemotherapy as in arm I. Patients who have a
response may continue to receive chemotherapy beyond 4 courses.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 1,050 patients will be accrued for this study within 4-6
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of adenocarcinoma of the prostate

- Failed local treatments (surgery and/or radiotherapy and/or brachytherapy) as
defined by a rising prostate-specific antigen level of at least 2.0 ng/mL
(confirmed by 2 measurements at least 2 weeks apart) and a doubling time of 32
weeks or less

- No clinical or radiographic evidence of disease

- Original Gleason score of at least 7 OR Gleason score of 6 with capsular
penetration or positive seminal vesicles or lymph nodes

- No metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 10 g/dL

- No history of bleeding disorders that would contraindicate warfarin, including
clotting factor defects

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- AST/ALT no greater than 1.5 times upper limit of normal

Renal:

- Creatinine no greater than 1.5 mg/dL

- BUN no greater than 1.2 times normal

Cardiovascular:

- No symptomatic heart disease

- No history of myocardial infarction

- No history of thromboembolic events (e.g., deep vein thrombosis, symptomatic
cerebrovascular events, or pulmonary embolism)

Other:

- No other major medical or psychiatric illness that would preclude study entry

- No other prior or concurrent invasive malignancy within the past 5 years except
superficial skin cancer

- No history of esophageal varices

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 6 weeks since prior vaccine therapy

Chemotherapy:

- At least 5 years since prior chemotherapy

Endocrine therapy:

- Prior adjuvant or neoadjuvant hormonal therapy of less than 8 months duration allowed

- At least 1 year since prior androgen therapy

Radiotherapy:

- See Disease Characteristics

- At least 5 years since prior radiotherapy to sites other than prostate

Surgery:

- See Disease Characteristics

Other:

- Concurrent warfarin allowed

- Concurrent bisphosphonate therapy initiated prior to or after randomization allowed

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Kenneth J. Pienta, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069186

NCT ID:

NCT00030654

Start Date:

October 2002

Completion Date:

Related Keywords:

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

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
Boulder Community HospitalBoulder, Colorado  80301-9019
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
Porter Adventist HospitalDenver, Colorado  80210
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
St. Joseph HospitalDenver, Colorado  80218
Swedish Medical CenterEnglewood, Colorado  80110
Sky Ridge Medical CenterLone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United HospitalLongmont, Colorado  80502
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Rapid City Regional HospitalRapid City, South Dakota  57709
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
Memorial Hospital Cancer CenterColorado Springs, Colorado  80909
Gulf Coast Cancer Treatment CenterPanama City, Florida  32405-4587
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
Cancer Research for the OzarksSpringfield, Missouri  65807
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
Mercy Hospital Cancer Center - ScrantonScranton, Pennsylvania  18501
CCOP - GreenvilleGreenville, South Carolina  29615
University of Texas Medical BranchGalveston, Texas  77555-1329
Dixie Regional Medical CenterSaint George, Utah  84770
University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida  33136
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee  37232-2516
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Veterans Affairs Medical Center - CharlestonCharleston, South Carolina  29401-5799
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - MemphisMemphis, Tennessee  38104
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Foundation for Cancer Research and EducationPhoenix, Arizona  85013
Veterans Affairs Medical Center - AmarilloAmarillo, Texas  79106
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Midlands Cancer Center at Midlands Community HospitalPapillion, Nebraska  68128-4157
CCOP - Colorado Cancer Research Program, IncorporatedDenver, Colorado  80224
Veterans Affairs Medical Center - Tampa (Haley)Tampa, Florida  33612
Mercy Fitzgerald HospitalDarby, Pennsylvania  19023
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
Tallahassee Memorial HospitalTallahassee, Florida  32308
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
Veterans Affairs Medical Center - Little RockLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - HinesHines, Illinois  60141
Shands Cancer Center at the University of Florida Health Science CenterGainesville, Florida  32610-0296
St. Mary-Corwin Regional Medical CenterPueblo, Colorado  81004
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Wendt Regional Cancer Center at Finley HospitalDubuque, Iowa  52001
Akron City Hospital at Summa Health SystemAkron, Ohio  44304
Cancer Treatment CenterWooster, Ohio  44691
All Saints Cancer Center at All Saints HealthcareRacine, Wisconsin  53405
Medical Center of Aurora - South CampusAurora, Colorado  80012-0000
Rocky Mountain Cancer Centers - Denver RoseDenver, Colorado  80220
Rocky Mountain Cancer Centers - ThorntonThornton, Colorado  80229
Lipson Cancer and Blood Center at Rochester General HospitalRochester, New York  14621
Akron General's McDowell Cancer CenterAkron, Ohio  44302
Cancer Care Center, IncorporatedSalem, Ohio  44460
Erlanger Cancer CenterChattanooga, Tennessee  37403