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A Phase III Protocol of Androgen Suppression (AS) and Radiation Therapy (RT) vs AS and RT Followed by Chemotherapy With Paclitaxel, Estramustine, and Etoposide (TEE) for Localized, High-Risk, Prostate Cancer


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

Thank you

Trial Information

A Phase III Protocol of Androgen Suppression (AS) and Radiation Therapy (RT) vs AS and RT Followed by Chemotherapy With Paclitaxel, Estramustine, and Etoposide (TEE) for Localized, High-Risk, Prostate Cancer


OBJECTIVES:

- Compare the efficacy of androgen suppression and radiotherapy with or without
subsequent paclitaxel, estramustine, and etoposide, in terms of overall and
disease-free survival, biochemical and local control, and freedom from distant
metastasis, in patients with localized high-risk prostate cancer.

- Compare the toxic effects of these regimens in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to prostate-specific
antigen level (≤ 10 ng/mL vs 11-100 ng/mL), tumor stage (T1-2 vs T3-4), Gleason score (7 vs
8-10), and prior hormone use (yes vs no). Patients are randomized to one of two treatment
arms.

All patients receive androgen suppression comprising a luteinizing hormone-releasing hormone
(LHRH) agonist AND bicalutamide OR flutamide for 4 months. Beginning 8 weeks after the
initiation of androgen suppression, all patients undergo radiotherapy once daily, 5 days a
week, for 7-8 weeks. Patients who received prior androgen suppression therapy count time to
radiotherapy from start date of prior hormonal therapy.

- Arm I: Patients continue androgen suppression therapy (LHRH agonist only) for
approximately 20 more months after radiotherapy is completed.

- Arm II: Patients continue therapy as in arm I and receive chemotherapy beginning 28
days after completing radiotherapy. Chemotherapy comprises oral estramustine 3 times
daily and oral etoposide twice daily on days 1-14 and paclitaxel IV over 1 hour on day
2. Chemotherapy repeats every 21 days for 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 1,440 patients will be accrued for this study within 6 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven prostate cancer at high risk for relapse as determined by
either of the following:

- Prostate-specific antigen (PSA) 20-100 ng/mL and Gleason score at least 7 (any T
stage)

- Clinical stage at least T2, Gleason score at least 8, and PSA no greater than
100 ng/mL

- Negative lymph nodes

- No metastatic disease

PATIENT CHARACTERISTICS:

Age:

- Over 18

Performance status:

- Zubrod 0 or 1

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 3,000/mm^3

- Platelet count at least 130,000/mm^3

- Hemoglobin at least 11.4 g/dL

Hepatic:

- AST no greater than 2 times upper limit of normal

Renal:

- Creatinine no greater than 2.5 mg/dL

Other:

- No other invasive cancer within the past 5 years except superficial nonmelanomatous
skin cancer

- No major medical or psychiatric illness that would preclude study participation

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- At least 5 years since prior chemotherapy

Endocrine therapy:

- At least 60 days since prior finasteride for prostatic hypertrophy

- At least 90 days since prior testosterone

- No more than 30 days since initiation of prior pharmacologic androgen ablation for
prostate cancer

Radiotherapy:

- No prior pelvic radiotherapy

- No concurrent intensity-modulated radiotherapy

Surgery:

- No prior radical prostatectomy

- No prior cryosurgery for prostate cancer

- No prior orchiectomy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Howard M. Sandler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067250

NCT ID:

NCT00004054

Start Date:

January 2000

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

Name

Location

Akron City HospitalAkron, Ohio  44304
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
St. Luke's Medical CenterMilwaukee, Wisconsin  53215
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
Methodist Cancer Center at Methodist HospitalIndianapolis, Indiana  46202
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
CCOP - OchsnerNew Orleans, Louisiana  70121
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Mount Diablo Medical CenterConcord, California  94524-4110
Sutter Health Western Division Cancer Research GroupGreenbrae, California  94904
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
Baptist Hospital of MiamiMiami, Florida  33176-2197
Lutheran General Cancer Care CenterPark Ridge, Illinois  60068
Mary Bird Perkins Cancer CenterBaton Rouge, Louisiana  70809
Anne Arundel Oncology CenterAnnapolis, Maryland  21401
Greater Baltimore Medical Center and Cancer CenterBaltimore, Maryland  21204
Marquette General HospitalMarquette, Michigan  49855
Akron General Medical CenterAkron, Ohio  44302
CCOP - ColumbusColumbus, Ohio  43206
CCOP - DaytonKettering, Ohio  45429
Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
Dixie Regional Medical CenterSaint George, Utah  84770
LDS HospitalSalt Lake City, Utah  84143
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Foundation for Cancer Research and EducationPhoenix, Arizona  85013
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
South Jersey Regional Cancer CenterMillville, New Jersey  08332
Atlantic City Medical CenterPomona, New Jersey  08240
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
St. Luke's Hospital Cancer CenterBethlehem, Pennsylvania  18015
Wellspan Health - York Cancer CenterYork, Pennsylvania  17403
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Fox Chase Cancer Center at St. Francis Medical CenterTrenton, New Jersey  08629
John and Dorothy Morgan Cancer Center at Lehigh Valley HospitalAllentown, Pennsylvania  18105
All Saints Cancer Center at All Saints HealthcareRacine, Wisconsin  53405
Ball Memorial Hospital Cancer CenterMuncie, Indiana  47303-3499