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A Randomized Trial of Radical Prostatectomy Versus Brachytherapy for Patients With T1c or T2a N0 M0 Prostate Cancer


Phase 3
N/A
75 Years
Not Enrolling
Male
Prostate Cancer

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Trial Information

A Randomized Trial of Radical Prostatectomy Versus Brachytherapy for Patients With T1c or T2a N0 M0 Prostate Cancer


OBJECTIVES:

- Compare overall survival in patients with stage II prostate cancer treated with radical
prostatectomy vs brachytherapy.

- Compare metastasis-free survival and probability of survival without symptoms of
patients treated with these regimens.

- Compare the side effects of these treatment regimens in these patients.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.

- Arm I: Patients undergo radical prostatectomy.

- Arm II: Patients undergo brachytherapy with implanted iodine I 125 or palladium Pd 103
seeds Patients are followed every 6 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,980 patients (990 per treatment arm) will be accrued for
this study within 5.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate within the past 120 days

- T1c-T2a, N0, M0

- No bilateral disease

- Prostate-specific antigen (PSA) no greater than 10 ng/mL

- In patients with prior neoadjuvant hormonal therapy (NHT), PSA must be less than
10 ng/mL prior to therapy

- Gleason score no greater than 6

- Prostate gland less than 60 cc on transrectal ultrasound or with minimal pubic arch
interference OR

- Prostate gland 60 cc or greater prior to NHT allowed if prostate size has been
reduced to less than 60 cc by NHT

PATIENT CHARACTERISTICS:

Age:

- 75 and under

Performance status:

- ECOG 0-2 OR

- Zubrod 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Creatinine no greater than 3 mg/dL

Cardiovascular:

- No significant cardiovascular disease

- No New York Heart Association class III or IV heart disease

Other:

- No other malignancy within the past 5 years except effectively treated basal cell or
squamous cell skin cancer or other malignancy at low risk for recurrence

- No other condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- See Disease Characteristics

- At least 90 days since prior NHT

- Duration of therapy no greater than 120 days

- No concurrent NHT

Radiotherapy:

- No prior radiotherapy to pelvis

Surgery:

- No prior surgery for prostate cancer or benign disease, including:

- Transurethral resection of the prostate

- Transurethral resection of the bladder neck

- Cryotherapy

- Laser ablation

- Microwave therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Paul H. Lange, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Washington

Authority:

United States: Federal Government

Study ID:

CDR0000068851

NCT ID:

NCT00023686

Start Date:

October 2001

Completion Date:

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Washington University School of MedicineSaint Louis, Missouri  63110
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Dixie Regional Medical CenterSaint George, Utah  84770
LDS HospitalSalt Lake City, Utah  84143
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee  37232-2516
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
Madigan Army Medical CenterTacoma, Washington  98431-5048
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Veterans Affairs Medical Center - RichmondRichmond, Virginia  23249
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Southern Illinois University School of MedicineSpringfield, Illinois  62794-9658
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Wellspan Health - York Cancer CenterYork, Pennsylvania  17403
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
American Fork HospitalAmerican Fork, Utah  84003
McKay-Dee Hospital CenterOgden, Utah  84403
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Fletcher Allen Health Care - Medical Center CampusBurlington, Vermont  05401
Kansas Cancer Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7357
Sentara Norfolk General HospitalNorfolk, Virginia  23507
St. Vincent Cancer CenterLittle Rock, Arkansas  72205-5499
Northeast Heights Cancer CenterAlbuquerque, New Mexico  87109