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

Phase 3
75 Years
Not Enrolling
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


- 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


- 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



- 75 and under

Performance status:

- ECOG 0-2 OR

- Zubrod 0-2

Life expectancy:

- Not specified


- Not specified


- Not specified


- Creatinine no greater than 3 mg/dL


- No significant cardiovascular disease

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


- 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


Biologic therapy:

- Not specified


- 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


- No prior radiotherapy to pelvis


- 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:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Paul H. Lange, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Washington


United States: Federal Government

Study ID:




Start Date:

October 2001

Completion Date:

Related Keywords:

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



Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
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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
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Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Veterans Affairs Medical Center - RichmondRichmond, Virginia  23249
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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
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Kansas Cancer Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7357
Sentara Norfolk General HospitalNorfolk, Virginia  23507
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