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A Phase II Study of External Beam Radiation Therapy Combined With Permanent Source Brachytherapy for Intermediate Risk Clinically Localized Adenocarcinoma of the Prostate

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

A Phase II Study of External Beam Radiation Therapy Combined With Permanent Source Brachytherapy for Intermediate Risk Clinically Localized Adenocarcinoma of the Prostate

OBJECTIVES: I. Determine the acute and late grade 3-5 genitourinary and gastrointestinal
toxic effects of external beam radiotherapy followed by permanent source brachytherapy using
interstitial iodine I 125 seeds in patients with intermediate risk, clinically localized
adenocarcinoma of the prostate. II. Determine the freedom from PSA failure, overall
survival, disease specific survival, and local and/or distant clinical relapse rates in
patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients undergo external beam radiotherapy (EBRT) to
the pelvis 5 days a week for 5 weeks. Permanent source brachytherapy comprised of
ultrasound-guided implantation of iodine I 125 seeds into the prostate is performed 2-6
weeks after completion of EBRT. Patients are followed at 1, 3, 6, 9, and 12 months, then
every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study within 1 year.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven locally confined adenocarcinoma of the
prostate Clinical stage T1c-T2b, NX or N0, M0 Gleason score 2-6 AND PSA greater than 10
ng/dL but no greater than 20 ng/dL OR Gleason score 7 AND PSA no greater than 20 ng/dL
Prostate volume no greater than 60 mL by transrectal ultrasound prior to external beam
radiotherapy American Urologic Association voiding symptoms score no greater than 18 No
distant metastases

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Zubrod 0-1 Life expectancy: Not
specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other:
No hip prosthesis No other malignancy within the past 5 years except basal cell or
squamous cell skin cancer No major medical or psychiatric illness that would preclude
study Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Prior induction hormonal therapy allowed only if started
no more than 6 months prior to study Radiotherapy: See Disease Characteristics No prior
radiotherapy to pelvis Surgery: No prior transurethral resection of prostate No radical
surgery for carcinoma of the prostate

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

W. Robert Lee, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University


United States: Federal Government

Study ID:




Start Date:

November 2000

Completion Date:

Related Keywords:

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



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