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Eligibility
for males ages 18–120
Location
at San Francisco, California and other locations
Dates
study started
Principal Investigator

Description

Summary

RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Interstitial brachytherapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Combining interstitial brachytherapy with external-beam radiation therapy may kill more tumor cells. It is not yet known whether interstitial brachytherapy is more effective with or without external-beam radiation therapy in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of interstitial brachytherapy with or without external-beam radiation therapy in treating patients who have prostate cancer.

Official Title

A Phase III Study Comparing Combined External Beam Radiation and Transperineal Interstitial Permanent Brachytherapy With Brachytherapy Alone for Selected Patients With Intermediate Risk Prostatic Carcinoma

Details

OBJECTIVES:

  • Compare the 5-year freedom from progression in patients with intermediate-risk prostate cancer treated with interstitial brachytherapy with or without external beam radiotherapy (EBRT).
  • Compare biochemical (i.e., prostate-specific antigen) failure, biochemical failure by the Phoenix definition, disease-specific survival, local progression, and distant metastases in patients treated with these regimens.
  • Compare morbidity and quality of life of patients treated with these regimens.
  • Determine the feasibility of collecting Medicare data in a large RTOG prostate cancer clinical trial for cost effectiveness and cost utility analysis of combined treatment with interstitial brachytherapy and EBRT.
  • Prospectively collect diagnostic biopsy samples from these patients for future biomarker analyses.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (T1c vs T2a or T2b), Gleason score (≤ 6 vs 7), prostate-specific antigen (< 10 ng/mL vs 10-20 ng/mL), and prior neoadjuvant hormonal therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo external beam radiotherapy 5 days a week for 5 weeks. Within 2-4 weeks of radiotherapy, patients undergo interstitial brachytherapy with iodine I 125 or palladium Pd 103 seeds.
  • Arm II: Patients undergo interstitial brachytherapy only, as in arm I. Quality of life is assessed at baseline, at 4, 12, and 24 months, and then annually for 3 years.

After completion of study treatment, patients are followed at 3-5 weeks, at 4, 6, 9, and 12 months, every 6 months for 4 years, and then annually thereafter.

Keywords

Prostate Cancer stage IIB prostate cancer stage IIA prostate cancer adenocarcinoma of the prostate

Eligibility

For males ages 18–120

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate
  • T1c-T2b, N0, M0
  • Intermediate-risk disease, as defined by 1 of the following:
  • Gleason score < 7 AND prostate-specific antigen (PSA) 10-20 ng/mL
  • Gleason score 7 AND PSA < 10 ng/mL
  • No evidence of distant metastases
  • Prostate volume ≤ 60 cc by transrectal ultrasonography
  • American Urological Association voiding symptom score no greater than 15 (alpha blockers allowed)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

    Performance status

  • Zubrod 0-1

    Life expectancy

  • Not specified

    Hematopoietic

  • Not specified

    Hepatic

  • Not specified

    Renal

  • Not specified

    Other

  • Patients must use effective contraception
  • No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ at any other site
  • No major medical or psychiatric illness that would preclude study therapy
  • No hip prosthesis

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

    Chemotherapy

  • No prior chemotherapy

    Endocrine therapy

  • Prior neoadjuvant hormonal therapy allowed provided the following are true:
  • Therapy was initiated within 2-6 months of study enrollment
  • Therapy was no more than 6 months in duration
  • Use of 5-alpha reductase inhibitors (e.g., finasteride) is discontinued before registration
  • No concurrent hormonal therapy

    Radiotherapy

  • No prior pelvic radiotherapy

    Surgery

  • No prior radical surgery for prostate cancer
  • No prior transurethral resection of the prostate
  • No prior cryosurgery

    Other

  • No prior transurethral needle ablation of the prostate
  • No prior transurethral microwave thermotherapy of the prostate

Locations

  • Kaiser Permanente Medical Center - San Francisco Geary Campus
    San Francisco, California, 94115, United States
  • California Pacific Medical Center - California Campus
    San Francisco, California, 94118, United States
  • California Cancer Center - Woodward Park Office
    Fresno, California, 93720, United States
  • Kaiser Permanente Medical Center - South San Francisco
    South San Francisco, California, 94080, United States
  • Alta Bates Summit Medical Center - Summit Campus
    Oakland, California, 94609, United States
  • Bay Area Breast Surgeons, Incorporated
    Oakland, California, 94609, United States
  • CCOP - Bay Area Tumor Institute
    Oakland, California, 94609, United States
  • Larry G Strieff MD Medical Corporation
    Oakland, California, 94609, United States
  • Tom K Lee, Incorporated
    Oakland, California, 94609, United States
  • Alta Bates Summit Comprehensive Cancer Center
    Berkeley, California, 94704, United States
  • Kaiser Permanente Medical Center - Richmond
    Richmond, California, 94801, United States
  • Peninsula Medical Center
    Burlingame, California, 94010, United States
  • Kaiser Permanente - Division of Research - Oakland
    Oakland, California, 94611, United States
  • Kaiser Permanente Medical Center - Oakland
    Oakland, California, 94611, United States
  • Kaiser Foundation Hospital - San Rafael
    San Rafael, California, 94903, United States
  • East Bay Radiation Oncology Center
    Castro Valley, California, 94546, United States
  • Valley Medical Oncology Consultants - Castro Valley
    Castro Valley, California, 94546, United States
  • Kaiser Permanente Medical Center - Hayward
    Hayward, California, 94545, United States
  • Contra Costa Regional Medical Center
    Martinez, California, 94553-3156, United States
  • Kaiser Permanente Medical Center - Redwood City
    Redwood City, California, 94063, United States
  • Kaiser Permanente Medical Center - Walnut Creek
    Walnut Creek, California, 94596, United States
  • Sutter Health - Western Division Cancer Research Group
    Novato, California, 94945, United States
  • Sutter Solano Medical Center
    Vallejo, California, 94589, United States
  • Valley Medical Oncology
    Fremont, California, 94538, United States
  • El Camino Hospital Cancer Center
    Mountain View, California, 94040, United States
  • Kaiser Permanente Medical Center - Santa Clara Kiely Campus
    Santa Clara, California, 95051, United States
  • Santa Clara, California, 95051, United States
  • Rohnert Park Cancer Center
    Rohnert Park, California, 94928, United States
  • Solano Radiation Oncology Center
    Vacaville, California, 95687, United States
  • Kaiser Permanente Medical Center - Santa Teresa
    San Jose, California, 95119, United States
  • Kaiser Permanente Medical Center - Santa Rosa
    Santa Rosa, California, 95403, United States
  • Kaiser Permanente Medical Facility - Stockton
    Stockton, California, 95210, United States
  • South Sacramento Cancer Center
    Sacramento, California, 95823, United States
  • South Sacramento Kaiser-Permanente Medical Center
    Sacramento, California, 95823, United States
  • Mercy General Hospital
    Sacramento, California, 95819, United States
  • Radiological Associates of Sacramento Medical Group, Incorporated
    Sacramento, California, 95815, United States
  • Kaiser Permanente Medical Center - Sacramento
    Sacramento, California, 95825, United States
  • Mercy Cancer Center at Mercy San Juan Medical Center
    Carmichael, California, 95608, United States
  • Kaiser Permanente Medical Center - Rancho Cordova
    Rancho Cordova, California, 95670, United States
  • Kaiser Permanente Medical Center - Roseville
    Roseville, California, 95661, United States
  • Radiation Oncology Center - Roseville
    Roseville, California, 95661, United States
  • Radiation Oncology Centers - Cameron Park
    Cameron Park, California, 95682, United States
  • Auburn Radiation Oncology
    Auburn, California, 95603, United States
  • Renown Institute for Cancer at Renown Regional Medical Center
    Reno, Nevada, 89502, United States
  • Nevada Cancer Institute
    Las Vegas, Nevada, 89135, United States
  • CCOP - Nevada Cancer Research Foundation
    Las Vegas, Nevada, 89106, United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Radiation Therapy Oncology Group
ID
NCT00063882
Phase
Phase 3
Lead Scientist
Mack Roach
Study Type
Interventional
Last Updated
May 1, 2017