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Summary

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

Description

Summary

RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving hypofractionated radiation therapy (higher doses over a shorter period of time), may be less costly with fewer side effects and just as effective in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying several different radiation therapy regimens to compare how well they work in treating patients with stage II prostate cancer.

Official Title

A Phase III Randomized Study of Hypofractionated 3D-CRT/MRT Versus Conventionally Fractionated 3D-CRT/MRT in Patients With Favorable-Risk Prostate Cancer

Details

OBJECTIVES:

Primary

  • Compare the disease-free survival (DFS) of patients with favorable-risk stage II prostate cancer treated with hypofractionated vs conventionally fractionated three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT).

Secondary

  • Compare time to local progression, freedom from biochemical recurrence, and disease-specific and overall survival of patients treated with these regimens.
  • Determine the incidence of gastrointestinal and genitourinary toxic effects in patients treated with these regimens.
  • Compare the degree, duration, and significant differences in disease-specific health-related quality of life (HRQOL) decrements, using the Expanded Prostate Cancer Index Composite (EPIC), in patients treated with these regimens.
  • Determine whether anxiety and/or depression, as measured by the Hopkins Symptom Checklist-25 (HSCL-25), are decreased with therapy that improves DFS of these patients .
  • Determine whether the incremental gain in DFS outweighs decrements in the generic domains of HRQOL (i.e., mobility, self care, usual activities, pain/discomfort, and anxiety/depression) in patients treated with these regimens.
  • Conduct a cost-utility analysis of hypofractionated 3D-CRT or IMRT as a prostate cancer therapy if this regimen is shown to be as effective as conventionally fractionated 3D-CRT or IMRT in improving DFS.

OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to Gleason score (2-4 vs 5-6), prostate-specific antigen (PSA) level (< 4 ng/mL vs 4-<9 ng/mL), and planned radiotherapy modality (three-dimensional conformal radiotherapy [3D-CRT] vs intensity-modulated radiotherapy [IMRT]). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo conventionally fractionated 3D-CRT or IMRT once daily 5 days a week for 8.2 weeks (total of 41 treatments).
  • Arm II: Patients undergo hypofractionated 3D-CRT or IMRT once daily 5 days a week for 5.6 weeks (total of 28 treatments).

Quality of life, anxiety, and depression are assessed at baseline and then at 6 months and 1, 2, and 5 years after the start of radiotherapy.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,067 patients will be accrued to this study.

Keywords

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

Eligibility

For males ages 18–120

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate within the past 6 months
  • Clinical stage T1-2c
  • Combined Gleason score 2-6
  • Prostate-specific antigen (PSA) < 10 ng/mL within the past 6 months
  • PSA evaluated at least 10 days after prostate biopsy
  • For patients who received finasteride, PSA evaluated at least 30 after completion of finasteride
  • For patients who received dutasteride, PSA evaluated at least 90 after completion of dutasteride
  • No regional lymph node involvement
  • No distant metastases

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • No unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
  • No transmural myocardial infarction within the past 6 months
  • No acute bacterial or fungal infection requiring IV antibiotics
  • No chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study treatment
  • No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • No known AIDS
  • No prior or concurrent lymphomatous/hematogenous malignancy or other invasive malignancy except nonmelanomatous skin cancer or any other cancer for which the patient has been continually disease-free for ≥ 5 years (e.g., carcinoma in situ of the bladder or oral cavity)
  • No other severe, active comorbidity

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior radical prostatectomy or cryosurgery for prostate cancer
  • No prior hormonal therapy, including any of the following:
  • Luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide)
  • Antiandrogens (e.g., flutamide or bicalutamide)
  • Estrogens [e.g., diethylstilbestrol (DES)]
  • Surgical castration (bilateral orchiectomy)
  • No prior pelvic radiotherapy or prostate brachytherapy
  • No prior or concurrent cytotoxic chemotherapy for prostate cancer
  • At least 30 days since prior finasteride
  • At least 90 days since prior dutasteride
  • No concurrent neoadjuvant or adjuvant hormonal therapy
  • Concurrent warfarin or other blood-thinning agents allowed

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
  • 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
  • Marin Cancer Institute at Marin General Hospital
    Greenbrae, California, 94904, United States
  • Sutter Health - Western Division Cancer Research Group
    Greenbrae, California, 94904, 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
  • Doctors Medical Center - San Pablo Campus
    San Pablo, California, 94806, 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
  • 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 Solano Medical Center
    Vallejo, California, 94589, United States
  • Valley Medical Oncology
    Fremont, California, 94538, United States
  • Valley Medical Oncology Consultants - Pleasanton
    Pleasanton, California, 94588, 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
  • General Robert Huyser Cancer Center at David Grant Medical Center
    Travis AFB, California, 94535-1800, 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
  • University of California Davis Cancer Center
    Sacramento, California, 95817, 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 Cardova, 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
  • Radiation Oncology Associates - Reno
    Reno, Nevada, 89509, United States
  • Saint Mary's Regional Medical Center
    Reno, Nevada, 89503, United States
  • Providence Saint Joseph Medical Center - Burbank
    Burbank, California, 91505, United States
  • Kaiser Permanente Medical Center - Los Angeles
    Los Angeles, California, 90027, United States
  • Veterans Affairs Medical Center - Long Beach
    Long Beach, California, 90822, 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
NCT00331773
Phase
Phase 3
Lead Scientist
Mack Roach
Study Type
Interventional
Last Updated
February 1, 2017