Summary

for males ages 18-120 (full criteria)
at San Francisco, California and other locations
study started
Mack Roach

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 Prostatic Neoplasms Conventional 3D-CRT or IMRT Hypofractionated 3D-CRT or IMRT Hypofractionated 3D-CRT

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

  • UCSF Helen Diller Family Comprehensive Cancer Center
    San Francisco California 94115 United States
  • 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 Air Force Base 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

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
March 14, 2018