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Summary

for males ages 18–120 (full criteria)
at Fresno, California and other locations
study started

Description

Summary

RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of hormone therapy and radiation therapy is more effective for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of hormone therapy and radiation therapy in treating patients who have prostate cancer.

Official Title

A Phase III Trial to Evaluate the Duration of Neoadjuvant Total Androgen Suppression (TAS) and Radiation Therapy (RT) in Intermediate-Risk Prostate Cancer

Details

OBJECTIVES:

  • Compare the efficacy of moderate-duration (28 weeks) neoadjuvant total androgen suppression (TAS) and radiotherapy (RT) with short-duration (8 weeks) neoadjuvant TAS and RT, as related to disease-specific survival, in patients with intermediate-risk adenocarcinoma of the prostate.
  • Compare these regimens, in terms of overall survival, disease-free survival, time to local tumor progression or distant failure, time to first biochemical failure, hormone-refractory state, and treatment-induced morbidity, in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prostate-specific antigen level (no greater than 10 ng/mL vs greater than 10 but no greater than 20 ng/mL vs greater than 20 ng/mL), tumor stage (T1b-2 vs T3-4), Gleason score (2-4 vs 5-6 vs 7-10), and prior hormonal therapy (yes vs no). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive total androgen suppression for 8 weeks prior to the initiation of radiotherapy and throughout radiotherapy. A luteinizing hormone-releasing hormone (LHRH) agonist is administered every 1-3 months AND bicalutamide OR flutamide is given orally daily for a total duration of 16 weeks. Beginning with week 9, patients undergo radiotherapy 5 days a week for 8 weeks.
  • Arm II: Patients receive total androgen suppression for 28 weeks prior to the initiation of radiotherapy and throughout radiotherapy. An LHRH agonist AND bicalutamide OR flutamide are administered as in arm I for a total duration of 36 weeks. Beginning with week 29, patients undergo radiotherapy as in arm I.

Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,540 patients (770 per treatment arm) will be accrued for this study within 4 years.

Keywords

Prostate Cancer adenocarcinoma of the prostate stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer Prostatic Neoplasms Hormones Bicalutamide Flutamide

Eligibility

For males ages 18–120

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate
  • Intermediate risk for disease relapse as determined by any of the following combination of factors:
  • T1b-4, Gleason score 2-6, and prostate-specific antigen (PSA) greater than 10 but no greater than 100 ng/mL
  • T1b-4, Gleason score 7, and PSA less than 20 ng/mL
  • T1b-1c, Gleason score 8-10, and PSA less than 20 ng/mL
  • Must have disease confirmation within 180 days of study randomization
  • Clinically negative lymph nodes (N0) as established by imaging or negative lymph nodes by nodal sampling or dissection
  • Radiologic or radioimmunoscintigraphy findings suggestive of regional nodal involvement allowed provided cytologic or histologic evaluation shows no evidence of a neoplastic process
  • Equivocal radiologic findings (i.e., maximum nodal size no greater than 1.5 cm)allowed
  • No distant metastases (M0)
  • Radionuclide imaging findings suggestive but not diagnostic of metastatic disease allowed provided radiologic imaging does not confirm metastatic disease

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0 or 1

Life expectancy:

  • At least 10 years

Hematopoietic:

  • Not specified

Hepatic:

  • ALT no greater than 2 times upper limit of normal

Renal:

  • Not specified

Other:

  • Fertile patients must use effective contraception
  • No other concurrent medical illness that would result in a life expectancy of less than 10 years
  • No other invasive malignancy within the past 5 years except localized basal cell or squamous cell skin cancer
  • No other concurrent major medical or psychiatric illness that would preclude study treatment or follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy for prostate cancer

Endocrine therapy:

  • No prior androgen-deprivation therapy except luteinizing hormone-releasing hormone(LHRH) agonist AND bicalutamide OR flutamide provided:
  • LHRH agonist was initiated no more than 30 days before study randomization and bicalutamide OR flutamide was initiated no more than 14 days before or after LHRH agonist administration
  • No concurrent finasteride for prostatic hypertrophy

Radiotherapy:

  • No prior pelvic external beam radiotherapy
  • No prior radionuclide prostate brachytherapy
  • No concurrent intensity-modulated radiotherapy

Surgery:

  • No prior prostatectomy
  • No prior prostatic cryosurgery
  • No prior bilateral orchiectomy

Other:

  • No other concurrent medical research study involving prostate cancer treatment

Locations

  • California Cancer Center
    Fresno, California, 93720, United States
  • Saint Agnes Cancer Center
    Fresno, California, 93720, United States
  • UCSF Comprehensive Cancer Center
    San Francisco, California, 94115, United States
  • CCOP - Bay Area Tumor Institute
    Oakland, California, 94609-3305, United States
  • Sutter Health Western Division Cancer Research Group
    Greenbrae, California, 94904, United States
  • Mount Diablo Medical Center
    Concord, California, 94524-4110, United States
  • O'Connor Hospital
    San Jose, California, 95128, United States
  • David Grant Medical Center
    Travis Air Force Base, California, 94535, United States
  • CCOP - Santa Rosa Memorial Hospital
    Santa Rosa, California, 95403, United States
  • Radiation Oncology Center - Sacramento
    Sacramento, California, 95816, United States
  • Providence Saint Joseph Medical Center - Burbank
    Burbank, California, 91505, United States
  • Huntington Cancer Center at Huntington Hospital
    Pasadena, California, 91105, United States
  • USC/Norris Comprehensive Cancer Center and Hospital
    Los Angeles, California, 90033-0804, United States
  • City of Hope Comprehensive Cancer Center
    Duarte, California, 91010-3000, United States
  • Robert and Beverly Lewis Family Cancer Care Center
    Pomona, California, 91767, United States
  • Torrance Memorial Medical Center
    Torrance, California, 90505, United States
  • Jonsson Comprehensive Cancer Center, UCLA
    Los Angeles, California, 90095-1714, United States
  • Veterans Affairs Medical Center - Long Beach
    Long Beach, California, 90822, United States
  • Loma Linda University Cancer Institute at Loma Linda University Medical Center
    Loma Linda, California, 92354, United States
  • CCOP - Southern Nevada Cancer Research Foundation
    Las Vegas, Nevada, 89106, United States
  • Comprehensive Cancer Centers of Nevada
    Las Vegas, Nevada, 89109, United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Radiation Therapy Oncology Group
ID
NCT00005044
Phase
Phase 3
Lead Scientist
Mack Roach
Study Type
Interventional
Last Updated
March 9, 2017