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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: 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 Hormones Flutamide Bicalutamide

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
  • 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 1, 2017