Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005044
First received: April 6, 2000
Last updated: February 18, 2011
Last verified: September 2003
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: bicalutamide
Drug: flutamide
Drug: releasing hormone agonist therapy
Procedure: neoadjuvant therapy
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2000
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005044

  Show 261 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Michael G. Haddock, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Paner GP, Bae K, Grignon DJ, et al.: Trends in Gleason grading of prostate cancer (PCa): analysis of reporting by institutional and central review pathologists in four Radiation Therapy Oncology Group (RTOG) protocols spanning 17 years and 2094 needle biopsies (bxs). [Abstract] United States and Canadian Academy of Pathology 96th Annual Meeting, March 24-30, 2007, San Diego, CA. A-766, 2007.

ClinicalTrials.gov Identifier: NCT00005044     History of Changes
Other Study ID Numbers: CDR0000067635, RTOG-9910
Study First Received: April 6, 2000
Last Updated: February 18, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Flutamide
Bicalutamide
Hormones
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014