Hormone Therapy Followed By Internal Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00032006
First received: March 8, 2002
Last updated: February 18, 2011
Last verified: October 2003
  Purpose

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin, leuprolide, flutamide, or bicalutamide may stop the adrenal glands from producing androgens. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Combining hormone therapy with internal radiation may be effective in treating locally recurrent prostate cancer.

PURPOSE: Phase II trial to study the effectiveness of hormone therapy followed by internal radiation in treating patients who have locally recurrent prostate cancer following external-beam radiation therapy.


Condition Intervention Phase
Prostate Cancer
Drug: bicalutamide
Drug: flutamide
Drug: goserelin acetate
Drug: leuprolide acetate
Procedure: neoadjuvant therapy
Radiation: brachytherapy
Radiation: iodine I 125
Radiation: palladium Pd 103
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Trial Of Neoadjuvant Androgen Supression And Dose Escalation Transperineal Ultrasound-Guided Brachytherapy For Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy

Resource links provided by NLM:


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

Study Start Date: February 2002
Detailed Description:

OBJECTIVES:

  • Determine the nature, intensity, and time course of health-related quality of life changes in patients with locally recurrent prostate adenocarcinoma treated with androgen suppression and transperineal ultrasound-guided brachytherapy after external beam radiotherapy.
  • Determine the morbidity of patients treated with this regimen.
  • Determine the overall survival, disease-free survival, and disease-specific survival of patients treated with this regimen.
  • Determine the clinical patterns of tumor recurrence (i.e., time to local tumor progression or distant failure) and time to biochemical failure of patients treated with this regimen.
  • Determine the post-brachytherapy dosimetric coverage of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive androgen suppression comprising goserelin subcutaneously (as either 4 one-month depot injections or 1 one-month depot injection and 1 three-month depot injection) OR leuprolide intramuscularly (as 4 one-month depot injections or 1 one-month depot injection and 1 three-month depot injection or 1 four-month depot injection) AND oral flutamide 3 times daily for 112 days OR oral bicalutamide once daily for 112 days.

Within 4 weeks after completion of androgen suppression, patients are sequentially enrolled to 2 different cohorts of brachytherapy.

  • Cohort 1: Patients undergo initial-dose transperineal interstitial permanent prostate brachytherapy with iodine I 125 or palladium Pd 103.
  • Cohort 2: After a minimum of 1-year follow-up for all patients in cohort 1, if tolerance is acceptable, additional patients undergo higher-dose transperineal interstitial permanent prostate brachytherapy with iodine I 125 or palladium Pd 103.

Quality of life is assessed at baseline, within 2 weeks prior to brachytherapy, every 3 months for 1 year, and then every 6 months for 2 years.

Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 83-166 patients (83 per cohort) will be accrued for this study within 1.5-3 years.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed locally recurrent or persistent prostate adenocarcinoma

    • Locally recurrent disease
    • Prostate-specific antigen (PSA) no greater than 10 ng/mL
    • N0 and M0 (at time of initial diagnosis and at time of local recurrence)

      • Lymph nodes must be negative or will be negative after nodal sampling or dissection
  • More than 18 months after completion of prior external beam radiotherapy
  • Must have had 1 of the following disease characteristics prior to external beam radiotherapy:

    • T1-2a, Gleason score 2-6, and PSA no greater than 15 ng/mL
    • T1-2a, Gleason score 7, and PSA no greater than 4 ng/mL
    • T2b, Gleason score 2-6, and PSA no greater than 6 ng/mL
  • Must have American Urological Association Symptom Index score no greater than 15
  • Transrectal ultrasound-determined prostate planimetry volume no greater than 60 mL
  • No pubic arch interference of more than 1/3 the prostatic volume determined by transrectal ultrasound or pelvic CT scan

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0-1 OR
  • ECOG 0-1

Life expectancy:

  • At least 5 years

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No persistent late intestinal or bladder toxicity grade 2 or greater
  • No other major medical or psychiatric illness that would preclude study
  • No metallic hip prosthesis
  • No other malignancy within the past 5 years except localized basal cell or squamous cell skin cancer
  • No other concurrent illness that would limit life expectancy
  • Suitable for spinal or general anesthesia
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy for prostate cancer

Endocrine therapy:

  • At least 12 months since prior androgen suppression except goserelin or leuprolide with flutamide or bicalutamide begun within the past 30 days

Radiotherapy:

  • See Disease Characteristics
  • No prior external beam radiotherapy doses exceeding 71 Gy to the prostate
  • No prior radionuclide prostate brachytherapy

Surgery:

  • No prior transurethral prostate resection
  • No prior prostatectomy or prostatic cryosurgery
  • No prior bilateral orchiectomy

Other:

  • No concurrent participation in another medical research study for prostate cancer treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00032006

Locations
United States, Arizona
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Illinois
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Iowa
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212-4772
United States, Wisconsin
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54301
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Thomas M. Pisansky, MD Mayo Clinic
Investigator: Robert M. Arusell, MD Roger Maris Cancer Center at MeritCare Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00032006     History of Changes
Other Study ID Numbers: CDR0000069248, NCCTG-N0052
Study First Received: March 8, 2002
Last Updated: February 18, 2011
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Flutamide
Leuprolide
Goserelin
Bicalutamide
Iodine
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Fertility Agents, Female

ClinicalTrials.gov processed this record on April 21, 2014