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External-Beam Radiation Therapy Plus Implanted Radiation Therapy in Treating Patients With Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006365
First received: October 4, 2000
Last updated: February 24, 2012
Last verified: February 2012
History of Changes
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells.

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


Condition Intervention Phase
Prostate Cancer
 Radiation: brachytherapy
Radiation: iodine I 125
Radiation: radiation therapy
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study of External Beam Radiation Therapy Combined With Permanent Source Brachytherapy for Intermediate Risk Clinically Localized Adenocarcinoma of the Prostate

Resource links provided by NLM:

Drug Information available for: Iodine Iodide
U.S. FDA Resources

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

Study Start Date: November 2000
Detailed Description:

OBJECTIVES: I. Determine the acute and late grade 3-5 genitourinary and gastrointestinal toxic effects of external beam radiotherapy followed by permanent source brachytherapy using interstitial iodine I 125 seeds in patients with intermediate risk, clinically localized adenocarcinoma of the prostate. II. Determine the freedom from PSA failure, overall survival, disease specific survival, and local and/or distant clinical relapse rates in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients undergo external beam radiotherapy (EBRT) to the pelvis 5 days a week for 5 weeks. Permanent source brachytherapy comprised of ultrasound-guided implantation of iodine I 125 seeds into the prostate is performed 2-6 weeks after completion of EBRT. Patients are followed at 1, 3, 6, 9, and 12 months, then every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study within 1 year.

  Eligibility

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

DISEASE CHARACTERISTICS: Histologically proven locally confined adenocarcinoma of the prostate Clinical stage T1c-T2b, NX or N0, M0 Gleason score 2-6 AND PSA greater than 10 ng/dL but no greater than 20 ng/dL OR Gleason score 7 AND PSA no greater than 20 ng/dL Prostate volume no greater than 60 mL by transrectal ultrasound prior to external beam radiotherapy American Urologic Association voiding symptoms score no greater than 18 No distant metastases

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Zubrod 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No hip prosthesis No other malignancy within the past 5 years except basal cell or squamous cell skin cancer No major medical or psychiatric illness that would preclude study Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Prior induction hormonal therapy allowed only if started no more than 6 months prior to study Radiotherapy: See Disease Characteristics No prior radiotherapy to pelvis Surgery: No prior transurethral resection of prostate No radical surgery for carcinoma of the prostate

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006365

  Show 254 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: W. Robert Lee, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Lee W, Bae K, Lawton C, et al.: Biochemical recurrence and late toxicity following external beam radiotherapy combined with permanent source prostate brachytherapy: analysis of RTOG 0019. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-100, S57, 2006.
Lee W, Bae K, Lawton CF, et al.: A descriptive analysis of postimplant dosimetric parameters from RTOG P0019. [Abstract] 2006 Prostate Cancer Symposium, February 24-26, 2006, San Francisco, CA. A-83, 2006.
Lee W, DeSilvio M, Lawton C, et al.: Is postimplant dosimetry associated with late morbidity? A secondary analysis of RTOG P-0019. [Abstract] American Society of Clinical Oncology 2005 Prostate Cancer Symposium, 17-19 February 2005, Orlando, Florida. A-96, 2005.
Lee WR, Desilvio M, Lawton CF, et al.: A phase II study of external beam radiation therapy combined with permanent source brachytherapy for intermediate risk clinically localized adenocarcinoma of the prostate: preliminary results of RTOG P-0019. [Abstract] J Clin Oncol 22 (Suppl 14): A-4568, 398s, 2004.

ClinicalTrials.gov Identifier: NCT00006365     History of Changes
Other Study ID Numbers: CDR0000068238, RTOG-P-0019, RTOG-DEV-1064
Study First Received: October 4, 2000
Last Updated: February 24, 2012
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

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
Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013