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

Sponsor:	Radiation Therapy Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00006365

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 II

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:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Cadexomer iodine Iodine

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 WR, DeSilvio M, Lawton C, Gillin M, Morton G, Firat S, Baikadi M, Kuettel M, Greven K, Sandler H. A phase II study of external beam radiotherapy combined with permanent source brachytherapy for intermediate-risk, clinically localized adenocarcinoma of the prostate: preliminary results of RTOG P-0019. Int J Radiat Oncol Biol Phys. 2006 Mar 1;64(3):804-9. Epub 2005 Nov 14.

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, Bae K, Lawton CA, Gillin MT, Morton G, Firat S, Baikadi M, Kuettel M, Greven K, Sandler H. A descriptive analysis of postimplant dosimetric parameters from Radiation Therapy Oncology Group P0019. Brachytherapy. 2006 Oct-Dec;5(4):239-43.

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.

Lee WR, Bae K, Lawton C, Gillin M, Morton G, Firat S, Baikadi M, Kuettel M, Greven K, Sandler H. Late toxicity and biochemical recurrence after external-beam radiotherapy combined with permanent-source prostate brachytherapy: analysis of Radiation Therapy Oncology Group study 0019. Cancer. 2007 Mar 5; [Epub ahead of print]

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 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

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 February 12, 2012