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| Sponsors and Collaborators: |
Radiation Therapy Oncology Group 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 |
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Prostate Cancer |
Drug: iodine I 125 Procedure: brachytherapy Procedure: radiation therapy |
Phase II |
| MedlinePlus related topics: | Cancer Prostate Cancer |
| Drug Information available for: | Iodine Cadexomer iodine |
| Study Type: | Interventional |
| Study Design: | 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 |
| Study Start Date: | November 2000 |
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 |
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 |
Show 254 Study Locations |
| Radiation Therapy Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | W. Robert Lee, MD | Wake Forest University |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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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.
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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.
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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.
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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.
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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.
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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.
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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]
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| Study ID Numbers: | CDR0000068238, RTOG-P-0019, RTOG-DEV-1064 |
| First Received: | October 4, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006365 |
| Health Authority: | United States: Federal Government |
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