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View Clinical Trial (Medical Research Study)
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Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer - NCT00063882-54601B (Clinical Trial 116700)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy116700.aspx
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| City: |
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La Crosse |
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State:
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WI |
| Zip Code: |
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54601 |
| Conditions: |
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Prostate Cancer |
| Purpose: |
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RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor
cells. Interstitial brachytherapy uses radioactive material placed directly into or near a
tumor to kill tumor cells. Combining interstitial brachytherapy with external-beam radiation
therapy may kill more tumor cells. It is not yet known whether interstitial brachytherapy is
more effective with or without external-beam radiation therapy in treating prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of interstitial
brachytherapy with or without external-beam radiation therapy in treating patients who have
prostate cancer.
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| Study summary: |
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OBJECTIVES:
- Compare the 5-year freedom from progression in patients with intermediate-risk prostate
cancer treated with interstitial brachytherapy with or without external beam
radiotherapy (EBRT).
- Compare biochemical (i.e., prostate-specific antigen) failure, biochemical failure by
the Phoenix definition, disease-specific survival, local progression, and distant
metastases in patients treated with these regimens.
- Compare morbidity and quality of life of patients treated with these regimens.
- Determine the feasibility of collecting Medicare data in a large RTOG prostate cancer
clinical trial for cost effectiveness and cost utility analysis of combined treatment
with interstitial brachytherapy and EBRT.
- Prospectively collect diagnostic biopsy samples from these patients for future
biomarker analyses.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease stage (T1c vs T2a or T2b), Gleason score (≤ 6 vs 7), prostate-specific antigen (< 10
ng/mL vs 10-20 ng/mL), and prior neoadjuvant hormonal therapy (yes vs no). Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo external beam radiotherapy 5 days a week for 5 weeks. Within
2-4 weeks of radiotherapy, patients undergo interstitial brachytherapy with iodine I
125 or palladium Pd 103 seeds.
- Arm II: Patients undergo interstitial brachytherapy only, as in arm I. Quality of life
is assessed at baseline, at 4, 12, and 24 months, and then annually for 3 years.
After completion of study treatment, patients are followed at 3-5 weeks, at 4, 6, 9, and 12
months, every 6 months for 4 years, and then annually thereafter. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- T1c-T2b, N0, M0
- Intermediate-risk disease, as defined by 1 of the following:
- Gleason score < 7 AND prostate-specific antigen (PSA) 10-20 ng/mL
- Gleason score 7 AND PSA < 10 ng/mL
- No evidence of distant metastases
- Prostate volume ≤ 60 cc by transrectal ultrasonography
- American Urological Association voiding symptom score no greater than 15 (alpha
blockers allowed)
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Patients must use effective contraception
- No other malignancy within the past 5 years except basal cell or squamous cell skin
cancer or carcinoma in situ at any other site
- No major medical or psychiatric illness that would preclude study therapy
- No hip prosthesis
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- Prior neoadjuvant hormonal therapy allowed provided the following are true:
- Therapy was initiated within 2-6 months of study enrollment
- Therapy was no more than 6 months in duration
- Use of 5-alpha reductase inhibitors (e.g., finasteride) is discontinued before
registration
- No concurrent hormonal therapy
Radiotherapy
- No prior pelvic radiotherapy
Surgery
- No prior radical surgery for prostate cancer
- No prior transurethral resection of the prostate
- No prior cryosurgery
Other
- No prior transurethral needle ablation of the prostate
- No prior transurethral microwave thermotherapy of the prostate |
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| Study is available at: |
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Franciscan Skemp Healthcare - La Crosse Campus
La Crosse, WI 54601
United States
Primary Contact:
Kernan J. Minehan, MD
Phone: 608-791-9510 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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