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The specific objective of this study is to compare the relative efficacy of the combination of a temporary iridium implant plus external beam irradiation versus standard external beam irradiation alone in patients with Stage B2 and C prostatic carcinoma. Benefit will be assessed in terms of local recurrence, survival, and toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Iridium implant plus external beam irradiation |
|
| 2 | Active Comparator | Standard external beam irradiation alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iridium Implant | Procedure | Temporary iridium implant of the prostate will be done and a dose of 3000 cGy will be delivered in the next 48-72 hours. Two weeks later 20 fractions of external beam radiation at a dose of 4000 cGy will be administered over a period of 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of local control as determined by biopsy at 18 months | 18-months |
| Measure | Description | Time Frame |
|---|---|---|
| Distant metastasis | survival | |
| Overall mortality | survival | |
| Mortality due to prostate cancer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinka Sathya, MD | Juravinski Cancer Centre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Juravinski Cancer Centre | Hamilton | Ontario | L8V 5C2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15718316 | Background | Sathya JR, Davis IR, Julian JA, Guo Q, Daya D, Dayes IS, Lukka HR, Levine M. Randomized trial comparing iridium implant plus external-beam radiation therapy with external-beam radiation therapy alone in node-negative locally advanced cancer of the prostate. J Clin Oncol. 2005 Feb 20;23(6):1192-9. doi: 10.1200/JCO.2005.06.154. |
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| Standard external beam irradiation | Radiation | Standard external beam irradiation at a dose of 6400 cGy in 32 fractions over 6 and a half weeks will be administered. |
|
| survival |
| Local complications of radiation | 2-5 years |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D007495 | Iridium |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
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