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Lack of accrual
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This study is being done to test the safety of a single high-dose of radiation therapy before radical prostatectomy (removal of the prostate). The investigators want to find out what effects, good and/or bad, the radiation will have on men undergoing prostatectomy. The investigators are especially interested in men who are at risk for having cancer cells that have spread outside the prostate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Dose Single-Fraction Image-Guided Radiotherapy | Experimental | This will assess the feasibility and safety of this approach in men at high-risk for extraprostatic prostate cancer undergoing RP. This initial trial has been designed in a manner intended to emphasize patient comfort and safety. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy | Radiation | A baseline DCE-MRI will be obtained prior to the day of radiotherapy treatment. Immediately following the delivery of radiotherapy another DCE-MRI will be performed to assess for perfusion changes in the prostate resulting from irradiation. RP will be completed within 6 weeks (+ 2 weeks) of radiation and the RP specimen will be assessed for radiation treatment effect and other pathologic parameters (including surgical margin status) by a dedicated genitourinary pathologist. Following RP, participants will follow-up with their surgeon every 3 months for one year, with visits alternating between the urologist and the radiation oncologist. After the first year follow-up will occur at 6 month intervals until the patient is 3 years out from surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the feasibility and safety of single-fraction image-guided intensity modulated radiotherapy (IG-IMRT). | Given prior to radical prostatectomy (RP) in men at high risk for extraprostatic cancer. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To analyze the changes in prostate perfusion induced by single-fraction IG-IMRT. | via dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) | 1 before radiation simulation, 1 after radiation treatment |
| To assess the long-term toxicity of intensity modulated radiotherapy (IG-IMRT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Eastham, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Given prior to radical prostatectomy (RP) with respect to urinary function, erectile function, and bowel function. |
| weeks 3, 6, 9, 12, 18, 24, 30, and 36 months after RP |
| To assess the effect of IG-IMRT on the anticipated positive margin rate at the time of RP. | 1 year |
| 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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