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No accrual interest
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This study involves Stereotactic Body Radiation Therapy (SBRT) followed by prostatectomy (removal of the prostate). SBRT is a relatively new radiation technique in which a few doses of radiation are delivered to small, well-defined tumors. It has been used effectively in other cancers like lung and liver. The radiation will be given for only 5 days.
The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given before prostatectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Body Radiation Therapy, followed by Prostatectomy | Experimental | Patients will receive 6 Gy per day of Stereotactic Body Radiation Therapy (SBRT) per day for 5 days, followed by prostatectomy in 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Device | SBRT treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure of PSA (Prostate Specific Antigen) | Measure of PSA through treatment. PSA is expected to be undetectable (<0.2 mg/ml) after prostatectomy and radiation therapy. | Up to 12 months |
| Number of symptomatic adverse anastomotic events | Number of symptomatic anastomotic events related to pre-operative SBRT. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Catheterization Time | Average time of catheterization following prostatectomy | Up to 4 weeks post surgery |
| Mean Hospital Stay | Average time of hospitalization after prostatectomy |
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| Name | Affiliation | Role |
|---|---|---|
| Peter Johnstone, MD | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| Up to 2 week post surgery |
| Quality of Life assessment | Quality of Life will be assessed using 2 questionnaires: International Prostate Symptom Score (IPSS) and Sexual Health Inventory for Men (SHIM). The IPSS is an eight question questionnaire of symptoms ranging from 0 "not at all" to 5 "always". The SHIM is a five question questionnaire ranging from 1 "almost never or never" to 5 "almost always or always" to determine erectile dysfunction. | Baseline, at 2 weeks, 4 weeks, 2 months and every 3 months up to 12 months post surgery |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |