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Objective:
To focus the high dose radiation to the gross tumor in the prostate while maintaining adequate dose for control of microscopic disease elsewhere in the prostate.
In order to test the incorporation of the robust MRI and TRUS fusion algorithm in the clinical setting the investigators planned a study of Focused therapy with a primary endpoint of accurate localization of the high risk region. This is a pilot study of dose painted permanent I-125 seed implant to verify absence of tumor cells outside a high risk region using multi-parametric MRI and deformable TRUS registration. The high risk region will be dose painted to 160 Gy and the rest of the prostate will receive the normal prescription dose.
Primary end-point:
Feasibility of dose painting will be determined by the absence of tumor outside the high-risk region on an intra-operative trans-perineal biopsy.
Frozen sections will not be obtained, however on receipt of the final pathology 2-4 weeks after the procedure 2 possible scenarios arise:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brachytherapy | men eligible for monotherapy seed implant brachytherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brachytherapy | Procedure | Biopsies will be obtained after intraoperative plan to rule out significant cancer outside a high risk planning target volume |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with a positive biopsy outside the defined High risk Planning Target Volume | Negative biopsy outside the high risk planning target volume will confirm the accuracy of the MRI TRUS elastic fusion algorithm to locate the tumor | Pathological report due one month after brachytherapy implant |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical failure as determined by Prostate specific antigen greater than nadir+2 ng/ml | 3 years | |
| Urinary , Sexual ,Bowel and Vitality function domains | Expanded Prostate Inventory Composite (EPIC) |
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Inclusion Criteria:
Men suitable for monotherapy with permanent Iodine 125 implant
Exclusion Criteria:
Have anesthesia surgical assignment category IV or greater
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men eligible for prostate brachytherapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zvi Symon, MD | Contact | 97235308175 | symonz@sheba.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Zvi Symon, MD | Chaim Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba_Medical_Center | Tel Litwinsky | 5262160 | Israel |
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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 |
|---|---|
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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Biopsies will be obtained using a transperineal approach
| 6 months and then at years one , two and three |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |