Deformable Registration of Multi-parametric MRI to Intra-operative Transrectal Ultrasound for Prostate Brachytherapy
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|ClinicalTrials.gov Identifier: NCT02790216|
Recruitment Status : Not yet recruiting
First Posted : June 3, 2016
Last Update Posted : June 3, 2016
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.
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Procedure: Brachytherapy|
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:
- There is no evidence of cancer: this confirms the accuracy of the TRUS MRI registration.
- There is evidence of tumor on the stereotactic biopsy: In this case a regular dosimetric check (this is performed in the Standard of care procedure and is known as post-operative dosimetry) will be performed to determine whether adequate dose was delivered. If not, as the involved needle position was recorded in the treatment plan and labeled with co-ordinates, the regular possibility of accurately adding radioactive seeds is possible.
|Study Type :||Observational|
|Estimated Enrollment :||24 participants|
|Official Title:||Phase II Study of Focused Dose Painted I-125 Brachytherapy for Low to Intermediate Risk Prostate Cancer Using Deformable Registration of Multi-parametric MRI (Magnetic Resonance Imaging) to Intra-operative TRUS (Trans Rectal Ultrasound)|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2020|
men eligible for monotherapy seed implant brachytherapy
Biopsies will be obtained after intraoperative plan to rule out significant cancer outside a high risk planning target volume
- Percentage of patients with a positive biopsy outside the defined High risk Planning Target Volume [ Time Frame: Pathological report due one month after brachytherapy implant ]Negative biopsy outside the high risk planning target volume will confirm the accuracy of the MRI TRUS elastic fusion algorithm to locate the tumor
- Biochemical failure as determined by Prostate specific antigen greater than nadir+2 ng/ml [ Time Frame: 3 years ]
- Urinary , Sexual ,Bowel and Vitality function domains [ Time Frame: 6 months and then at years one , two and three ]Expanded Prostate Inventory Composite (EPIC)
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790216
|Contact: Zvi Symon, MDemail@example.com|
|Tel Hashomer, Israel, 5262160|
|Principal Investigator:||Zvi Symon, MD||Chaim Sheba Medical Center|