Clinical trial · Observational
Deformable Registration of Multi-parametric MRI to Intra-operative Transrectal Ultrasound for Prostate Brachytherapy
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brachytherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Brachytherapy
- description
- men eligible for monotherapy seed implant brachytherapy
- interventionNames
- Procedure: Brachytherapy
Primary outcomes (1)
- measure
- Percentage of patients with a positive biopsy outside the defined High risk Planning Target Volume
- timeFrame
- Pathological report due one month after brachytherapy implant
- description
- Negative biopsy outside the high risk planning target volume will confirm the accuracy of the MRI TRUS elastic fusion algorithm to locate the tumor
Secondary outcomes (2)
- measure
- Biochemical failure as determined by Prostate specific antigen greater than nadir+2 ng/ml
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Men suitable for monotherapy with permanent Iodine 125 implant * Age \> 50 yrs * PS 0-2 (WHO) * Histologic diagnosis of prostate adenocarcinoma made on transrectal guided prostate biopsy with no fewer than 12 cores taken * No more than 50% of cores involved (summary) * MRI of Prostate with Diffusion Weighted Imaging and Dynamic Contrast Enhancement with demonstrable lesion compatible with biopsy result * Gleason sum no greater than 3+4 =7 in any core * Clinical T stage no higher than T T (tumor) 2A * Prostate volume ≤60 cc * Serum prostate-specific antigen (PSA) no higher than 15 ng/mL * No prior history of malignancy except non-melanoma skin cancer * Must be suitable for general or spinal anesthesia Exclusion Criteria: Have anesthesia surgical assignment category IV or greater * Cannot cease anti-coagulant therapy * Had a malignancy, other than prostate or skin cancer (except malignant melanoma), within 5 years * urethral stricture * Prior prostate cancer therapies
References
Publications (0)
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