Clinical trial · Interventional
Fiducial Localization and Individualized Radiotherapy -Prostate Cancer
Fiducial Localization and Individualized Radiotherapy in Prostate Cancer (FLIP)
- 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)
This purpose of this study is designed to compare two types of images; magnetic resonance imaging (MRI) and Trans-Rectal Ultrasound (TRUS) to see which one performs more accurately for the image-guided insertion of Fiducial Markers(FMs) within the tumour. Though effective for guiding FM placement at the poles of the prostate gland due to excellent visualization of the prostatic boundaries, TRUS may not be ideally suited for marking the GTV. Conventional TRUS is neither sufficiently sensitive nor specific for accurate visualization of intra-prostatic tumor. A new interventional MRI technique enables needle guidance to the gross tumour Volume (GTV) for FM placement. It is of particular importance that both techniques be evaluated to enable which one is more effective so that it can be implemented in the designs of future trials involving dose-escalation to prostate.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transrectal APT Device or Transperineal Device will be used | Device | — | UNRESOLVED |
| TRUS probe | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- MRI-guided FM
- interventionNames
- Device: Transrectal APT Device or Transperineal Device will be used
- type
- ACTIVE_COMPARATOR
- label
- TRUS-guided FM
- interventionNames
- Device: TRUS probe
Primary outcomes (1)
- measure
- To compare the performance of MRI and TRUS images in guiding the insertion of a fiducial marker within the Gross Target Volume (GTV)
- timeFrame
- 5 years
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. ≥ 18 years old 2. ECOG status ≤ 1 3. High risk localized cancer planned for RT under FM guidance 4. Gleason \> 7, PSA \> 20, Clinical stage ≥ T3 5. patients(pts) must give written informed consent Exclusion Criteria: 1. pts \> 136 kg or \> 60 cm in girth 2. Pts with pacemakers, cerebral aneurysm clips, shrapnel injury or devices not compatible with MRI. 3. pts with severe claustrophobia 4. pts with bleeding diathesis and anticoagulative therapy that cannot be ceased prior to needle procedures. 5. Contraindications to endorectal probe, surgically absent rectum, severe hemorrhoids or previous colorectal surgery. 6. Latex Allergy
References
Publications (0)
Data not yet available