Clinical trial · Interventional
MICRO-ultrasound Guided Prostate SBRT
MICRO-ultrasound Guided Prostate SBRT (MICRO-S)
- 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 study will test whether it is safe and effective to use stereotactic body radiation therapy (SBRT)-a short, targeted form of radiation-together with a microultrasound (microUS)-guided radiation boost to the cancerous spots inside the prostate. Researchers will compare treatment plans that use microUS to plans created using the current standard method, which relies on MRI images, to determine whether microUS can successfully guide targeted radiation.
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 |
|---|---|---|---|
| ExactVu | Device | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- CT-Guided, mpMRI Assisted Whole Prostate SBRT
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy
- type
- EXPERIMENTAL
- label
- CT-Guided Prostate SBRT with Microultrasound-Guided Dominant Intraprostatic Lesion Boost
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy
- Device: ExactVu
Primary outcomes (1)
- measure
- Acute GU Toxicity Measured by Patient-Reported Outcomes in the Expanded Prostate Cancer Index (EPIC-26)
- timeFrame
- From enrollment to 3 weeks after the end of treatment
- description
- To evaluate if microUS-guided DIL boost with dose de-escalation to the remaining prostate results in superior acute GU patient-reported outcomes when compared to standard prostate SBRT, as measured by the Expanded Prostate Cancer Index (EPIC-26)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed carcinoma of the prostate (biopsy results with 12 months of enrollment) * Intermediate risk as defined by NCCN criteria * Conventional imaging (bone scan and abdominal pelvic computed tomography) is mandatory for NCCN unfavourable intermediate risk prostate cancer patients with PSA \> 10. Negative nodal, skeletal or visceral metastases within 16 weeks of enrollment (for patients requiring staging). Alternatively, patients with no signs of extra-prostatic disease on PSMA-PET scans are also candidates for this trial * ECOG performance status 0-1 * Willing to give informed consent to participate in this clinical trial * Able and willing to complete QOL questionnaires Most responsive physician definition if androgen deprivation therapy will be used (only allowed for NCCN unfavourable intermediate risk prostate cancer) Exclusion Criteria: * Estimated prostate volume \> 60cc (volume based on transrectal ultrasound) * Prior TURP * Prior prostate cancer treatment, including 5-alpha reductase inhibitor treatment * Low, high or very high-risk disease as per NCCN guidelines * Connective tissue disease or inflammatory bowel disease * Contraindication to prostate microUS * Men with double hip prostheses * Contraindication for MRI (i.e. non-compatible stent, pacemaker, prosthesis etc.) * Anticoagulation medication (if unsafe to discontinue for fiducial marker insertion) * Diagnosis of bleeding diathesis
References
Publications (0)
Data not yet available