Clinical trial · Interventional
Prostate Resection After Microwave Ablation (PRAMA)
PRAMA (Prostate Resection After Microwave Ablation) MRI/Ultrasound Fusion Guided Transperineal Targeted Microwave Ablation for Prostate Cancer
- 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 phase I trial tests the safety of magnetic resonance imaging (MRI)/ ultrasound (US) fusion guided transperineal targeted microwave ablation (TMA) before a radical prostatectomy (RP) and how well it works in treating patients with prostate cancer. Prostate cancer is the second most common cancer in men and most will never become aggressive. Despite this, most men choose to undergo treatment which may include surgery. Removing the prostate gland and sometimes the lymph nodes (radical prostatectomy) is an invasive treatment for prostate cancer that can have a significant negative on quality of life. TMA is a less invasive procedure that uses high temperatures given through the skin between the scrotum and the rectum (transperineal). Using focused high energy and heating tumor cells to several degrees above normal body temperature may kill them without affecting the surrounding tissue. Using multiparametric (mp)MRI/US to create a 3-dimensional picture of the tumor may help in planning and preventing damage to healthy tissue. Giving MRI/US fusion guided transperineal TMA prior to radical prostatectomy may kill tumor cells, and may improve the quality of life in patients with prostate cancer.
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 Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Microwave Ablation | Device | — | UNRESOLVED |
| Multiparametric Magnetic Resonance Imaging | Device | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Radical Prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (TMA, radical prostatectomy)
- description
- Patients undergo MRI/US fusion guided transperineal targeted TMA and then undergo standard of care RP same day or at 30 days post-TMA on study. Patients may undergo planning mpMRI of prostate prior to TMA. Patients also undergo blood sample collection at screening and post RP.
- interventionNames
- Procedure: Biospecimen Collection
- Device: Microwave Ablation
- Device: Multiparametric Magnetic Resonance Imaging
- Other: Questionnaire Administration
- Procedure: Radical Prostatectomy
Primary outcomes (1)
- measure
- The Area of the Transperineal Targeted Microwave Ablation (TMA) Induced Tissue Death Assessed by Triphenyltetrazolium Chloride (TTC) Staining
- timeFrame
- At time of radical prostatectomy (RP) immediately after TMA
- description
- The excised prostate will be sliced at 4 mm intervals. Each slice will be embedded, and a pathologist will examine the slides corresponding to each slice. The pathologist will be blinded to MR and ultrasound imaging results. TTC staining is performed to determine the dead tissue induced by the TMA.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult men diagnosed with prostate cancer and undergoing prostatectomy as treatment of choice * Index lesion visible on multiparametric MRI confirmed by targeted biopsies using KOELIS Trinity (registered trademark) * Patient suitable for intravenous (IV) sedation or general anesthesia and TMA * Free, informed, and written consent, dated and signed before the enrollment and before any exam required by the trial Exclusion Criteria: * Past medical history of prostate surgery * Past medical history of radiotherapy or pelvic trauma * Past treatment for prostate cancer (PCa) (radiation, ablation, androgen deprivation therapy \[ADT\], chemotherapy)
References
Publications (0)
Data not yet available