N/A
N=1
Prostate Resection After Microwave Ablation (PRAMA)
Prostate Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT06128525 ↗Enrolled (actual)
1
Serious AEs
—
Results posted
Nov 2025
Primary outcome: Primary: The Area of the Transperineal Targeted Microwave Ablation (TMA) Induced Tissue Death Assessed by Triphenyltetrazolium Chloride (TTC) Staining
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Biospecimen Collection (Procedure); Microwave Ablation (Device); Multiparametric Magnetic Resonance Imaging (Device); Questionnaire Administration (Other); Radical Prostatectomy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Southern California
- Primary completion
- Aug 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Area of the Transperineal Targeted Microwave Ablation (TMA) Induced Tissue Death Assessed by Triphenyltetrazolium Chloride (TTC) Staining |
— | — |
| SECONDARY Incidence of Adverse Events |
— | — |
| SECONDARY Duration of Targeted Microwave Ablation (TMA) Procedure |
— | — |
| SECONDARY Number of Microwave Ablations Needed to Ablate One Multiparametric Magnetic Resonance Imaging (mpMRI)-Visible Lesion |
— | — |
| SECONDARY The Area of the Transperineal Targeted Microwave Ablation (TMA) Induced Tissue Death Assessed by Hematoxylin and Eosin (H&E) Staining. |
— | — |
| SECONDARY Difference Between the Ablation Location in the Prostate as Seen in the KOELIS 3-dimensional Map and the Ablation Location Observed Histologically on the Prostatectomy Specimen |
— | — |
| SECONDARY Change in Urinary Functions Assessed by International Prostate Symptoms Score and Uroflowmetry |
— | — |
| SECONDARY Change in Erectile Functions Assessed by International Index of Erectile Function-5 Score |
— | — |
| SECONDARY Change in Quality of Life Assessed by Expanded Prostate Cancer Index Composite-26 Short Form |
— | — |
| SECONDARY Difference Between the Treatment Effect Dimensions Measured Histologically on the Prostatectomy Specimen Resected After TMA, Compared to the Predictive Ablation Charts Provided by the Manufacturer |
— | — |
| SECONDARY Difference Between the Treatment Effect Dimensions Measured Histologically on the Prostatectomy Specimen Resected One Month After TMA, Compared to Post TMA Dimensions Measured on the Pre-RP mpMRI |
— | — |
Summary
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT06128525). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.