An interventional study of Biospecimen Collection and Microwave Ablation in Prostate Carcinoma, sponsored by University of Southern California. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-28.
Sponsored by University of Southern California · Not applicable, Interventional, and Treatment
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.
PRIMARY OBJECTIVE:
I. To determine the feasibility of transperineal targeted microwave ablation of an MRI-identified index prostate cancer in patients undergoing radical prostatectomy.
SECONDARY OBJECTIVES:
I. KOELIS Trinity ability to plan and guide treatment needles and ablations in the prostate index lesion.
II. Impact of treatments on functional outcomes and quality of life. III. Predictability of Medwaves Avecure microwave ablation charts. IV. Predictability of post microwave ablation mpMRI.
OUTLINE:
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 undergo planning mpMRI of prostate prior to TMA. Patients also undergo blood sample collection at screening and post RP.
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This study's enrollment of 1 is below the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
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Exclusion Criteria:
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.
Procedure: Biospecimen Collection · Device: Microwave Ablation · Device: Multiparametric Magnetic Resonance Imaging · Other: Questionnaire Administration · Procedure: Radical Prostatectomy
Undergo blood sample collection
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo transperineal MRI/US fusion guided transperineal targeted microwave ablation
Also known as: Ablation, Microwave
Undergo planning mpMRI of prostate
Also known as: MP-MRI, mpMRI, Multi-parametric MRI, Multiparametric MRI
Ancillary studies
Undergo RP
Also known as: Prostatovesiculectomy
The Area of the Transperineal Targeted Microwave Ablation (TMA) Induced Tissue Death Assessed by Triphenyltetrazolium Chloride (TTC) Staining
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.
Time frame: At time of radical prostatectomy (RP) immediately after TMA
Incidence of Adverse Events
All adverse events graded according to the Clavien Dindo Classification
Time frame: Up to 30 days after RP
Duration of Targeted Microwave Ablation (TMA) Procedure
Measured by the probe-in/probe-out time and the ablation time.
Time frame: At completion of TMA
Number of Microwave Ablations Needed to Ablate One Multiparametric Magnetic Resonance Imaging (mpMRI)-Visible Lesion
Count of microwave ablations needed to ablate one mpMRI-visible lesion will be reported
Time frame: At time of TMA
The Area of the Transperineal Targeted Microwave Ablation (TMA) Induced Tissue Death Assessed by Hematoxylin and Eosin (H&E) Staining.
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. H\&E staining is performed to determine the dead tissue induced by the TMA.
Time frame: At time of RP, 30 days after TMA
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
The difference between the ablation location as seen in the KOELIS 3D reconstruction of the prostate ("3D Map") will be compared to the ablation location observed histologically on the prostatectomy specimen.
Time frame: Up to 1 month
Change in Urinary Functions Assessed by International Prostate Symptoms Score and Uroflowmetry
Urinary functions will be measured using International Prostate Symptoms Score (IPSS) and uroflowmetry. The IPSS can be 0-35 (higher score means worse urinary function). Uroflowmetry evaluates the maximum flow rate, average flow rate, flow time, voided volume, and the waveform of the flow rate.
Time frame: At baseline and each follow up visit, up to 30 days after RP
Change in Erectile Functions Assessed by International Index of Erectile Function-5 Score
Erectile functions will be measured using International Index of Erectile Function (IIEF)-5 score. IIEF-5 score can be 5-25 (higher score means better erectile function).
Time frame: At baseline and each follow up visit, up to 30 days after RP
Change in Quality of Life Assessed by Expanded Prostate Cancer Index Composite-26 Short Form
Quality of life (QOL) will be measured using Expanded Prostate Cancer Index Composite (EPIC)-26 Short Form score. EPIC-26 includes 13 questionnaires assessing several aspects of QOL. The interpretation of whether a higher numerical value in response to a questionnaire indicates a favorable outcome.
Time frame: At baseline and each follow up visit, up to 30 days after RP
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
The comparison of the difference between the treatment effect dimensions measured histologically on the prostatectomy specimen resected after TMA and the predictive ablation charts provided by the manufacturer will be performed.
Time frame: Day after the TMA procedure
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
The comparison 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 will be performed.
Time frame: At time of RP, 30 days after TMA
Recruitment for this study opened in November 2023 and closed in August 2025. 1 subject was enrolled in the medical clinic at the University of Southern California, but withdrew consent and never began treatment nor study procedures. There was no data collected for this patient.
| Milestone | Treatment (TMA, Radical Prostatectomy) |
|---|---|
| Started | 1 |
| Completed | 0 |
| Not completed | 1 |
| Withdrew: Patient withdrew consent | 1 |
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.
No measurements were reported for this outcome.
All adverse events graded according to the Clavien Dindo Classification
No measurements were reported for this outcome.
Measured by the probe-in/probe-out time and the ablation time.
No measurements were reported for this outcome.
Count of microwave ablations needed to ablate one mpMRI-visible lesion will be reported
No measurements were reported for this outcome.
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. H\&E staining is performed to determine the dead tissue induced by the TMA.
No measurements were reported for this outcome.
The difference between the ablation location as seen in the KOELIS 3D reconstruction of the prostate ("3D Map") will be compared to the ablation location observed histologically on the prostatectomy specimen.
No measurements were reported for this outcome.
Urinary functions will be measured using International Prostate Symptoms Score (IPSS) and uroflowmetry. The IPSS can be 0-35 (higher score means worse urinary function). Uroflowmetry evaluates the maximum flow rate, average flow rate, flow time, voided volume, and the waveform of the flow rate.
No measurements were reported for this outcome.
Erectile functions will be measured using International Index of Erectile Function (IIEF)-5 score. IIEF-5 score can be 5-25 (higher score means better erectile function).
No measurements were reported for this outcome.
Quality of life (QOL) will be measured using Expanded Prostate Cancer Index Composite (EPIC)-26 Short Form score. EPIC-26 includes 13 questionnaires assessing several aspects of QOL. The interpretation of whether a higher numerical value in response to a questionnaire indicates a favorable outcome.
No measurements were reported for this outcome.
The comparison of the difference between the treatment effect dimensions measured histologically on the prostatectomy specimen resected after TMA and the predictive ablation charts provided by the manufacturer will be performed.
No measurements were reported for this outcome.
The comparison 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 will be performed.
No measurements were reported for this outcome.
Collected over 30 days after last dose of study drug, up to 1.5 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (TMA, Radical Prostatectomy) | — | — | — |
1 subject was enrolled, but withdrew consent and never began treatment nor study procedures. There was no data collected for this patient.
| Age, Categorical(Participants) | Treatment (TMA, Radical Prostatectomy) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Treatment (TMA, Radical Prostatectomy) |
|---|---|
| Female | 0 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | Treatment (TMA, Radical Prostatectomy) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 1 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Treatment (TMA, Radical Prostatectomy) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 1 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Treatment (TMA, Radical Prostatectomy) |
|---|---|
| United States | 1 |
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