Prostate Carcinoma
Conditions
Brief 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.
Detailed description
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.
Interventions
PROCEDUREBiospecimen Collection
Undergo blood sample collection
DEVICEMicrowave Ablation
Undergo transperineal MRI/US fusion guided transperineal targeted microwave ablation
Undergo planning mpMRI of prostate
OTHERQuestionnaire Administration
Ancillary studies
PROCEDURERadical Prostatectomy
Undergo RP
Sponsors
National Cancer Institute (NCI)
University of Southern California
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Area of the Transperineal Targeted Microwave Ablation (TMA) Induced Tissue Death Assessed by Triphenyltetrazolium Chloride (TTC) Staining | At time of radical prostatectomy (RP) immediately after TMA | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Targeted Microwave Ablation (TMA) Procedure | At completion of TMA | Measured by the probe-in/probe-out time and the ablation time. |
| Number of Microwave Ablations Needed to Ablate One Multiparametric Magnetic Resonance Imaging (mpMRI)-Visible Lesion | At time of TMA | Count of microwave ablations needed to ablate one mpMRI-visible lesion will be reported |
| The Area of the Transperineal Targeted Microwave Ablation (TMA) Induced Tissue Death Assessed by Hematoxylin and Eosin (H&E) Staining. | At time of RP, 30 days after TMA | 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. |
| 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 | Up to 1 month | 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. |
| Incidence of Adverse Events | Up to 30 days after RP | All adverse events graded according to the Clavien Dindo Classification |
| Change in Erectile Functions Assessed by International Index of Erectile Function-5 Score | At baseline and each follow up visit, up to 30 days after RP | 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). |
| Change in Quality of Life Assessed by Expanded Prostate Cancer Index Composite-26 Short Form | At baseline and each follow up visit, up to 30 days after RP | 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. |
| 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 | Day after the TMA procedure | 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. |
| 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 | At time of RP, 30 days after TMA | 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. |
| Change in Urinary Functions Assessed by International Prostate Symptoms Score and Uroflowmetry | At baseline and each follow up visit, up to 30 days after RP | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Treatment (TMA, Radical Prostatectomy) 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.
Biospecimen Collection: Undergo blood sample collection
Microwave Ablation: Undergo transperineal MRI/US fusion guided transperineal targeted microwave ablation
Multiparametric Magnetic Resonance Imaging: Undergo planning mpMRI of prostate
Questionnaire Administration: Ancillary studies
Radical Prostatectomy: Undergo RP | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Patient withdrew consent | 1 |
Baseline characteristics
| Characteristic | Treatment (TMA, Radical Prostatectomy) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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
Population: 1 subject was enrolled, but withdrew consent and never began treatment nor study procedures. There was no data collected for this patient.
Secondary
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
Population: 1 subject was enrolled, but withdrew consent and never began treatment nor study procedures. There was no data collected for this patient.
Secondary
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
Population: 1 subject was enrolled, but withdrew consent and never began treatment nor study procedures. There was no data collected for this patient.
Secondary
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
Population: 1 subject was enrolled, but withdrew consent and never began treatment nor study procedures. There was no data collected for this patient.
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
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
Population: 1 subject was enrolled, but withdrew consent and never began treatment nor study procedures. There was no data collected for this patient.
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
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
Population: 1 subject was enrolled, but withdrew consent and never began treatment nor study procedures. There was no data collected for this patient.
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
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
Population: 1 subject was enrolled, but withdrew consent and never began treatment nor study procedures. There was no data collected for this patient.
Secondary
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
Population: 1 subject was enrolled, but withdrew consent and never began treatment nor study procedures. There was no data collected for this patient.
Secondary
Incidence of Adverse Events
All adverse events graded according to the Clavien Dindo Classification
Time frame: Up to 30 days after RP
Population: 1 subject was enrolled, but withdrew consent and never began treatment nor study procedures. There was no data collected for this patient.
Secondary
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
Population: 1 subject was enrolled, but withdrew consent and never began treatment nor study procedures. There was no data collected for this patient.
Secondary
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
Population: 1 subject was enrolled, but withdrew consent and never began treatment nor study procedures. There was no data collected for this patient.