Trial Outcomes & Findings for Prostate Resection After Microwave Ablation (PRAMA) (NCT NCT06128525)
NCT ID: NCT06128525
Last Updated: 2025-11-28
Results Overview
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.
COMPLETED
NA
1 participants
At time of radical prostatectomy (RP) immediately after TMA
2025-11-28
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Patient withdrew consent
|
1
|
Baseline Characteristics
Prostate Resection After Microwave Ablation (PRAMA)
Baseline characteristics by cohort
| Measure |
Treatment (TMA, Radical Prostatectomy)
n=1 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: At time of radical prostatectomy (RP) immediately after TMAPopulation: 1 subject was enrolled, but withdrew consent and never began treatment nor study procedures. There was no data collected for this patient.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days after RPPopulation: 1 subject was enrolled, but withdrew consent and never began treatment nor study procedures. There was no data collected for this patient.
All adverse events graded according to the Clavien Dindo Classification
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At completion of TMAPopulation: 1 subject was enrolled, but withdrew consent and never began treatment nor study procedures. There was no data collected for this patient.
Measured by the probe-in/probe-out time and the ablation time.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At time of TMAPopulation: 1 subject was enrolled, but withdrew consent and never began treatment nor study procedures. There was no data collected for this patient.
Count of microwave ablations needed to ablate one mpMRI-visible lesion will be reported
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At time of RP, 30 days after TMAPopulation: 1 subject was enrolled, but withdrew consent and never began treatment nor study procedures. There was no data collected for this patient.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 monthPopulation: 1 subject was enrolled, but withdrew consent and never began treatment nor study procedures. There was no data collected for this patient.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and each follow up visit, up to 30 days after RPPopulation: 1 subject was enrolled, but withdrew consent and never began treatment nor study procedures. There was no data collected for this patient.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and each follow up visit, up to 30 days after RPPopulation: 1 subject was enrolled, but withdrew consent and never began treatment nor study procedures. There was no data collected for this patient.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and each follow up visit, up to 30 days after RPPopulation: 1 subject was enrolled, but withdrew consent and never began treatment nor study procedures. There was no data collected for this patient.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day after the TMA procedurePopulation: 1 subject was enrolled, but withdrew consent and never began treatment nor study procedures. There was no data collected for this patient.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At time of RP, 30 days after TMAPopulation: 1 subject was enrolled, but withdrew consent and never began treatment nor study procedures. There was no data collected for this patient.
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.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (TMA, Radical Prostatectomy)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place