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Prostate CarcinomaNCT06128525

Prostate Resection After Microwave Ablation (PRAMA)

A study testing Biospecimen Collection, Microwave Ablation and Multiparametric Magnetic Resonance Imaging in people with Prostate Carcinoma, run by University of Southern California at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Carcinoma
What is being tested?
Biospecimen Collection, Microwave Ablation and Multiparametric Magnetic Resonance Imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
10 Nov 2023to 27 Aug 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

Other trials in United States

About this study

Official title: PRAMA (Prostate Resection After Microwave Ablation) MRI/Ultrasound Fusion Guided Transperineal Targeted Microwave Ablation for Prostate Cancer

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the feasibility of transperineal targeted microwave ablation of an MRI-identified index prostate cancer in patients undergoing radical prostatectomy.

SECONDARY OBJECTIVES:

  1. 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.

Being tested
Biospecimen Collection, Microwave Ablation, Multiparametric Magnetic Resonance Imaging, Questionnaire Administration, Radical Prostatectomy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Microwave AblationDevice

    Also called Ablation, Microwave

    Undergo transperineal MRI/US fusion guided transperineal targeted microwave ablation

  • Multiparametric Magnetic Resonance ImagingDevice

    Also called MP-MRI, mpMRI, Multi-parametric MRI, Multiparametric MRI

    Undergo planning mpMRI of prostate

  • Questionnaire AdministrationOther

    Ancillary studies

  • Radical ProstatectomyProcedure or surgery

    Also called Prostatovesiculectomy

    Undergo RP

Study groups in NCT06128525
Study groupRoleWhat they receive
Treatment (TMA, radical prostatectomy)ExperimentalPatients 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.
Receives: Procedure: Biospecimen Collection; Device: Microwave Ablation; Device: Multiparametric Magnetic Resonance Imaging; Other: Questionnaire Administration; Procedure: Radical Prostatectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At time of radical prostatectomy (RP) immediately after TMA

Secondary outcomes (10)

  1. Incidence of Adverse Events

    All adverse events graded according to the Clavien Dindo Classification

    Measured: Up to 30 days after RP

  2. Duration of Targeted Microwave Ablation (TMA) Procedure

    Measured by the probe-in/probe-out time and the ablation time.

    Measured: At completion of TMA

  3. 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

    Measured: At time of TMA

  4. 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.

    Measured: At time of RP, 30 days after TMA

  5. 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.

    Measured: Up to 1 month

  6. 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.

    Measured: At baseline and each follow up visit, up to 30 days after RP

  7. 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).

    Measured: At baseline and each follow up visit, up to 30 days after RP

  8. 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.

    Measured: At baseline and each follow up visit, up to 30 days after RP

  9. 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.

    Measured: Day after the TMA procedure

  10. 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.

    Measured: At time of RP, 30 days after TMA

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2023
  2. Study start10 Nov 2023
  3. Primary completion26 Aug 2025
  4. Study completion27 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06128525
Sponsor's protocol ID
4P-23-1
Other IDs
NCI-2023-02517, 4P-23-1, P30CA014089
Status last verified
Nov 2025
First submitted
8 Sep 2023
Last updated
28 Nov 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Biospecimen Collection, Microwave Ablation and Multiparametric Magnetic Resonance Imaging in people with Prostate Carcinoma, run by University of Southern California at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Area of the Transperineal Targeted Microwave Ablation (TMA) Induced Tissue Death Assessed by Triphenyltetrazolium Chloride (TTC) Staining (time frame: At time of radical prostatectomy (RP) immediately after TMA). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06128525.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.

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