Prostate Resection After Microwave Ablation (PRAMA)

NCT06128525 | Completed Results DMC FDA Device

• 3 other identifiers: 4P-23-1NCI-2023-02517P30CA014089
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (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.

  At time of radical prostatectomy (RP) immediately after TMA

Secondary Outcomes (10)

• Incidence of Adverse Events

  Up to 30 days after RP

• Duration of Targeted Microwave Ablation (TMA) Procedure

  At completion of TMA

• Number of Microwave Ablations Needed to Ablate One Multiparametric Magnetic Resonance Imaging (mpMRI)-Visible Lesion

  At time of TMA

• 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

• 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

Study Arms (1)

Treatment (TMA, radical prostatectomy)

EXPERIMENTAL

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

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (TMA, radical prostatectomy)

Microwave Ablation DEVICE

Undergo transperineal MRI/US fusion guided transperineal targeted microwave ablation

Also known as: Ablation, Microwave

Treatment (TMA, radical prostatectomy)

Multiparametric Magnetic Resonance Imaging DEVICE

Undergo planning mpMRI of prostate

Also known as: MP-MRI, mpMRI, Multi-parametric MRI, Multiparametric MRI

Treatment (TMA, radical prostatectomy)

Questionnaire Administration OTHER

Ancillary studies

Treatment (TMA, radical prostatectomy)

Radical Prostatectomy PROCEDURE

Undergo RP

Also known as: Prostatovesiculectomy

Treatment (TMA, radical prostatectomy)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Specimen Handling; Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Magnetic Resonance Imaging; Tomography; Diagnostic Imaging

Results Point of Contact

• Title: Tali Homsey
• Organization: USC/Norris Comprehensive Cancer Center

tali.homsey@med.usc.edu

(323) 865-0451

Study Officials

• Andre Luis Abreu, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: November 13, 2023
• Study Start: November 10, 2023
• Primary Completion: August 26, 2025
• Study Completion: August 27, 2025
• Last Updated: November 28, 2025
• Results First Posted: November 28, 2025

Record last verified: 2025-11

Locations

US (1)