Prostate Resection After Microwave Ablation (PRAMA)

University of Southern California

Status: Completed

Conditions: Prostate Carcinoma

Treatments: Device: Multiparametric Magnetic Resonance Imaging; Device: Microwave Ablation; Other: Questionnaire Administration; Procedure: Radical Prostatectomy; Procedure: Biospecimen Collection

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06128525

4P-23-1 (Other Identifier)

NCI-2023-02517 (Registry Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Treatment (TMA, radical prostatectomy)

Experimental group

Description:

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.

Treatment:

Procedure: Biospecimen Collection

Procedure: Radical Prostatectomy

Other: Questionnaire Administration

Device: Microwave Ablation

Device: Multiparametric Magnetic Resonance Imaging