Microwave ablation before prostate surgery
PRAMA (Prostate Resection After Microwave Ablation) MRI/Ultrasound Fusion Guided Transperineal Targeted Microwave Ablation for Prostate Cancer
This study is testing if a new microwave treatment can safely target and destroy prostate cancer tissue before surgery, helping to protect healthy tissue and improve recovery for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Southern California Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06128525 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the safety and effectiveness of using MRI/ultrasound fusion guided transperineal targeted microwave ablation (TMA) in patients with prostate cancer prior to undergoing radical prostatectomy (RP). The study aims to determine the feasibility of this less invasive procedure to target and potentially destroy cancerous tissue while preserving surrounding healthy tissue. Participants will undergo imaging to identify the tumor and then receive TMA on the same day or within 30 days before their scheduled RP. The trial also assesses the impact of this approach on functional outcomes and quality of life.
Who should consider this trial
Good fit: Ideal candidates include adult men diagnosed with prostate cancer who are planning to undergo prostatectomy and have an index lesion visible on MRI.
Not a fit: Patients who have previously undergone prostate surgery, radiotherapy, or other treatments for prostate cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the invasiveness of treatment for prostate cancer and improve patients' quality of life.
How similar studies have performed: While this approach is innovative, similar studies using microwave ablation techniques have shown promise in other contexts, but this specific application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Los Angeles, California
- USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Andre Luis Abreu, MD — University of Southern California
- Study coordinator: Ileana Aldana
- Email: Ileana.aldana@med.usc.edu
- Phone: 323-865-0702
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.