Status:
COMPLETED
Prostate Resection After Microwave Ablation (PRAMA)
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Carcinoma
Eligibility:
MALE
18+ years
Phase:
NA
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 ...
Detailed 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 OBJ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2025
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT06128525
Start Date
November 10 2023
End Date
August 27 2025
Last Update
November 28 2025
Active Locations (1)
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1
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033