Study Results
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View full resultsBasic Information
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COMPLETED
NA
1 participants
INTERVENTIONAL
2023-11-10
2025-08-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (TMA, radical prostatectomy)
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.
Microwave Ablation
Undergo transperineal MRI/US fusion guided transperineal targeted microwave ablation
Multiparametric Magnetic Resonance Imaging
Undergo planning mpMRI of prostate
Questionnaire Administration
Ancillary studies
Radical Prostatectomy
Undergo RP
Biospecimen Collection
Undergo blood sample collection
Interventions
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Microwave Ablation
Undergo transperineal MRI/US fusion guided transperineal targeted microwave ablation
Multiparametric Magnetic Resonance Imaging
Undergo planning mpMRI of prostate
Questionnaire Administration
Ancillary studies
Radical Prostatectomy
Undergo RP
Biospecimen Collection
Undergo blood sample collection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 radiotherapy or pelvic trauma
* Past treatment for prostate cancer (PCa) (radiation, ablation, androgen deprivation therapy \[ADT\], chemotherapy)
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Andre Luis Abreu, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2023-02517
Identifier Type: REGISTRY
Identifier Source: secondary_id
4P-23-1
Identifier Type: OTHER
Identifier Source: secondary_id
4P-23-1
Identifier Type: -
Identifier Source: org_study_id
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