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Trial Title:
Prostate Resection After Microwave Ablation (PRAMA)
NCT ID:
NCT06128525
Condition:
Prostate Carcinoma
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Treatment (TMA, radical prostatectomy)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Device
Intervention name:
Microwave Ablation
Description:
Undergo transperineal MRI/US fusion guided transperineal targeted microwave ablation
Arm group label:
Treatment (TMA, radical prostatectomy)
Other name:
Ablation, Microwave
Intervention type:
Device
Intervention name:
Multiparametric Magnetic Resonance Imaging
Description:
Undergo planning mpMRI of prostate
Arm group label:
Treatment (TMA, radical prostatectomy)
Other name:
MP-MRI
Other name:
mpMRI
Other name:
Multi-parametric MRI
Other name:
Multiparametric MRI
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Treatment (TMA, radical prostatectomy)
Intervention type:
Procedure
Intervention name:
Radical Prostatectomy
Description:
Undergo RP
Arm group label:
Treatment (TMA, radical prostatectomy)
Other name:
Prostatovesiculectomy
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.
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 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.
Criteria for eligibility:
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)
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
USC / Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Andre Luis Abreu
Phone:
323-865-3000
Email:
andre.abreu@med.usc.edu
Investigator:
Last name:
Andre Luis Abreu
Email:
Principal Investigator
Start date:
November 10, 2023
Completion date:
November 10, 2025
Lead sponsor:
Agency:
University of Southern California
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Southern California
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06128525
