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Trial record 1 of 1 for:    NCT06128525
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Prostate Resection After Microwave Ablation (PRAMA)

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ClinicalTrials.gov Identifier: NCT06128525
Recruitment Status : Recruiting
First Posted : November 13, 2023
Last Update Posted : December 7, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Prostate Carcinoma Procedure: Biospecimen Collection Device: Microwave Ablation Device: Multiparametric Magnetic Resonance Imaging Other: Questionnaire Administration Procedure: Radical Prostatectomy Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PRAMA (Prostate Resection After Microwave Ablation) MRI/Ultrasound Fusion Guided Transperineal Targeted Microwave Ablation for Prostate Cancer
Actual Study Start Date : November 10, 2023
Estimated Primary Completion Date : November 10, 2024
Estimated Study Completion Date : November 10, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection

Device: Microwave Ablation
Undergo transperineal MRI/US fusion guided transperineal targeted microwave ablation
Other Name: Ablation, Microwave

Device: Multiparametric Magnetic Resonance Imaging
Undergo planning mpMRI of prostate
Other Names:
  • MP-MRI
  • mpMRI
  • Multi-parametric MRI
  • Multiparametric MRI

Other: Questionnaire Administration
Ancillary studies

Procedure: Radical Prostatectomy
Undergo RP
Other Name: Prostatovesiculectomy


Outcome Measures
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Primary Outcome Measures :
  1. The area of the transperineal targeted microwave ablation (TMA) induced tissue death assessed by Triphenyltetrazolium chloride (TTC) staining [ Time Frame: At time of radical prostatectomy (RP) immediately after TMA ]
    The excised prostate will be sliced at 4 mm intervals. Each slice will be embedded, and a pathologist will examine the slides corresponding to each slice. The pathologist will be blinded to MR and ultrasound imaging results. TTC staining is performed to determine the dead tissue induced by the TMA.


Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Up to 30 days after RP ]
    All adverse events graded according to the Clavien Dindo Classification

  2. Duration of TMA procedure [ Time Frame: At completion of TMA ]
    Measured by the probe-in/probe-out time and the ablation time.

  3. Number of microwave ablations needed to ablate one multiparametric magnetic resonance imaging (mpMRI)-visible lesion [ Time Frame: At time of TMA ]
    Count of microwave ablations needed to ablate one mpMRI-visible lesion will be reported

  4. The area of the transperineal targeted microwave ablation (TMA) induced tissue death assessed by hematoxylin and eosin (H&E) staining. [ Time Frame: At time of RP, 30 days after TMA ]
    The excised prostate will be sliced at 4 mm intervals. Each slice will be embedded, and a pathologist will examine the slides corresponding to each slice. The pathologist will be blinded to MR and ultrasound imaging results. H&E staining is performed to determine the dead tissue induced by the TMA.

  5. Difference between the ablation location in the prostate as seen in the KOELIS 3-dimensional map and the ablation location observed histologically on the prostatectomy specimen [ Time Frame: Up to 1 month ]
    The difference between the ablation location as seen in the KOELIS 3D reconstruction of the prostate ("3D Map") will be compared to the ablation location observed histologically on the prostatectomy specimen.

  6. Change in urinary functions assessed by International Prostate Symptoms Score and uroflowmetry [ Time Frame: At baseline and each follow up visit, up to 30 days after RP ]
    Urinary functions will be measured using International Prostate Symptoms Score (IPSS) and uroflowmetry. The IPSS can be 0-35 (higher score means worse urinary function). Uroflowmetry evaluates the maximum flow rate, average flow rate, flow time, voided volume, and the waveform of the flow rate.

  7. Change in erectile functions assessed by International Index of Erectile Function-5 score [ Time Frame: At baseline and each follow up visit, up to 30 days after RP ]
    Erectile functions will be measured using International Index of Erectile Function (IIEF)-5 score. IIEF-5 score can be 5-25 (higher score means better erectile function).

  8. Change in quality of life assessed by Expanded Prostate Cancer Index Composite-26 Short Form [ Time Frame: At baseline and each follow up visit, up to 30 days after RP ]
    Quality of life (QOL) will be measured using Expanded Prostate Cancer Index Composite (EPIC)-26 Short Form score. EPIC-26 includes 13 questionnaires assessing several aspects of QOL. The interpretation of whether a higher numerical value in response to a questionnaire indicates a favorable outcome.

  9. Difference between the treatment effect dimensions measured histologically on the prostatectomy specimen resected after TMA, compared to the predictive ablation charts provided by the manufacturer [ Time Frame: Day after the TMA procedure ]
    The comparison of the difference between the treatment effect dimensions measured histologically on the prostatectomy specimen resected after TMA and the predictive ablation charts provided by the manufacturer will be performed.

  10. Difference between the treatment effect dimensions measured histologically on the prostatectomy specimen resected one month after TMA, compared to post TMA dimensions measured on the pre-RP mpMRI [ Time Frame: At time of RP, 30 days after TMA ]
    The comparison between the treatment effect dimensions measured histologically on the prostatectomy specimen resected one month after TMA, compared to post TMA dimensions measured on the pre-RP mpMRI will be performed.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06128525


Contacts
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Contact: Ileana Aldana 323-865-0702 Ileana.aldana@med.usc.edu

Locations
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United States, California
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Andre Luis Abreu    323-865-3000    andre.abreu@med.usc.edu   
Principal Investigator: Andre Luis Abreu         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Andre Luis Abreu, MD University of Southern California
More Information
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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT06128525    
Other Study ID Numbers: 4P-23-1
NCI-2023-02517 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
4P-23-1 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: November 13, 2023    Key Record Dates
Last Update Posted: December 7, 2023
Last Verified: December 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases