Transurethral Periprostatectomy Treatment of Cancerous Prostate Tissue

NCT07561502 | Completed

• 1 other identifier: 3838-012
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This goal of this clinical trial is to determine if the Vanquish System can safely and effectively treat cancerous tissue in the prostate. Researchers will also determine the best treatment dose, monitor safety during and immediately after the procedure, and examine prostate tissue after surgical removal to confirm how well the treatment destroyed targeted tissue. Patients enrolled have been diagnosed with prostate cancer and will undergo treatment with the Vanquish System before their scheduled radical prostatectomy.

Conditions

Prostate Cancer

Keywords

Water Vapor; Ablation; Prostate Cancer; Vapor Ablation

Outcome Measures

Primary Outcomes (1)

• Lesion Characterization by Location and Thermal Damage

  The primary efficacy endpoint is a lesion characterization from the Peri III Study vapor treatment as evaluated by TTC stain. Immediately following treatment and surgical extirpation, the prostate was examined for any external thermal injury followed by whole mount sectioning and staining using tetrazolium chloride (TTC). The whole mount sections were photographed before and after TTC staining. The sections and photographs were examined for ablation within all anatomic regions of the prostate and the ability to ablate to different regions and zones of the prostate.

  Evaluated immediately post procedure.

Secondary Outcomes (2)

• Adequacy Scale to Measure Visualization During Procedure

  From the beginning to the end of the treatment procedure.

• Safety Measurements

  Through 30 days following procedure.

Study Arms (1)

Treatment with Vanquish System

EXPERIMENTAL

Device: Water Vapor Ablation

Interventions

Water Vapor Ablation DEVICE

Water vapor ablation delivered transurethrally in patients undergoing a radical prostatectomy for prostate cancer.

Treatment with Vanquish System

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 40 years or older
• Subjects is diagnosed with clinically localized prostate cancer (Stage I (T1c) or Stage II (T2a, T2b, T2c tumor) prostate cancer) AND scheduled for a radical prostatectomy or cystoprostatectomy due to the presence of prostate cancer
• Subject has a positive biopsy for prostate cancer with Gleason score of 8 (4+4) and below
• Subject who provides written consent to participate in the study

You may not qualify if:

• Subject with prostate biopsy performed within 42 days from date of prostatectomy.
• Subject has a known allergy to nickel.
• Subject who had previous rectal surgery (other than hemorrhoidectomy)
• Subject with known history of rectal disease.
• Subject currently participating in other premarket investigational studies.
• Subject who had a previous TURP or prostatectomy.

Sponsors & Collaborators

• Francis Medical Inc.: lead

Study Sites (1)

C&M Research S.A.

Panama City, Provincia de Panamá, 0801, Panama

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: May 1, 2026
• Study Start: November 14, 2022
• Primary Completion: August 11, 2023
• Study Completion: August 11, 2023
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

PA (1)