Prostate Cancer
Conditions
Keywords
Water Vapor, Ablation, Prostate Cancer, Vapor Ablation
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.
Interventions
DEVICEWater Vapor Ablation
Water vapor ablation delivered transurethrally in patients undergoing a radical prostatectomy for prostate cancer.
Sponsors
Francis Medical Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lesion Characterization by Location and Thermal Damage | Evaluated immediately post procedure. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adequacy Scale to Measure Visualization During Procedure | From the beginning to the end of the treatment procedure. | Visualization during the procedure is important to ensure proper placement of the needle. Ultrasound was evaluated for visualization and graded by operator. Visualization adequacy was assessed in real time by the physician using a categorical scale (adequate/somewhat adequate/inadequate), based on subjective evaluation of target and instrument visibility on the ultrasound image. |
| Safety Measurements | Through 30 days following procedure. | Any procedure-related AEs were collected and reported through 30 days. |
Countries
Panama
Outcome results
None listed