Water Vapor Ablation For Localized Intermediate Risk Prostate Cancer

Overview

About this study

The purpose of this study is to evaluate the safety and effectiveness of the Vanquish Water Vapor Ablation Device ("Vanquish") in treating subjects with Gleason Grade Group 2 (GGG2) localized intermediate-risk prostate cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. ≥50 years of age; with life expectancy of ≥10 years

2. 20-80 cc prostate size measured by MRI

3. ≤15 ng/ml PSA

4. Cancer stage less than or equal to T2c

5. Within 6 months of signing consent, have undergone a multiparametric MRI software
guided fusion biopsy of the prostate (transrectal or transperineal). This must include
a standard sector biopsy obtaining 12-16 cores.

6. ≤15mm diameter of lesion as measure by greatest diameter

7. Subject is willing and able to adhere to specific protocol visits and required testing
throughout study

8. Is geographically stable and near the site or able and willing to travel back to site
for follow-up visits involving diagnostic tests or treatment

9. Able and willing to provide written consent to participate in the study.

Exclusion Criteria:

1. MRI evidence of extracapsular extension of cancer (MRI read as "definite", "frank" or
"gross" ECE)

2. Contraindications to MRI

3. Subjects with an installed pacemaker or other potentially electrically conductive
implants implanted within 200mm (8 inches) of the procedure area. Implants that are
within 200mm (8 inches) and can be turned off for the duration of the study procedure
are acceptable.

4. Any prior surgery, intervention, or minimally invasive therapy, (MIST) for the
prostate cancer or bladder neck.

5. Previous treatment for genital cancer

6. Presence of any urethral or prostatic condition that precludes water vapor ablation
per Instructions for Use

7. Currently taking medications that have hormonal effects on the prostate or PSA, such
as: 5 alpha reductase inhibitors (if on for <6 months), Androgen blockers, Luteinizing
hormone-releasing hormone (LHRH) agonists or antagonists (12 month wash-out), or
Testosterone supplementation

8. Active urinary tract infection

9. Active or clinically chronic prostatitis or granulomatous prostatitis

10. Active lower and upper urinary tract malignancy (excluding prostate cancer meeting the
inclusion criteria)

11. Any rectal pathology, anomaly or previous treatment that could change properties of
rectal wall or insertion and use of TRUS

12. Unable to stop taking antiplatelet medications or other blood thinning agents

13. Known allergy to nickel

14. Allergic to medication required by the study such as MRI contrast or anesthesia

15. Any significant medical history that would pose an unreasonable risk or make the
subject unsuitable for the study

16. Any cognitive or psychiatric condition that interferes with or precludes direct and
accurate communication with the study Investigator regarding the study or affects the
ability to complete the study quality of life questionnaires

17. Subject currently participating in other premarket investigational studies unless
approved by Sponsor in writing

18. Subject is considered vulnerable such as incarcerated or cognitively impaired.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 2//2203. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Derek Lomas, M.D.

Closed for enrollment

Contact information:

Kerry Peterson

(507) 293-0168

peterson.kerry@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Daniel Frendl, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions