Health TrialsbyHealthPanel

Water Vapor Ablation for Grade Group 3 Prostate Cancer

ConditionProstate Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50+
SponsorFrancis Medical Inc.

About this trial

The goal of this study is to evaluate the safety and effectiveness of the Vanquish Water Vapor Ablation System ("Vanquish") in participants with Grade Group 3 (GG3) intermediate-risk prostate cancer.

Participants will undergo therapy with the Vanquish System and complete follow up visits at 7 days, 6 weeks, 6 months, 12 months, 18 months, and 24 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant has been diagnosed with Grade Group 3 (GG3) intermediate risk prostate cancer.

≤20 ng/ml PSA.

PSA density ≤0.15

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

Disqualifiers

Participants with ≥GG4 cores anywhere in the prostate.

Participants with GG2 or GG3 cores outside the region of interest.

Contraindications per the Vanquish Instructions For Use.

Any previous treatment for prostate cancer or any prior surgery, intervention, or minimally invasive therapy (MIST) for the prostate or bladder neck, including but not limited to Vanquish therapy, TUIP, TURP, Aquablation, Green Light, Rezūm, Prostatic Urethral Lift, iTind, Prostatic Arterial Embolization, or microwave therapy.

Trial design

Design model

Single group

Treatments tested in this trial

  • Water Vapor Ablation

    Device

    Water vapor ablation delivered transurethrally in patients with Grade Group 3 (GG3) intermediate risk prostate cancer.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Vanquish System TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Ablative Efficacy 6-Months Post Ablation

Ablative efficacy after one or two ablations indicating \<GG2 cancer in the region of the prostate targeted for Vanquish therapy and evaluated at 6 months post ablation.

Time frame
6 months post procedure.
2

Rate of Serious Adverse Events Through 6-Months

Rate of serious adverse events through 6-months classified per Clavien-Dindo and assessed as related to the Vanquish procedure and/or device. Clavien-Dindo Classifications * Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment, surgical, endoscopic, or radiological interventions. * Grade II: Requires pharmacological treatment with drugs other than those allowed for Grade I complications. * Grade III: Complications requiring surgical intervention (IIIa: laparoscopic, IIIb: open). * Grade IV: Life-threatening complications (IVa: single organ failure, IVb: multi-organ failure). * Grade V: Death of a patient.

Time frame
From the start of the Vanquish procedure through 6-months post procedure.

Secondary outcomes

1

Rate of Serious Adverse Events Through 24-Months

Rate of serious adverse events through 24-months classified per Clavien-Dindo and assessed as related to the Vanquish procedure and/or device. Clavien-Dindo Classifications * Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment, surgical, endoscopic, or radiological interventions. * Grade II: Requires pharmacological treatment with drugs other than those allowed for Grade I complications. * Grade III: Complications requiring surgical intervention (IIIa: laparoscopic, IIIb: open). * Grade IV: Life-threatening complications (IVa: single organ failure, IVb: multi-organ failure). * Grade V: Death of a patient.

Time frame
From the start of the Vanquish procedure through 24-months post procedure.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Francis Medical Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: