Clinical trial · Interventional
Ablation of Prostate Tissue Utilizing Sterile Water Vapor in Patients With Intermediate Risk Localized Prostate Cancer
Multicenter Pilot Study of the Poseidon System for the Ablation of Prostate Tissue Utilizing Sterile Water Vapor in Patients With Intermediate Risk Localized Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this research study is to collect information on a new treatment of prostate tissue participants with intermediate risk prostate cancer using a medical device called the Poseidon System. The Poseidon System is intended to ablate prostate tissue in areas of the prostate where cancer has been identified. The medical device delivers thermal energy in the form of water vapor to the prostate tissue through the urethra. Previous research has shown successful prostate tissue ablation. Additional research may help show successful ablation of the prostate tissue where cancer is located.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Poseidon System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Poseidon System Treatment
- interventionNames
- Device: Poseidon System
Primary outcomes (1)
- measure
- Serious device related adverse events
- timeFrame
- 180-day follow-up
Secondary outcomes (11)
- measure
- Adverse events, serious and non-serious, related and unrelated, will be collected on all patients enrolled
- timeFrame
- Up to 1 Years
- measure
- Changes from baseline in the Expanded Prostate Cancer Index Questionnaire (EPIC)
- timeFrame
- 180-day follow-up
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 45-80 years old * Biopsy confirmed unilateral, adenocarcinoma of the prostate * Minimum of 12 biopsy cores obtained ≥4 weeks and ≤12 months before treatment. Targeted fusion biopsy is preferred if there is a MRI PI-RADs ≥3 lesion. It is preferred a standard 12 sector biopsy is mapped. MRI required if biopsy was completed \>6 months prior to treatment date to confirm no MRI progression of disease that would be considered exclusionary. * ≤4 of 6 standard sector biopsy cores positive for prostate cancer (unilateral); positive core(s) from a targeted lesion count as one positive core. * Gleason score of 7 (3+4) / International Society of Urological Pathologists (ISUP) Gleason Grade Group (GGG) 2 * Clinical Stage less than or equal to T2b N0 M0 * PSA (Prostate Specific Antigen) less than or equal to 15ng/mL * Prostate size 20-80cc Exclusion Criteria: * Malignant tumors identified by extraprostatic extension, sphincter involvement/lesion abutment seminal vesicle invasion or lymph node invasion or metastasis * Narrow Peripheral Zone * MRI identified PI-RADs ≥4 lesion contralateral to the side that has biopsy confirmed adenocarcinoma * Prior definitive treatment of prostate cancer
References
Publications (0)
Data not yet available