Clinical trial · Interventional
Focal Ablation With Focal Cryotherapy or HIFU for the Treatment of Men With Localized Prostate Cancer
A Pragmatic Phase 2 Study of Focal Ablation (Focal Cryotherapy or High Intensity Frequency Ultrasound) in Men With Clinically Localized Prostate Cancer
NCT06178354CI-TRIAL-00116309recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This clinical trial evaluates the effectiveness of focal ablation with either focal cryotherapy or high intensity frequency ultrasound for the treatment of men with localized prostate cancer. Focal cryotherapy kills tumor cells by freezing them. High intensity frequency ultrasound uses highly focused ultrasound waves to produce heat and destroy tumor cells.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Localized Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIIA Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryosurgery | Procedure | — | UNRESOLVED |
| High-Intensity Focused Ultrasound Ablation | Procedure | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (cryosurgery, high intensity focused ultrasound)
- description
- Patients undergo focal cryotherapy or high intensity focused ultrasound on study.
- interventionNames
- Procedure: Cryosurgery
- Procedure: High-Intensity Focused Ultrasound Ablation
- Other: Survey Administration
Primary outcomes (3)
- measure
- Pathologic outcome on surveillance prostate biopsy
- timeFrame
- At year 1 and 3
- description
- Confidence intervals for the pathologic response rate will be calculated using the Wilson score method. Pathologic response rate will be analyzed by baseline clinical and molecular characteristics using univariable and multivariable logistic regression.
- measure
- Proportion of participants who go onto whole gland salvage treatment
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Ability to understand and willingness to sign an informed consent form * Clinically localized grade group 1, 2, or 3 prostate cancer and unilateral magnetic resonance imaging (MRI) visible lesion(s). Up to 3 lesions will be allowed for focal treatment * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (Karnofsky ≥ 70%) * Patients ≥ 18 years of age at time of consent * Life expectancy ≥ 5 years * Ability and stated willingness to adhere to the study visit schedule and other protocol procedures/requirements for the duration of the study Exclusion Criteria: * Nodal or distant metastases * Prior treatment for prostate cancer * Anticipated treatment with any cancer intervention, including radiation, hormonal therapy or surgery ≤ 6 months prior to focal therapy in this study * Known contraindications to general anesthesia * Uncorrectable coagulopathy * Significant active cardiac disease within the previous 6 months including: New York Heart Association (NYHA) class 4 congestive heart failure (CHF), unstable angina, or myocardial infarction * Any condition that would prohibit the understanding or rendering of informed consent * Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial
References
Publications (0)
Data not yet available
No reference posted for this study.