Clinical trial · Observational
Outcomes of Focal Ablation for Prostate Cancer
Prospective Single Institutional Study Evaluating the Outcomes for Patients Undergoing Ablative Therapies in the Management of Clinically Localized Prostate Cancer in the Primary and Salvage Setting
NCT05478694CI-TRIAL-00108613recruitingClinicalTrials.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 study will be designed to define the efficacy and safety of ablative therapies in the management of localized prostate cancer and comprehensively evaluate quality of life outcomes and oncologic control following treatment.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Ablative Therapy Group
- description
- Enrolled subjects will undergo the ablative therapy as part of their standard of care treatment
Primary outcomes (8)
- measure
- Oncologic outcomes as assessed by the rate of negative in-field biopsy at 12 months (primary setting)
- timeFrame
- 12 months post treatment
- description
- Oncologic outcomes will be assessed by the rate of negative in-field biopsy at 12 months which is defined by the Delphi consensus criterion of absence of clinically significant disease (≤ 3 mm of Gleason ≤ 6 disease in any biopsy core is insignificant)
- measure
- Oncologic outcomes as assessed by the rate of advancement to systemic therapy or radical salvage therapies (primary setting)
- timeFrame
- 3 years post treatment
- description
- Oncologic outcomes will be assessed by the rate of advancement to systemic therapy or radical salvage therapies which is defined by prostatectomy, radiation or hormone therapy.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Men with histologically confirmed prostate adenocarcinoma diagnosed on prostate biopsy * Men with histologically confirmed local recurrence of prostate cancer diagnosed on prostate biopsy and standard of care imaging excluding locoregional or metastatic disease * Age 18-90 years. * Life expectancy \> 1 year * Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: * Anatomic abnormalities that do not allow for focal ablation * Evidence of non-organ confined disease that is not feasible for ablation * Has active urinary traction infection
References
Publications (0)
Data not yet available
No reference posted for this study.