Transperineal Laser Ablation Treatment for Prostate Cancer Registry: a Retrospective and Multicenter Evaluation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Oncological control
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
Rationale: Transperineal laser ablation (TPLA) treatment for prostate cancer (PCa) is a minimal invasive focal therapy technique studied worldwide to determine its efficacy. In pilot studies it has shown to be a safe and feasible technique and it has potential to preserve continence and potency over current standard radical therapies. However, (long-term) treatment outcomes of TPLA for PCa remain largely unknown. The aim of this international retrospective registry is to collect and combine data on patients treated TPLA for PCa in order to provide data on safety, feasibility, functional and oncological outcomes.
Objective: To assess safety and feasibility of TPLA for PCa, to assess functional and oncological outcomes of TPLA for PCa and to determine baseline patient characteristics in a multicentre cohort.
Study design: This is an international, retrospective observational registry in which data is recorded of patients who have been treated with TPLA for PCa.
Study population: Male patients treated with TPLA for PCa. Main study parameters/endpoints: The primary endpoint of this registry is oncological outcomes of TPLA for PCa. Secondary endpoints are safety, feasibility and functional outcomes of TPLA for PCa.
Investigators
Prof.dr. H.P. Beerlage
Professor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Eligibility Criteria
Inclusion Criteria
- •Male, histological-confirmed disease of localized prostate cancer, TPLA treatment for PCa is performed
Exclusion Criteria
- •Age \< 18 years
Outcomes
Primary Outcomes
Oncological control
Time Frame: 12 months
Oncological control is defined as: a PSA \<=2.0ng/mL than initial PSA and/or no residual tumor or other lesion suspicious for prostate cancer on magnetic resonance imaging and/or no gleason score upgrading on re-biopsy and/or no clinical up-staging of prostate cancer T-stage
Secondary Outcomes
- PROM regarding voiding(12 months)
- PROM regarding erectile function(12 months)
- Safety of TPLA for PCa(Up to 12 weeks)
- Potency rate(12 months)
- Continence rate(12 months)
- Urinary flow(12 months)
- Feasibility of TPLA for PCa(Up to 4 weeks)