NCT04170478|CompletedDMC
Transperineal Laser Ablation for Focal Treatment of Prostate Cancer
TPLA for PCa
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TPLA for PCa
Sponsor study identifier
Secondary identifiers
OTHER · Toetsingonline
interventional
12
1 country
1
Study Start
August 1, 2020
Actual (reported)Primary Completion
October 15, 2021
Actual (reported)Study Completion
October 15, 2021
Actual (reported)Rationale: Prostate cancer (PCa) is the second cause of cancer-related deaths for men. The standard surgical treatment for localised prostate cancer is radical prostatectomy. Possible side effects of this treatment are incontinence and erectile dysfunction and this is related to the whole-gland resection. A focal treatment with fewer side effects is desired for patients with only a small focus of PCa. For this purpose, focal laser ablation is feasible. Current focal laser ablation techniques use a single fibre setup with the need for fibre replacement revisualisation of the tumour side accordingly. This leads to a long treatment duration. The Echolaser® system is a laser ablation system with four simultaneously operating laser sources. This provides a potential larger treatment area, without the need for fibre replacement. This makes the system advantageous for focal laser ablation of prostate cancer, especially since it can be applied under local anaesthesia. This pilot study aims to evaluate histological ablative efficacy on radical prostatectomy specimens following TPLA, feasibility and safety using a (multi)fibre setup in men with localized prostate cancer. The investigators hypothesize that TPLA will show adequate histological ablative efficacy and will be feasible and safe.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 15, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 30, 2019
Actual (reported)November 20, 2019
Actual (reported)August 1, 2020
Actual (reported)October 15, 2021
Actual (reported)October 15, 2021
Actual (reported)Ablative efficacy of transperineal laser ablation determined by size of the ablation zone in histopathology, which is measured by absence of vital prostatic cells, compared to the size measured on imaging (CEUS/MRI) during and after treatment
Histological ablative efficacy is assessed on histopathological analysis of the prostatic tissue after radical prostatectomy by means of the absence of vital cells in the treated prostate zone
30 days following TPLA treatment
Safety is assessed by device and procedural adverse events using the CTCAEv5.0 until radical prostatectomy and feasibility is determined by procedural success of the TPLA treatment.
30 days following TPLA treatment
Size of ablation zone
Transperineal laser ablation
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Academic Medical Center
Amsterdam, North Holland, 1105AZ, Netherlands
J R Oddens, MD, PhD
Urologist
12 participants (actual enrollment reported by the registry).
First Submitted
October 30, 2019
First Posted
November 20, 2019
Study Start
August 1, 2020
Actual (reported)The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy
30 days following TPLA treatment
Observation of tissue changes seen on imaging during and after treatment compared to histopathology
30 days following TPLA treatment
Functional outcomes measured using PROMs (VAS, IPSS, IIEF-15, EPIC)
30 days following TPLA treatment
Contact the study team to confirm eligibility.
Primary Completion
October 15, 2021
Actual (reported)Study Completion
October 15, 2021
Actual (reported)Last Updated
October 18, 2021
Record last verified: 2021-10
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Source: ClinicalTrials.gov.
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