Ignite Creation Date:
2024-05-06 @ 1:57 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04170478
Status:
COMPLETED
Last Update Posted:
2021-10-18
First Post:
2019-10-30
Brief Title:
Transperineal Laser Ablation for Focal Treatment of Prostate Cancer
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Transperineal Laser Ablation for Focal Prostate Cancer Safety and Ablative Efficacy Evaluation Using Postradical Prostatectomy Histological Analysis
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TPLA for PCa
Brief Summary:
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 multifibre setup in men with localized prostate cancer The investigators hypothesize that TPLA will show adequate histological ablative efficacy and will be feasible and safe
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 multifibre setup in men with localized prostate cancer The investigators hypothesize that TPLA will show adequate histological ablative efficacy and will be feasible and safe
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL6990301819 | OTHER | Toetsingonline | None |