Transperineal Laser Ablation Treatment (TPLA) for Prostate Cancer (PCa) Registry

Prostate Cancer Clinical Trial

— TPLAforPCa  

Official title:

Transperineal Laser Ablation Treatment for Prostate Cancer Registry: a Retrospective and Multicenter Evaluation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05163197
• Other study ID #: W21_458
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: October 1, 2027

Study information

• Verified date: December 2021
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: L. A. van Riel, MD
• Phone: +31 6 50 06 30 94
• Email: l.a.vanriel[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 1, 2027
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male, histological-confirmed disease of localized prostate cancer, TPLA treatment for PCa is performed

Exclusion Criteria:

• Age < 18 years

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Transperineal Laser Ablation of Prostate Cancer
Minimal invasive transperineal laser ablation treatment for prostate cancer

Locations

Country	Name	City	State
Netherlands	Amsterdam University Medical Centers	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oncological control	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	12 months
Secondary	Continence rate	Continence is assessed by usage of number of pads per day, and 0-1 pad per day usage is defined as continent.	12 months
Secondary	Potency rate	Potency is defined as erectile function sufficient for sexual intercourse, with or without medical aid	12 months
Secondary	Urinary flow	Urinary flow is assessed by peak urinary flow (mL/s) and residual urine (mL). The higher the peak urinary flow and the lower the residual urine, the better the urinary flow.	12 months
Secondary	PROM regarding voiding	International Prostate Symptom Score (IPSS) is used to determine functional outcome regarding voiding. IPSS is on a score of 0 to 35, and the higher the score the worse the outcome.	12 months
Secondary	PROM regarding erectile function	International Index of Erectile Function (IIEF-5) is used to determine erectile function based on a validated questionnaire. IIEF-5 is on a scale of 5 to 25, and the higher the score the better the outcome.	12 months
Secondary	Safety of TPLA for PCa	Safety is defined as 10% or less CTCAE (version 5) grade 3 and no CTCAE grade 4 or 5	Up to 12 weeks
Secondary	Feasibility of TPLA for PCa	Feasibility is assessed by amount of machine failures perioperatively of TPLA and hospital duration (hours) directly after TPLA.	Up to 4 weeks