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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: Transperineal Laser Ablation of Prostate Cancer

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: L. A. van Riel, MD; Phone Number: +31 6 50 06 30 94; Email: l.a.vanriel@amsterdamumc.nl
• Study Contact Backup: Name: J. R. Oddens, MD, PhD; Phone Number: +31 6 50 06 30 94; Email: j.r.oddens@amsterdamumc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Amsterdam University Medical Centers
    • Contact: L. A. van Riel, MD; Phone Number: +31 6 50 06 30 94; Email: l.a.vanriel@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

The registry population comprises those patients that have been treated with TPLA for PCa.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Age < 18 years

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Potency rate	Potency is defined as erectile function sufficient for sexual intercourse, with or without medical aid	12 months
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: J. R. Oddens, MD, PhD, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Anticipated): October 1, 2026
• Study Completion (Anticipated): October 1, 2027

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (Actual): December 20, 2021

Study Record Updates

• Last Update Posted (Actual): December 20, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Minimal invasive; Focal therapy; Laser Ablation
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: W21_458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No