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NCT Number: NCT05163197

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age < 18 years

Treatment and study plan

Transperineal Laser Ablation of Prostate Cancer

Procedure

Minimal invasive transperineal laser ablation treatment for prostate cancer

Other names: Soractelite treatment, Echolaser X4

Primary outcomes

  1. 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

  1. Continence rate

    Time frame: 12 months

    Continence is assessed by usage of number of pads per day, and 0-1 pad per day usage is defined as continent.

  2. Potency rate

    Time frame: 12 months

    Potency is defined as erectile function sufficient for sexual intercourse, with or without medical aid

  3. Urinary flow

    Time frame: 12 months

    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.

  4. PROM regarding voiding

    Time frame: 12 months

    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.

  5. PROM regarding erectile function

    Time frame: 12 months

    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.

  6. Safety of TPLA for PCa

    Time frame: Up to 12 weeks

    Safety is defined as 10% or less CTCAE (version 5) grade 3 and no CTCAE grade 4 or 5

  7. Feasibility of TPLA for PCa

    Time frame: Up to 4 weeks

    Feasibility is assessed by amount of machine failures perioperatively of TPLA and hospital duration (hours) directly after TPLA.

Study contacts

Contact information is provided by the study sponsor or research team.

J. R. Oddens, MD, PhD

CONTACT

[email protected]

+31 6 50 06 30 94

L. A. van Riel, MD

CONTACT

[email protected]

+31 6 50 06 30 94

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

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

Acronym: TPLAforPCa

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Dec 20, 2021
Registry last updated
Dec 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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