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

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ClinicalTrials.gov Identifier: NCT05163197
Recruitment Status : Recruiting
First Posted : December 20, 2021
Last Update Posted : December 20, 2021
Sponsor:
Information provided by (Responsible Party):
Prof.dr. H.P. Beerlage, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Prostate Cancer Procedure: Transperineal Laser Ablation of Prostate Cancer

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Transperineal Laser Ablation Treatment for Prostate Cancer Registry: a Retrospective and Multicenter Evaluation
Actual Study Start Date : October 1, 2021
Estimated Primary Completion Date : October 1, 2026
Estimated Study Completion Date : October 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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Intervention Details:
  • Procedure: Transperineal Laser Ablation of Prostate Cancer
    Minimal invasive transperineal laser ablation treatment for prostate cancer
    Other Names:
    • Soractelite treatment
    • Echolaser X4

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The registry population comprises those patients that have been treated with TPLA for PCa.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Age < 18 years
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05163197


Contacts
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Contact: L. A. van Riel, MD +31 6 50 06 30 94 l.a.vanriel@amsterdamumc.nl
Contact: J. R. Oddens, MD, PhD +31 6 50 06 30 94 j.r.oddens@amsterdamumc.nl

Locations
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Netherlands
Amsterdam University Medical Centers Recruiting
Amsterdam, Netherlands
Contact: L. A. van Riel, MD    +31 6 50 06 30 94    l.a.vanriel@amsterdamumc.nl   
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Principal Investigator: J. R. Oddens, MD, PhD Principal Investigator
More Information
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Responsible Party: Prof.dr. H.P. Beerlage, Professor, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT05163197    
Other Study ID Numbers: W21_458
First Posted: December 20, 2021    Key Record Dates
Last Update Posted: December 20, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof.dr. H.P. Beerlage, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Laser Ablation
Minimal invasive
Focal therapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases