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NCT04045756

Focal Laser Ablation for the Treatment of Focal Low-Intermediate Risk Prostate Cancer

Status unknown NA Last updated 17 December 2019
What this trial tests

NA trial testing Procedure/Surgery: Transperineal Focal Laser Ablation (TPLA) in Prostate Cancer in 50 participants. Status unknown.

Timeline
2 August 2019
Primary endpoint
2 August 2020
2 August 2024

Quick facts

Lead sponsorUniversity of Rome Tor Vergata
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment50
Start date2 August 2019
Primary completion2 August 2020
Estimated completion2 August 2024
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

University of Rome Tor Vergata

Who can join

Adults 46 to 86, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Short-term Efficacy of Transperineal Laser Ablation (TPLA) with Image Fusion and Multi-parametric (mpMRI) Follow-up in Focal Low-intermediate Risk Prostate Cancer. It is an interventional pilot study. The clinical evaluation will be carried out at different times as follows: Time 0: recruitment and eligibility assessment (patient selection) Time 1: interview, signing of informed consent and enrollment Time 2: FLA treatment and control with multiparametric MRI of the post-procedural prostate. Time 3-4-5-6: follow up to 1 (T3), 6 (T4), 12 (T5) and 24 (T6) months from the procedure. The primary objective of the study is to evaluate the short-term (2 years) efficacy of FLA treatment of low-intermediate risk prostate cancer Secondary objective is to investigate multiparametric prostate MRI as a follow-up diagnostic investigation, evaluating possible glandular morphostructural changes and their correlation with clinical data.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Focal ablation therapy presents promising results for selectively localized prostate cancer patients.
    Feng D, Li D, Xiao Y, Wu R, et al · · 2023 · cited 22× · PMID 37691892 · DOI 10.21147/j.issn.1000-9604.2023.04.08
  2. Transperineal Laser Ablation (TPLA) Treatment of Focal Low-Intermediate Risk Prostate Cancer.
    Manenti G, Perretta T, Nezzo M, Fraioli FR, et al · · 2024 · cited 10× · PMID 38611082 · DOI 10.3390/cancers16071404
  3. TransPerineal Laser Ablation (TPLA) Treatment of Focal Low-Intermediate Risk Prostate Cancer
    Manenti G, Perretta T, Nezzo M, Fraioli FR, et al · · 2024 · DOI 10.20944/preprints202402.1578.v1

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Other recruiting trials for Prostate Cancer

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Data sources for this page

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