MRI-guided Focal Laser Ablation Prostate Cancer

NCT05370482 | Unknown DMC

• 1 other identifier: 2021-13069
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Prostate cancer is the most frequent malignancy in the male population of developed countries and has a substantial socio-economic impact. Focal therapies, including focal laser ablation (FLA), are gaining ground as a novel strategy to treat organ-confined low- to intermediate risk PCa while preserving healthy tissue and reduce treatment-related morbidity associated with radical treatments. This project has the goal to perform a feasibility study on magnetic resonance imaging (MRI)-guided focal laser ablation using the TRANBERG®\|Thermoguide Therapy System including TRANBERG®Thermoguide Workstation for MR thermometry developed by the company CLS AB.

Conditions

Prostate Neoplams, Magnetic Resonance Imaging, Laser Ablation

Outcome Measures

Primary Outcomes (2)

• completion of complete ablation without technical failures

  completion of laser ablation without technical failures, achievement of complete ablation shown by MRI after treatment calculated using image co-registration software, total procedure time, total numver of fiber positions and ablations needed

  1 day

• procedure-related adverse events and complications following SIR criteria

  procedure-related adverse events and complications following SIR criteria

  6 months

Secondary Outcomes (3)

• tumor response

  6 months

• (local) progression free survival (PFS) at 6 months

  6 months

• incontinence en potency rate

  6 months

Study Arms (1)

MRI-guided focal laser ablation

EXPERIMENTAL

Device: Focal laser ablation

Interventions

Focal laser ablation DEVICE

MRI-guided focal laser ablation for prostate cancer

MRI-guided focal laser ablation

Eligibility Criteria

• Age: 45 Years - 76 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• MRI visible index lesion (on T2-weighted MR imaging or diffusion weighted imaging);
• maximum MRI visible lesion size is ≤ 20 mm large axis;
• age 45 to 76 years old;
• diagnosis of prostate cancer confirmed by targeted biopsy;
• criteria of low and intermediate risk of progression and eligibility for focal therapy;
• clinical stage of maximum T2c
• maximum biopsy Gleason score of 4 + 3 on targeted biopsies
• serum prostate specific antigen \< 15 ng/ml
• patient accepting to be included in an active surveillance protocol at the end of the study, in accordance with the recommendations of good practice.

You may not qualify if:

• History of prostate surgery;
• history of radiation therapy or pelvic trauma; history of proved acute or chronic prostatitis;
• history of tumor in the preceding 5 years (excluded: non-metastatic basal cell skin cancer);
• severe urinary symptoms associated with benign hyperplasia of the prostate, and defined by an IPSS score \> 18;
• tumor with extra-capsular extension or invasion of the seminal vesicles;
• patients with \>2 lesions;
• impossibility to obtain a valid informed consent;
• patients unable to undergo MR imaging, including those with contra-indications;
• contra-indications to MR guided focal laser therapy (colitis ulcerosa, rectal pathology or abdomino perineal resection);
• metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging;
• patients with evidence for nodal or metastatic disease;
• patients with an estimated Glomerular Filtration Ratio (eGFR) \< 40 mL/min/1.73 m2

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

Study Officials

• Jurgen Fütterer

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yvonne Wimper

CONTACT

+31243611111; Yvonne.Wimper@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: CLS, Tranberg, Laser system

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 11, 2022
• Study Start: April 11, 2022
• Primary Completion: October 11, 2023
• Study Completion: April 11, 2025
• Last Updated: October 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)