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Completed

NCT Number: NCT02200809

MR-guided Focal Laser Ablation of the Prostate

Purpose of the investigators study is to determine the short and medium term histological cancer control of focal therapy using MR-guided focal laser ablation therapy in the treatment of localised prostate cancer.

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Key information

Conditions

Prostate Cancer Focal Laser Ablation Genital Diseases Genital Diseases, Male Genital Neoplasms, Male MRI 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

Interventional

Phase

Not applicable

Primary location

Canisius Wilhelmina Hospital, Nijmegen, Gelderland, Netherlands

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Newly diagnosed and biopsy proven prostate cancer
  • Intermediate risk patients (PSA <= 20 ng/mL, Gleason ≤ 7, T2b)
  • No previous treatment for prostate cancer
  • Cancer lesion located at least 1 cm away from the neurovascular bundle according to Multimodality MR images
  • Signed informed consent by patient
  • Age 18 years or older
  • Signed screening form (to determine exclusion for metal device/foreign bodies/claustrophobia)

Exclusion criteria

  • 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

Treatment and study plan

MR-guided focal laser ablation

Device

Primary outcomes

  1. Disease free survival

    Time frame: 36 months.

    The short and medium term histological cancer control defined as the percentage of patients with disease free survival according to the pathological MR-guided biopsy results after 36 months.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Canisius-Wilhelmina Hospital
  • Ziekenhuisgroep Twente

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jul 25, 2014
Registry last updated
Apr 24, 2020

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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