MRI-guided Focal Laser Ablation (Unicorn)

R

Radboud University Medical Center

Status and phase

Enrolling
Phase 2

Conditions

Prostate Cancer

Treatments

Procedure: Focal laser ablation

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04379362
NL63647.091.17

Details and patient eligibility

About

Magnetic resonance imaging-guided focal laser ablation of prostate cancer.

Enrollment

53 estimated patients

Sex

Male

Ages

45 to 76 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • MRI visible index lesion (on T2-weighted MR imaging or diffusion weighted imaging);
  • Maximum MRI visible lesion size is ≤ 15 mm large axis;
  • Life expectancy at inclusion of more 10 years;
  • Diagnosis of prostate cancer confirmed by targeted biopsy using TRUS-MRI fusion or in-bore MRI guided biopsies;
  • 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.

Exclusion criteria

  • 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 MRI signs of extra-capsular extension or invasion of the seminal vesicles;
  • Maximum cancer core length >3 mm and/or maximum Gleason score of 3+4 on systematic biopsies outside the visible tumor area on mpMRI;
  • 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

53 participants in 1 patient group

Low or intermediate grade prostate cancer
Experimental group
Treatment:
Procedure: Focal laser ablation

Trial contacts and locations

0

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Central trial contact

Joyce Bomers, PhD; Annemarijke van Luijtelaar, MD

Data sourced from clinicaltrials.gov

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