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Search / Trial NCT06916013

Focal Laser Ablation in Prostate Cancer

Launched by AIN SHAMS UNIVERSITY · Apr 4, 2025

Trial Information

Current as of July 09, 2025

Not yet recruiting

Keywords

Prostate Cancer Laser

ClinConnect Summary

This clinical trial is looking at a new treatment called focal laser ablation (FLA) for men with localized, intermediate-risk prostate cancer. The goal is to see if using advanced imaging techniques like MRI and PET scans can help doctors precisely target and treat the cancer while preserving important functions, like urinary control. The trial aims to evaluate how effective this treatment is in the short term for both cancer control and quality of life.

To participate in this trial, men must have prostate cancer that can be seen on an MRI or PET scan and has been confirmed through a biopsy. They should have a Gleason score of 7 (which indicates a certain level of cancer aggressiveness) and a PSA level between 10 and 20 ng/mL. Participants should also be in the clinical stage T2b and have chosen not to undergo more invasive surgery like radical prostatectomy. The trial is not yet recruiting, but it's important for eligible men and their families to know that this study could offer a new option for treating their prostate cancer with potentially fewer side effects.

Gender

MALE

Eligibility criteria

  • Inclusion Criteria:
  • Prostate cancer visible on mpMRI or PSMA PET/CT and positive in the targeted biopsy.
  • Gleason score 7 (ISUP grade 2/3)
  • PSA 10-20 ng/mL
  • Clinical stage T2b
  • Refusing radical prostatectomy.
  • Exclusion Criteria:
  • Prostate cancer invisible on mpMRI or PSMA PET/CT but positive in the systematic biopsies.
  • Presence of \>2 MRI-visible lesions and positive in the biopsies.
  • Extracapsular extension
  • Seminal vesicle invasion
  • Presence of metastases detected by imaging
  • Gleason Score \> 7
  • Stage \> T2b
  • PSA \> 20 ng/mL
  • Urinary tract infection (UTI)
  • Severe lower urinary tract symptoms defined as an IPSS \>20
  • Severe coagulation disorders
  • Inadequate compliance
  • Contraindications to MRI
  • Paramagnetic contrast agent allergy
  • Acute and/or chronic renal failure

About Ain Shams University

Ain Shams University, established in Cairo, Egypt, is a prestigious higher education institution renowned for its commitment to academic excellence and research innovation. As a clinical trial sponsor, the university leverages its extensive resources and expertise in various medical and scientific disciplines to advance healthcare through rigorous research initiatives. With a focus on ethical practices and adherence to regulatory standards, Ain Shams University aims to contribute to the development of new therapies and improve patient outcomes, fostering collaboration among researchers, healthcare professionals, and industry partners in the pursuit of medical advancements.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported