Status:
NOT_YET_RECRUITING
Focal Laser Ablation in Prostate Cancer
Lead Sponsor:
Ain Shams University
Conditions:
Prostate Cancer
Laser
Eligibility:
MALE
45+ years
Brief Summary
To assess the effectiveness of MRI-US or PSMA PET/CT-U/S fusion-guided focal laser ablation (FLA) for the treatment of a localized, intermediate-risk prostate cancer in terms of short-term oncological...
Detailed Description
Prostate cancer (PCa) is the second most common neoplasm diagnosed in men with an estimated 1.4 million diagnoses and 375,000 deaths worldwide in 2020. For localized prostate cancer (PCa), active sur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 20 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 20 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06916013
Start Date
April 20 2025
End Date
August 20 2027
Last Update
April 8 2025
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