Focal Laser Ablation in Prostate Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age45+
SponsorAin Shams University
About this trial
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 \& functional outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Males with localized, intermediate risk prostatic adenocarcinoma
Trial design
Design model
Other
Time perspective
Retrospective
Treatments tested in this trial
Focal laser ablation
Procedure/SurgeryTargeted focal laser ablation
Focal laser ablation
Procedure/SurgeryTargeted focal laser ablation of localized intermediate-risk prostate cancer
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Prostatic adenocarcinoma1 intervention
Trial outcomes
Primary outcomes
1
Evaluation of short-term oncological outcome
Follow-up with clinical evaluation performed by mpMRI. mpMRI is done for assessment of tissue changes as well as residual or recurrent disease after 10 days, then after 3 months, after 6 months then every 6 months thereafter.
Time frame
12 monthsSecondary outcomes
1
Evaluation of functional outcome.
IIEF-5 questionnaire is submitted at 3, 6, 12 months.
Time frame
12 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: