Status:
UNKNOWN
Focal Laser Ablation for the Treatment of Focal Low-Intermediate Risk Prostate Cancer
Lead Sponsor:
University of Rome Tor Vergata
Conditions:
Prostate Cancer
Eligibility:
MALE
46-86 years
Phase:
NA
Brief Summary
Short-term Efficacy of Transperineal Laser Ablation (TPLA) with Image Fusion and Multi-parametric (mpMRI) Follow-up in Focal Low-intermediate Risk Prostate Cancer. It is an interventional pilot study....
Detailed Description
Short-term Efficacy of Transperineal Laser Ablation (TPLA) With Image Fusion and Multi-parametric (mpMRI) Follow-up in Focal Low-intermediate Risk Prostate Cancer. It is an interventional pilot study....
Eligibility Criteria
Inclusion
- Male
- Over 45 years old
- Prostate cancer identified after prostatic biopsy with fusion of images with target and systematic samples (\> 12)
- Intermediate progression risk (Gleason Score 3 + 4 or 4 + 3; PSA \<15 ng / ml; clinical stage T1-T2a)
- Low risk of progression (Gleason score 3 + 3) only in patients who wish to leave or who refuse the active surveillance protocol and who refuse validated treatments for the treatment of organo-confined prostate cancer: radical surgery and / or radiotherapy
Exclusion
- Prostate cancer Gleason Score\> = 4 + 4.
- Clinical stage\> T2a
- PSA\> 15 ng / ml
- Presence of metastases from prostate lymph node, bone or visceral carcinoma detected by bone scintigraphy, total body CT or PET-CT
- Serious coagulation disorders not correctable
- Unavailable or replaceable anticoagulant and / or antiplatelet therapy
- Inadequate compliance
- Presence of pacemakers
- Contraindications to MRI (claustrophobia, ear implants, metal prostheses)
- Paramagnetic contrast agent allergy
- Acute and / or chronic renal failure (GFR \<50 mL / min and serum creatinine\> 1.5 mg / dl)
- Tumor volume \<15 ml measured on MRI
Key Trial Info
Start Date :
August 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 2 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04045756
Start Date
August 2 2019
End Date
August 2 2024
Last Update
December 17 2019
Active Locations (1)
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1
Policlinico Tor Vergata (PTV) Foundation: Department di Biomedicine and Prevention
Rome, RM, Italy, 00133