Focal Laser Ablation for the Treatment of Focal Low-Intermediate Risk Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT04045756|
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : December 17, 2019
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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. The clinical evaluation will be carried out at different times as follows:
Time 0: recruitment and eligibility assessment (patient selection) Time 1: interview, signing of informed consent and enrollment Time 2: FLA treatment and control with multiparametric MRI of the post-procedural prostate.
Time 3-4-5-6: follow up to 1 (T3), 6 (T4), 12 (T5) and 24 (T6) months from the procedure.
The primary objective of the study is to evaluate the short-term (2 years) efficacy of FLA treatment of low-intermediate risk prostate cancer Secondary objective is to investigate multiparametric prostate MRI as a follow-up diagnostic investigation, evaluating possible glandular morphostructural changes and their correlation with clinical data.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: Procedure/Surgery: Transperineal Focal Laser Ablation (TPLA)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Short-term Efficacy of Transperineal Laser Ablation (TPLA) With Image Fusion and Multi-parametric (mpMRI) Follow-up in Focal Low-intermediate Risk Prostate Cancer: Interventional Pilot Study|
|Actual Study Start Date :||August 2, 2019|
|Estimated Primary Completion Date :||August 2, 2020|
|Estimated Study Completion Date :||August 2, 2024|
Experimental: ECHOLASER X4 Socratelite
Optic fiber of 300um will be inserted at a distance of 8-10mm from the urethra. Each ablation lasts 6 minutes. Each fiber ablates at an energy of 1800J with a power of 2-3W. Treatment lasts for about 30 minutes.
Device: Procedure/Surgery: Transperineal Focal Laser Ablation (TPLA)
The intervention will take place in an ambulatory setting of the interventional radiology department using the combined Echolaser XVG system. The treatment consists of a local anesthesia to the perineal region. Within each needle, an optic fiber of 300um will be inserted. Each ablation lasts 6 minutes and each fiber ablates 1800J at a power of 2-3W. At the end of the ablation there is a pull-back of about 1cm from the original ablation location. According to the dimension of the middle lobe of the prostate, multiple pullbacks can be used. The total ablation is 3600J for 2 fibers (1800J/ fiber) at the power of 2-3W for a total duration of about 30minutes. At the end of the treatment, a 20mg bollous of i.v. corticosteriods () is given for anti-edema and anti-inflammatory effects. Antibiotic therapy (Cirpofloxacin 500mg and gastroprotective therapy is given for 5 days. After an adequate amount of time for observation, the patient is dismissed.
- Disease free survival [ Time Frame: 5 years ]Cancer control defined as the percentage of patients with disease free survival according to the pathological MR-guided biopsy results in a 5 year period.
- Evaluation of Complications of prostate Laser Ablation on the Treatment of Focal Low-Intermediate Risk Prostate Cancer by use of mp-MRI. [ Time Frame: 5 years ]Evaluation of the post-procedural complications by mpMRI. In particular damage to neuro-vascular bundles, seminal vescicles and peri-prostatic fat will be checked.
- Reproducibility of mpMRI in correlation with biopsy in order to establish positive/negative predictive diagnostic values of MRI in residual/relapsing tumors [ Time Frame: 5 years ]Evaluation of multi-parametric MRI of the prostate and evaluate the response to focal laser ablation treatment for focal low-intermediate prostate cancer by biopsy.
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|Ages Eligible for Study:||46 Years to 86 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04045756
|Contact: Guglielmo Manenti, MD PhD||39 email@example.com|
|Contact: Salvatore Marsico, MD PhDfirstname.lastname@example.org|
|Policlinico Tor Vergata (PTV) Foundation: Department di Biomedicine and Prevention||Recruiting|
|Rome, RM, Italy, 00133|
|Contact: Guglielmo Manenti, MD PhD +39 0620902281 email@example.com|
|Contact: Roberto Floris, MD PhD +39 0620902400 firstname.lastname@example.org|
|Principal Investigator:||Guglielmo Manenti, MD PhD||Fondazione Policlinico Tor Vergata|
Documents provided by Guglielmo Manenti, University of Rome Tor Vergata:
|Responsible Party:||Guglielmo Manenti, Principal Investigator, University of Rome Tor Vergata|
|Other Study ID Numbers:||
|First Posted:||August 6, 2019 Key Record Dates|
|Last Update Posted:||December 17, 2019|
|Last Verified:||December 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Create an international registry to assess long-term effectiveness of transperineal laser ablation for focal prostate cancer, to assess functional outcomes, to assess safety, to determine baseline patient characteristics, to collect information on possible differences between centres applying treatment of transperineal laser ablation and to explore the optimal treatment indications and possible limitations. It an international prospective observational registry in which data is recorded of patients who are treated with transperineal laser ablation for low-intermediate risk focal prostate cancer.|
Informed Consent Form (ICF)
|Time Frame:||This registry will be open for inclusion for five years. Since individual patients will have a follow-up of five years, the total study duration will be 10 years.|
|Access Criteria:||Every accredited centre that performs TPLA procedures, wants to participate and signs the regulatory document and obtains ethical committee approval can participate|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Product Manufactured in and Exported from the U.S.:||Yes|
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