Prostate Cancer Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | August 2, 2024 |
Est. primary completion date | August 2, 2020 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 46 Years to 86 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Policlinico Tor Vergata (PTV) Foundation: Department di Biomedicine and Prevention | Rome | RM |
Lead Sponsor | Collaborator |
---|---|
University of Rome Tor Vergata |
Italy,
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Goldberg SN, Grassi CJ, Cardella JF, Charboneau JW, Dodd GD 3rd, Dupuy DE, Gervais D, Gillams AR, Kane RA, Lee FT Jr, Livraghi T, McGahan J, Phillips DA, Rhim H, Silverman SG; Society of Interventional Radiology Technology Assessment Committee. Image-guided tumor ablation: standardization of terminology and reporting criteria. J Vasc Interv Radiol. 2005 Jun;16(6):765-78. — View Citation
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Patelli G, Ranieri A, Paganelli A, Mauri G, Pacella CM. Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia: A Feasibility Study. Cardiovasc Intervent Radiol. 2017 Sep;40(9):1440-1446. doi: 10.1007/s00270-017-1662-9. Epub 2017 May 4. — View Citation
van Luijtelaar A, Greenwood BM, Ahmed HU, Barqawi AB, Barret E, Bomers JGR, Brausi MA, Choyke PL, Cooperberg MR, Eggener S, Feller JF, Frauscher F, George AK, Hindley RG, Jenniskens SFM, Klotz L, Kovacs G, Lindner U, Loeb S, Margolis DJ, Marks LS, May S, Mcclure TD, Montironi R, Nour SG, Oto A, Polascik TJ, Rastinehad AR, De Reyke TM, Reijnen JS, de la Rosette JJMCH, Sedelaar JPM, Sperling DS, Walser EM, Ward JF, Villers A, Ghai S, Fütterer JJ. Focal laser ablation as clinical treatment of prostate cancer: report from a Delphi consensus project. World J Urol. 2019 Oct;37(10):2147-2153. doi: 10.1007/s00345-019-02636-7. Epub 2019 Jan 22. — View Citation
Walser E, Nance A, Ynalvez L, Yong S, Aoughsten JS, Eyzaguirre EJ, Williams SB. Focal Laser Ablation of Prostate Cancer: Results in 120 Patients with Low- to Intermediate-Risk Disease. J Vasc Interv Radiol. 2019 Mar;30(3):401-409.e2. doi: 10.1016/j.jvir.2018.09.016. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease free survival | 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. | 5 years | |
Primary | Evaluation of Complications of prostate Laser Ablation on the Treatment of Focal Low-Intermediate Risk Prostate Cancer by use of mp-MRI. | Evaluation of the post-procedural complications by mpMRI. In particular damage to neuro-vascular bundles, seminal vescicles and peri-prostatic fat will be checked. | 5 years | |
Secondary | Reproducibility of mpMRI in correlation with biopsy in order to establish positive/negative predictive diagnostic values of MRI in residual/relapsing tumors | 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. | 5 years |
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