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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Evaluation of Complications of prostate Laser Ablation on the Treatment of Focal Low-Intermediate Risk Prostate Cancer by use of mp-MRI.
研究概览
简要总结
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.
详细描述
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 recruitment and evaluation of eligibility will be done by the Multidisciplinary Neoplasms Group of the Uro-Genital System, already operating within the Tor Vergata Polyclinic Foundation and formed by the following Operating Units:
UOSD Urology, UOC Diagnostic Imaging, UOC Medical Oncology, UOC Radiotherapy, UOSD Pathological Anatomy, UOC Nuclear Medicine. The Multidisciplinary Group will propose and evaluate patients that can be recruited based on inclusion and exclusion criteria. The patient considered eligible for the study will be adequately informed by the UOSD Urology / UOC Diagnostic Imaging regarding the therapeutic possibilities for the specific disease stage.
If the patient expresses an interest in participating in the study, he will be given informed consent.
Once the informed consent has been signed, the patient will be considered enrolled in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 46 Years 至 86 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Prostate cancer Gleason Score> = 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
结局指标
主要结局
Evaluation of Complications of prostate Laser Ablation on the Treatment of Focal Low-Intermediate Risk Prostate Cancer by use of mp-MRI.
时间窗: 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.
Disease free survival
时间窗: 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.
次要结局
- Reproducibility of mpMRI in correlation with biopsy in order to establish positive/negative predictive diagnostic values of MRI in residual/relapsing tumors(5 years)
研究者
Guglielmo Manenti
Principal Investigator
University of Rome Tor Vergata