Transperineal Targeted Focal Laser Ablation of Localized Intermediate Risk Prostatic Adenocarcinoma (Pilot Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Evaluation of short-term oncological outcome
研究概览
简要总结
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.
详细描述
Prostate cancer (PCa) is the second most common neoplasm diagnosed in men with an estimated 1.4 million diagnoses and 375,000 deaths worldwide in 2020.
For localized prostate cancer (PCa), active surveillance (AS) or whole gland treatment (ie, radical prostatectomy [RP] and radiotherapy) are considered standard treatment options. Unfortunately, treatment-related morbidity is high.
The ProtecT trial showed urinary incontinence rates of 3% and 20% and erectile dysfunction rates of 66% and 79% for radiotherapy and radical prostatectomy, respectively. Radiotherapy can also cause rectal problems with a small increased risk of radiotherapy-induced secondary malignancy.
Consequently, over the past few years, there has been a notable escalation in scholarly attention towards the implementation of focal therapeutic interventions for patients diagnosed with low- and intermediate-risk prostate cancer (PCa).
This tissue-preserving strategy has at its core the reduction of treatment-related toxicity by minimizing damage caused to the prostate and adjacent structures while attempting to retain the benefits of treating cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
- •Refusing radical prostatectomy.
排除标准
- •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
- •Presence of metastases detected by imaging
- •Gleason Score > 7
- •Stage > T2b
- •PSA > 20 ng/mL
- •Urinary tract infection (UTI)
- •Severe lower urinary tract symptoms defined as an IPSS >20
- •Severe coagulation disorders
- •Inadequate compliance
- •Contraindications to MRI
- •Paramagnetic contrast agent allergy
- •Acute and/or chronic renal failure
结局指标
主要结局
Evaluation of short-term oncological outcome
时间窗: 12 months
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.
次要结局
- Evaluation of functional outcome.(12 months)