Detection of Clinically Significant Prostate Cancer With 18F-DCFPyL PET/MR
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Rate of clinically significant prostate cancer (csPCa) detected in the study population by 18F-DCFPyL-PET/mpMR as compared to mpMR alone
研究概览
简要总结
Background:
Currently, patients suspected of having prostate cancer undergo ultrasound-guided systematic biopsies of the prostate. However, up to a quarter of clinically significant tumors, which may pose a risk to patient's well-being, may be missed on random biopsies. MRI enables detection of further tumors in this patient population, but also has limited accuracy.
Study hypothesis:
We hypothesize that hybrid PET-MRI, a novel scanner which incorporates MRI with molecular imaging will improve the detection rate of clinically significant tumors.
Study design:
In this prospective trial, we will recruit 57 men who are suspected of having prostate cancer but have had negative systematic biopsies, who have been diagnosed with low-risk disease but have clinically signs of more aggressive tumor or who have a focal tumor detected and are candidates for minimally-invasive tumor ablation (=tumor destruction with laser or ultrasound waves), in whom it is crucial to exclude other tumor sites.
All patients will undergo PET/MRI after injection of a radiopharmaceutical called "18F-DCFPyL". This is a radioactive probe which has been shown in preliminary studies to be sensitive and specific for detection of prostate cancer.
All lesions detected on PET/MRI will undergo biopsy under ultrasound using fused PET/MRI and ultrasound images for guidance, and compared to histopathology. The primary outcome measure in this study is the proportion of clinically significant prostate cancers that are detected with PET/MRI compared to MRI alone. Improved detection of clinically significant prostate cancer may enable a tailored, personalized therapeutic approach, decreasing morbidity and potentially improving overall patient outcome.
详细描述
Prostate cancer overview:
Prostate cancer (PCa) is the 3rd leading cause of death from cancer in men and constitutes almost 1/4 of all new cancer cancers in men. Although PCa is prevalent, the risk of clinical or fatal PCa in a 50 year old man is estimated at only 10% and 3%, respectively Currently, over 2/3 of men diagnosed with PCa are diagnosed with organ confined, low risk disease (PSA < 10 ng/ml, Gleason score (=GS) 3+3, cT1c). Management is depending on tumor grade, size and stage and clinical parameters (e.g. life expectancy) and may range from active surveillance to radical therapy including definitive whole gland treatment (radical prostatectomy (RP), or radiotherapy). Although radical whole gland therapy is effective from an oncological standpoint, it may be associated with significant side effects. A more conservative approach in select patients may be enrollment in an active surveillance program. The concept behind this approach is that small volume, low grade PCa may have an indolent course and may not progress to biological significance in the absence of treatment in the patient's lifetime.
Conventional workup of patients with clinical suspicion of PCa:
Transrectal Ultrasound (TRUS)-guided biopsies: Current workup of patients with clinical suspicion of PCa includes TRUS-guided systematic biopsies. These are associated with a relatively high false negative rate, especially for areas difficult to access for biopsy, with csPCa missed in approximately 1 of 4 patients. Furthermore, there is only ˜50% correlation between biopsy obtained GS and final pathology at RP, with upgrading in more than 1 in 3 cases. This may lead to inaccurate risk stratification and inappropriate selection of therapy.
Role of multiparametric-MR & MR-Ultrasound Fusion Biopsy:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients accrued will fit any of the following criteria:
- •Clinical suspicion of PCa with negative TRUS-guided biopsy or clinically discordant low-risk PCa (suspicion of more extensive/aggressive disease).
- •Potential candidates for FT (as per institutional guidelines).
排除标准
- •Patients will be ineligible to participate in this study if they meet any of the following criteria:
- •Contraindication for MR as per current institutional guidelines.
- •Contraindication for Gadolinium injection as per current institutional guidelines.
- •Inability to lie supine for at least 60 minutes.
- •Prostate biopsy <8 weeks prior to planned PET-MR.
结局指标
主要结局
Rate of clinically significant prostate cancer (csPCa) detected in the study population by 18F-DCFPyL-PET/mpMR as compared to mpMR alone
时间窗: Through study completion, up to 2 years
We will compare rates of csPCa detection in 18F-DCFPyL-PET, mpMR and fused 18F-DCFPyL-PET/mpMR, with histopathology obtained at targeted fused US-PET/MR biopsy as the standard of reference
次要结局
- Change in eligibility for focal therapy according to each modality(Through study completion, up to 2 years)
- Correlation of tumor grade to PSMA expression on PET (SUV).(Through study completion, up to 2 years)