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临床试验/NCT03160794
NCT03160794已完成不适用

Phase II Study: [18F]DCFPyL PET/MRI for Personalizing Prostate Cancer Subclinical Metastatic Ablative MR-guided Radiotherapy (MRgRT)

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年5月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
2
主要终点
To determine if [18F]DCFPyL PET-MR/CT can identify early oligometastatic disease in patients with a rising PSA and negative staging (CS and BS) after standard-of-care maximal local therapies.

研究概览

简要总结

In the clinical scenario of recurrent prostate cancer (PCa) post local therapy, current standard studies (bone scan and computed tomography) commonly fail to identify the recurrent disease location. In this study the investigator aims to prospectively map recurrent disease with the unique combination of whole-body MR anatomical imaging combined with a new high-sensitivity and PCa-specific PET probe (PSMA-targeted: [18F]DCFPyL) to provide precise localization information to target disseminated tumor deposits in men presenting with rising PSA after prostatectomy and radiotherapy (maximal local therapies). Moreover, we will consequently treat all identified disease with image-guided stereotactic ablative radiotherapy (SABR), which has shown tantalizing results achieving excellent tumor eradication rates with minimal toxicities. This study is uniquely positioned to enable the discovery of new biomarkers and the correlation of prognostic tests (e.g. genomic signatures) from the initial prostatectomy specimen with the PET-MR/CT imaging results and curative-intent treatment outcomes.

The significance of the proposed work towards a measurable impact in PCa care is important to emphasize. The study team believes this novel curative-intent approach will transform lives, as opposed to therapies that transiently impact incurable disease stages. Herein, the focus is on patients at the earliest point of the disease spectrum of recurrent PCa after curative-intent treatments. Our hypothesis is that PSMA-targeted [18F]DCFPyL PET-MR/CT allows earlier detection and localization of defined metastatic targets in these patients, at a stage amenable to image-guided curative-intent therapy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • 3.1.1-3.1.8.1 above
  • Underwent ablative therapies (SABR or surgery) for oligometastatic prostate cancer following radical prostatectomy and radiotherapy with biochemical response meeting criteria for either complete or partial biochemical response
  • Six months or more since last OM-directed ablative therapy.
  • Rising PSA as defined by PSA of nadir post ablative therapy + 2 ng/mL, or nadir post ablative therapy + 1 ng/mL in those where >12 months have elapsed since ablative therapy; in two repeated measures at least 2 weeks apart

排除标准

  • 未提供

研究组 & 干预措施

[18F] DCFPyL PET/MRI

Experimental

[18F] DCFPyL PET/MRI scans for patients with recurrent disease after radical prostatectomy and adjuvant/salvage radiotherapy.

Lesions identified through [18F] DCFPyL PET/MRI will be treated with stereotactic ablative radiotherapy (SABR) or surgery.

干预措施: [18F]DCFPyL PET/MRI scan (Diagnostic Test)

[18F] DCFPyL PET/MRI

Experimental

[18F] DCFPyL PET/MRI scans for patients with recurrent disease after radical prostatectomy and adjuvant/salvage radiotherapy.

Lesions identified through [18F] DCFPyL PET/MRI will be treated with stereotactic ablative radiotherapy (SABR) or surgery.

干预措施: Stereotactic Ablative Radiotherapy (Radiation)

结局指标

主要结局

To determine if [18F]DCFPyL PET-MR/CT can identify early oligometastatic disease in patients with a rising PSA and negative staging (CS and BS) after standard-of-care maximal local therapies.

时间窗: 3 years

Endpoint: Detection rates and performance metrics of \[18F\]DCFPyL PET-MR/CT in the post-prostatectomy plus adjuvant/salvage RT setting.

To determine if treating PET-MR/CT identified lesions with curative-intent treatment (e.g. stereotactic body radiation therapy or surgery) associated with favorable preliminary measures of clinical performance.

时间窗: 3 Years

* Proportion of patients achieving biochemical response: detectable PSA (\<0.05ng/mL) in 2 consecutive measurements (at least 2 weeks apart) within 6 months of treatment); or \> 50% PSA decline in 2 separate measurements at least 1 month apart within 6 months of treatment * Metabolic \[18F\]DCFPyL response rate after treatment * Treatment-related toxicities incidence as defined by CTCAE v4.0 * Time to initiation of salvage ADT after treatment

次要结局

  • Correlation between PSA kinetics and PET imaging parameters(6 months post SABR)
  • Correlate between tissue biomarker and distant disease(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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