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Clinical Trials/NCT03160794
NCT03160794
Recruiting
Not Applicable

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

University Health Network, Toronto1 site in 1 country100 target enrollmentMay 23, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post Prostatectomy
Sponsor
University Health Network, Toronto
Enrollment
100
Locations
1
Primary Endpoint
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.
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 23, 2017
End Date
September 2027
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Time Frame: 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.

Time Frame: 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

Secondary Outcomes

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

Study Sites (1)

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