RecruitingNot ApplicableNCT03160794

Prostate Cancer Subclinical Metastatic Ablative MR-guided Radiotherapy

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


Sponsor

University Health Network, Toronto

Enrollment

100 participants

Start Date

May 23, 2017

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a precise form of radiation therapy guided by MRI scans to treat small areas of prostate cancer spread that are not yet visible on standard imaging, in men whose prostate cancer has returned after surgery. **You may be eligible if...** - You previously had your prostate removed and the cancer was confirmed by tissue examination - Your cancer has returned (rising PSA) but scans show no obvious spread - You are in generally good health and able to carry out daily activities - You have not used hormone therapy in the past 12 months - You have normal testosterone levels - You have no known cancer spread to other parts of the body **You may NOT be eligible if...** - You have a history of other cancers (besides skin cancer) - You have significant other health conditions that make curative treatment unsuitable - Scans show cancer has spread to lymph nodes or distant organs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TEST[18F]DCFPyL PET/MRI scan

PET/MRI imaging using the radiotracer, \[18F\]DCFPyL

RADIATIONStereotactic Ablative Radiotherapy

SABR as treatment for lesions identified using \[18F\]DCFPyL PET/MRI


Locations(1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

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NCT03160794