Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT03160794

Prostate Cancer Subclinical Metastatic Ablative MR-guided Radiotherapy

Led by University Health Network, Toronto · Updated on 2025-02-10

100

Participants Needed

1

Research Sites

536 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Prostate Cancer Subclinical Metastatic Ablative MR-guided Radiotherapy

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • ECOG performance status of 0-2
  • No significant other illnesses preventing curative ablative treatment
  • No history of non-skin cancer
  • Confirmed prostate adenocarcinoma from previous prostatectomy
  • No hormonal therapy use in past 12 months or planned at enrollment
  • Normal testosterone level within 4-6 weeks before enrollment
  • No known metastatic disease
  • CT abdomen-pelvis and bone scan within 3 months showing no metastases
  • Able to lie on back for at least 60 minutes
  • Kidney function with GFR above 30 mL/min
  • No sickle cell disease or related blood disorders
  • No conditions making patient unsuitable for PET/MR or SABR
  • Weight under 136 kg (MRI scanner limit)
  • No pacemakers, aneurysm clips, shrapnel, or incompatible implants
  • No prior severe allergic reaction to gadolinium
  • Rising PSA after maximal local therapies with three documented rises
  • PSA value between 0.1 and less than 3 ng/mL within 4-6 weeks before enrollment
  • No androgen deprivation therapy in past 12 months and not planned
  • Salvage ADT to start if PSA reaches 6.0 ng/mL or higher
Not Eligible

You will not qualify if you...

  • Significant comorbidities making curative therapy unsafe
  • History of non-skin malignancy
  • Known metastatic disease
  • Evidence of metastases on recent CT or bone scans
  • Inability to lie supine for at least 60 minutes
  • Impaired renal function (GFR 30 mL/min or below)
  • Sickle cell disease or other hemoglobinopathies
  • Contraindications to MRI including weight over 136 kg, incompatible implants, or prior anaphylaxis to gadolinium
  • Use or planned use of hormonal therapy within 12 months before enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

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Research Team

A

Alejandro Berlin, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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