Skip to main content
OpenTrials
Completed

NCT Number: NCT03160794

Prostate Cancer Subclinical Metastatic Ablative MR-guided Radiotherapy

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

3.1.1 - Age ≥ 18 years 3.1.2 - ECOG performance status of 0-2 3.1.3 - Absence of significant comorbidities rendering patient nor suitable for curative ablative approaches 3.1.4 - No history of active non-skin malignancy precluding management of their prostate cancer 3.1.5 - Histological evidence of prostate adenocarcinoma on previous radical prostatectomy.

3.1.6 - No use of any form of hormonal therapy in the previous 12 months, or intention to start HT at time of enrollment; and no use of ADT as salvage therapy.

3.1.7 - Normal serum testosterone level ascertained within 4-6 weeks of enrollment, as deemed by treating physician 3.1.8 - Absence of known metastatic disease on conventional imaging 3.1.8.1 - Radiological studies without evidence of regional or distant metastases: CT abdomen-pelvis and bone scan within previous 6 months (prior to PSMA PET scan or consent) or at discretion of the treating physician 3.1.8.2 - Patients with disease detected on PSMA PET-CT, performed at UHN as part of the Provincial or Institutional registry with disease amenable to SABR or surgery 3.1.9 - No contraindications to CT or PET as per Joint Department of Medical Imaging policies 3.1.10 - Able to lie supine at least 60 minutes to comply with imaging and treatment.

3.1.11 - Absence of impaired renal function (calculated GFR > 30mL/min) 3.1.12 - Absence of sickle cell disease or other hemoglobinopathies 3.1.13 - No other medical conditions deemed by the PI to make patient ineligible for PET/MR scanning or treatment (SABR or surgery) 3.1.14 Rising PSA after maximal local therapies (radical prostatectomy and either adjuvant or salvage radiotherapy): 3.1.14.1.1 - Three documented PSA rises, at least 1 month apart from post radiotherapy.

3.1.14.1.2 - PSA value >0.1 and < 3 ng/mL, within 4-6 weeks of enrollment. Salvage ADT to be started when PSA reaches a value of 6.0 ng/mL or greater

For the OM^2 group:

  • Met inclusion criteria 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

Treatment and study plan

[18F]DCFPyL PET/MRI scan

Diagnostic Test

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

stereotactic ablative radiotherapy

Radiation

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

Primary outcomes

  1. 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.

  2. 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

  1. Correlation between PSA kinetics and PET imaging parameters

    Time frame: 6 months post SABR

    To explore the correlation between PSA kinetics and PET imaging parameters (SUV, dynamic data, volumetric studies)

  2. Correlate between tissue biomarker and distant disease

    Time frame: 3 years

    To explore the correlation between tissue biomarkers from prostatectomy specimen (e.g. genomic signatures) and [18F]DCFPyL PET/MR-detected distant disease

Other outcomes

  1. [18F]DCFPyL PET/MR and PET/CT comparison

    Time frame: 3 years

    To determine concordance and compare performance between [18F]DCFPyL PET/MR and PET/CT

  2. Concordance of PET-MR/CT finding and histological confirmation of metastatic foci.

    Time frame: 3 years

    To determine the concordance of PET-MR/CT findings and histological confirmation of metastatic foci.

  3. Biomarker correlates

    Time frame: 3 years

    To explore blood, urine and tissue biomarker correlates of imaging features and radiotherapy tumour resposnse.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: PSMA MRgRT

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
May 19, 2017
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.