Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
NCT Number: NCT03160794
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.
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Notify Me18 year and older
Male
Interventional
Not applicable
Toronto, Ontario, M5G 2M9, Canada
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:
PET/MRI imaging using the radiotracer, [18F]DCFPyL
SABR as treatment for lesions identified using [18F]DCFPyL PET/MRI
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.
Time frame: 3 Years
Time frame: 6 months post SABR
To explore the correlation between PSA kinetics and PET imaging parameters (SUV, dynamic data, volumetric studies)
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
Time frame: 3 years
To determine concordance and compare performance between [18F]DCFPyL PET/MR and PET/CT
Time frame: 3 years
To determine the concordance of PET-MR/CT findings and histological confirmation of metastatic foci.
Time frame: 3 years
To explore blood, urine and tissue biomarker correlates of imaging features and radiotherapy tumour resposnse.
University Health Network, Toronto
Other
Phase II Study: [18F]DCFPyL PET/MRI for Personalizing Prostate Cancer Subclinical Metastatic Ablative MR-guided Radiotherapy (MRgRT)
Acronym: PSMA MRgRT
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.
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