Skip to content

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)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03160794
Acronym
PSMA MRgRT
Enrollment
150
Registered
2017-05-19
Start date
2017-05-23
Completion date
2025-04-01
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Prostatectomy

Keywords

Prostate cancer, stereotactic ablative radiotherpy, PET/MR

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.

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

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
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.3 yearsEndpoint: 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.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

MeasureTime frameDescription
Correlation between PSA kinetics and PET imaging parameters6 months post SABRTo explore the correlation between PSA kinetics and PET imaging parameters (SUV, dynamic data, volumetric studies)
Correlate between tissue biomarker and distant disease3 yearsTo explore the correlation between tissue biomarkers from prostatectomy specimen (e.g. genomic signatures) and \[18F\]DCFPyL PET/MR-detected distant disease

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORAlejandro Berlin, MD

Princess Margaret Cancer Centre - University Health Network

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026