Prostate Cancer Subclinical Metastatic Ablative MR-guided Radiotherapy

Not Applicable

Recruiting

• Conditions: Post Prostatectomy
• Interventions: Diagnostic Test: [18F]DCFPyL PET/MRI scan; Radiation: Stereotactic Ablative Radiotherapy

• Registration Number: NCT03160794
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-18
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-19
• Study Start: 2017-05-23
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[18F] DCFPyL PET/MRI	[18F]DCFPyL PET/MRI scan	\[18F\] DCFPyL PET/MRI scans for patients with recurrent disease after radical prostatectomy and adjuvant/salvage radiotherapy. Lesions identified through \[18F\] DCFPyL PET/MRI will be treated with stereotactic ablative radiotherapy (SABR) or surgery.
[18F] DCFPyL PET/MRI	Stereotactic Ablative Radiotherapy	\[18F\] DCFPyL PET/MRI scans for patients with recurrent disease after radical prostatectomy and adjuvant/salvage radiotherapy. Lesions identified through \[18F\] DCFPyL PET/MRI will be treated with stereotactic ablative radiotherapy (SABR) or surgery.

Primary Outcome Measures

Name	Time	Method
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 years	Endpoint: 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 Outcome Measures

Name	Time	Method
Correlation between PSA kinetics and PET imaging parameters	6 months post SABR	To explore the correlation between PSA kinetics and PET imaging parameters (SUV, dynamic data, volumetric studies)
Correlate between tissue biomarker and distant disease	3 years	To explore the correlation between tissue biomarkers from prostatectomy specimen (e.g. genomic signatures) and \[18F\]DCFPyL PET/MR-detected distant disease

Trial Locations

Locations (1)

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada