At a glance
ClinicalIndex Comparison Record- ✓Histological evidence of prostate adenocarcinoma on previous radical prostatectomy
- ✓Rising PSA after maximal local therapies (radical prostatectomy and adjuvant or salvage radiotherapy)
- ✓Three documented PSA rises at least 1 month apart from post radiotherapy
- ✓PSA value >0.1 and <3 ng/mL within 4-6 weeks of enrollment
- ✕History of non-skin malignancy
- ✕Use of any form of hormonal therapy in previous 12 months or intention to start at enrollment
- ✕Evidence of regional or distant metastases on imaging
- ✕Impaired renal function (GFR ≤30 mL/min)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study: [18F]DCFPyL PET/MRI for Personalizing Prostate Cancer Subclinical Metastatic Ablative MR-guided Radiotherapy (MRgRT)
In Brief
A clinical study evaluating [18F]DCFPyL PET/MRI scan and Stereotactic Ablative Radiotherapy for Post Prostatectomy. Completed, enrolled 150 participants across 1 site.
Detailed 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.
Study Details
Timeline
Arms & Interventions
\[18F\] 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.
Interventions
PET/MRI imaging using the radiotracer, \[18F\]DCFPyL
SABR as treatment for lesions identified using \[18F\]DCFPyL PET/MRI