An Early Phase 1 interventional study of Pelvic DCFPyL PET-MRI fusion or PET/MRI in Advanced Prostate Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Completed at 1 site in United States. Open to male participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-03-19.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Early Phase 1, Interventional, and Diagnostic
This research is being done to see if an investigational radioactive imaging agent (radiotracer) called 18F-DCFPyL can help us find prostate cancer at its original site in the prostate gland and in distant sites (bone, lymph nodes) in men diagnosed with prostate cancer before surgery.
The investigators propose to evaluate the feasibility of using a novel small molecule PET radiotracer, DCFPyL to target prostate cancer prostate-specific membrane antigen (PSMA). PSMA is a well studied cell surface marker of prostate cancer with increased expression associated with higher tumor grade and advanced metastatic tumors. More specifically it is associated with a higher Gleason score and there is evidence it can serve as a potential marker for prostate tumor carcinogenesis, progression and as a AR signaling surrogate marker of ADT response. This small molecule PET radiotracer specifically targeting an important prostate specific marker of AR signaling dynamics following ADT, tumor progression and metastatic potential warrants validation as an in-vivo non-invasive imaging biomarker for PSMA expression and prostate cancer detection.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 23 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 572 studies on the registry; 73 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 67 (60%) have results posted.
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Key inclusion criteria (the entire list of inclusion and exclusion criteria will appear later in section 4 of the protocol)
Exclusion Criteria:
* Pelvic DCFPyL PET-MRI fusion or PET/MRI compared before and after 2-3 months of ADT * Pelvic DCFPyL PET-MRI fusion or PET/MRI compared before and after 2-3 months
Drug: Pelvic DCFPyL PET-MRI fusion or PET/MRI
* Pelvic DCFPyL PET-MRI fusion or PET/MRI compared before and after 2-3 months of ADT * Pelvic DCFPyL PET-MRI fusion or PET/MRI compared before and after 2-3 months
Response rate differences
To compare the detection , sextant localization and response of DCFPyL PET-MRI fusion or PET/MRI before and after 2-3 months of ADT in men with biopsy-positive high-risk localized or locally advanced prostate cancer.
Time frame: baseline and after 2-3 months
Biomarker changes
To compare DCFPyL PET-MRI fusion or PET/MRI uptake in prostate cancer (quantified as per sextant SUVmax, SUVavg, metabolic tumor volume, total lesion DCFPyL uptake, DCFPyL uptake rate) as a reliable non-invasive imaging biomarker of PSMA expression following ADT as determined by qualitative and quantitative MRI-guided prostate biopsy core tissue immunohistochemical analysis. DCFPyL uptake will also be compared to other prostate cancer relevant marker expression levels (PSA, Ki-67, TMPRSS2-ERG) by immunohistochemical analysis.
Time frame: Baseline and at 2=3 months
Metabolic tumor uptake changes
To compare DCFPyL PET-MRI fusion or PET/MRI uptake in primary prostate cancer (quantified as per sextant SUVmax, SUVavg, metabolic tumor volume, total lesion DCFPyL uptake, DCFPyL uptake rate) following ADT with standard clinical prognostic markers (PSA, Gleason score, clinical stage) and with predictive model of pathologic stage.
Time frame: baseline and then at 2-3 months
Gene expression changes
To validate DCFPyL PET-MRI fusion or PET/MRI uptake in prostate cancer (quantified as per sextant SUVmax, SUVavg, metabolic tumor volume, total lesion DCFPyL uptake, DCFPyL uptake rate) as a reliable non-invasive imaging biomarker of AR signaling following ADT as determined by AR gene set expression of biopsy core tissue specimens using qPCR.
Time frame: Baseline and then at 2-3 months
Nodal metastatic disease changes
To compare the detection of nodal metastatic disease by DCFPyL PET-MRI fusion or PET/MRI at initial staging to detection by available conventional imaging modalities (bone scan, CT, MRI) and when available biopsy pathology.
Time frame: Baseline and then at 2-3 months
All cause DCFPyL PET-MRI fusion or PET/MRI toxicity
To determine the safety of DCFPyL.
Time frame: Baseline and then at 2-3 months
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins