NCT02420977

Evaluation of PSMA-based PET as an Imaging Biomarker in Prostate Cancer

Evaluation of PSMA-based PET as an Imaging Biomarker of Androgen Receptor Signaling in High-Risk Localized and Locally Advanced Prostate Cancer

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Male
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Advanced Prostate Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-12-06
• Primary completion: 2024-03-01
• Completion: 2025-03-01
• First posted: 2015-04-20
• Last updated: 2025-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study