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

NCT ID: NCT02420977

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-06
• Study Completion Date: 2025-03-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Pelvic DCFPyL PET-MRI fusion or PET/MRI

Intervention Type: DRUG

• 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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Men 18 years of age or greater with recently diagnosed prostate cancer with planned radiation and ADT.

• Newly diagnosed prostate cancer pathologically proven by prostate biopsy
• Prostate biopsy histology grade ≥ Gleason 8-10
• Patients considered as candidates for and medically fit to undergo radiation and ADT
• At least 10 days after most recent prostate biopsy

Exclusion Criteria

• Prior pelvic external beam radiation therapy or brachytherapy
• Chemotherapy for prostate cancer
• Hormone deprivation therapy
• Investigational therapy for prostate cancer
• Hemorrhagic cystitis or active prostatitis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Curtiland Deville, M.D.

Role: PRINCIPAL_INVESTIGATOR

The SKCCC at Johns Hopkins

Locations

Curtiland Deville

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00065395

Identifier Type: OTHER

Identifier Source: secondary_id

1U01CA183031-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

J1560

Identifier Type: -

Identifier Source: org_study_id