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

Advanced Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02420977
• Other study ID #: J1560
• Secondary ID: IRB000653951U01C
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: December 6, 2018
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 23
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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

• Key inclusion criteria (the entire list of inclusion and exclusion criteria will appear later in section 4 of the protocol)

• 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

Related Conditions & MeSH terms

• Advanced Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Curtiland Deville	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and after 2-3 months
Secondary	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.	Baseline and at 2=3 months
Secondary	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.	baseline and then at 2-3 months
Secondary	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.	Baseline and then at 2-3 months
Secondary	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.	Baseline and then at 2-3 months
Secondary	All cause DCFPyL PET-MRI fusion or PET/MRI toxicity	To determine the safety of DCFPyL.	Baseline and then at 2-3 months