Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy

Adenocarcinoma of the Prostate Clinical Trial

Official title:

Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02523924
• Other study ID #: J1545
• Secondary ID: IRB00062296
• Status: Completed
• Phase: N/A
• Start date: June 2, 2015
• Est. completion date: March 4, 2019

Study information

• Verified date: January 2020
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot study aims to investigate the diagnostic utility of 18F-DCFPyL, a novel low-molecular weight PSMA PET/CT imaging agent, in men with an elevated PSA following radical prostatectomy.

Description:

18F-DCFPyL is a novel low-molecular weight PSMA imaging agent. A recent study of patients with metastatic prostate cancer found that PSMA PET/CT identified more sites of disease than conventional imaging with CT, MRI and bone scan. In this study we aim to investigate 18F-DCFPyL PET/CT in patients with an elevated PSA following radical prostatectomy. During the course of this study, patients will undergo two 18F-DCPyL PET/CT scans. The first scan will take place within 45 days of staging imaging and the second will take place following six months of standard of care therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 4, 2019
• Est. primary completion date: November 4, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age =18 years

• History of adenocarcinoma of the prostate treated with radical prostatectomy

• Serum PSA level =0.2 ng/mL at least 45 days prior to study enrollment

• Completed staging evaluation with bone scan as well as CT or MRI of the abdomen and pelvis at least 45 days prior to study enrollment

Exclusion Criteria:

• Intention to enroll in a blinded therapeutic clinical trial

• History of other malignancy diagnosed within the last three years (the exception of squamous cell or basal cell carcinoma of the skin)

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate

Intervention

Drug:
• 18F-DCFPyL
18F-DCFPyL PET/CT

Locations

Country	Name	City	State
United States	SKCCC	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation of 18F-DCFPyL PET/CT Findings With Time to Disease Progression		6 months
Other	Assessment of Treatment Response by 18F-DCFPyL PET/CT		6 months
Primary	Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT	Number of sites with 18F-DCFPyL uptake consistent with prostate cancer.	6 months
Primary	Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT	Location of uptake of 18F-DCFPyL consistent with prostate cancer.	6 months
Secondary	Correlation of 18F-DCFPyL PET/CT Findings With Prostate Specific Antigen (PSA) Levels	Number of participants with PSA 0.2-1.0ng/mL OR PSA >1.0ng/mL with at least 1 site of uptake of 18F-DCFPyL consistent with prostate cancer.	6 months
Secondary	Correlation of Findings on 18FDCFPyL PET/CT With Those Found on Conventional Imaging (Bone Scan and Cross-sectional Imaging)	Number of sites with uptake on 18F-DCFPyL PET/CT and corresponding lesions identified on conventional imaging.	6 months
Secondary	Correlation of Findings on 18F-DCFPyL PET/CT With Tissue Histology and PSMA Expression of Biopsied/Resected Pathology Specimens	Number of sites with 18F-DCFPyL uptake from which biopsy specimens show PSMA expression.	6 months