Study of the Clinical Utility of PSMA Imaging in the Evaluation of Men With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Study of the Clinical Utility of PSMA Imaging in the Evaluation of Men With Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825875
• Other study ID #: J15216
• Secondary ID: IRB00084971
• Status: Completed
• Start date: June 8, 2016
• Est. completion date: April 2020

Study information

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

Clinical Trial Summary

In this study we aim to more precisely define the clinical utility of PSMA imaging across a range of clinical indications in men with prostate cancer. To accomplish this, we will make the 18F-DCFPyL PET/CT scan available to urologists, medical oncologists, and radiation oncologists at Johns Hopkins and survey physicians as to the indication for ordering the PET/CT and if a change in management occurred as the result of new information gained from the scan. We believe these data will prove critical for planning future studies aimed at evaluating the efficacy of this test for improving patient outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Age =18 years

2. Willingness to signed informed consent

3. Histologically confirmed adenocarcinoma of the prostate

4. PSA measurement =60 days prior to study enrollment

5. Completed radiographic evaluation with whole-body bone scan (99mTc-MDP or Na18F) and cross-sectional imaging (CT or MRI) of the abdomen and pelvis =60 days prior to study enrollment

Exclusion Criteria:

1. Administered a radioisotope within 5 physical half-lives prior to study enrollment

2. History of other malignancy diagnosed within the last 5 years (exceptions: low grade urothelial carcinoma of the bladder, squamous cell carcinoma or basal cell carcinoma of the skin).

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 18F DCFPyL- Radiopharmaceutica

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Progenics Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physician responses to a questionnaire	The Post-PET/CT questionnaire will determine if the PET/CT scan results in changes to clinical management of patient illness.	less than 1 year