Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02523924|
Recruitment Status : Completed
First Posted : August 14, 2015
Results First Posted : January 31, 2020
Last Update Posted : January 31, 2020
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Prostate||Drug: 18F-DCFPyL||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy|
|Actual Study Start Date :||June 2, 2015|
|Actual Primary Completion Date :||November 4, 2016|
|Actual Study Completion Date :||March 4, 2019|
Experimental: 18F-DCFPyL PET/CT
Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT
- Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT [ Time Frame: 6 months ]Number of sites with 18F-DCFPyL uptake consistent with prostate cancer.
- Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT [ Time Frame: 6 months ]Location of uptake of 18F-DCFPyL consistent with prostate cancer.
- Correlation of 18F-DCFPyL PET/CT Findings With Prostate Specific Antigen (PSA) Levels [ Time Frame: 6 months ]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.
- Correlation of Findings on 18FDCFPyL PET/CT With Those Found on Conventional Imaging (Bone Scan and Cross-sectional Imaging) [ Time Frame: 6 months ]Number of sites with uptake on 18F-DCFPyL PET/CT and corresponding lesions identified on conventional imaging.
- Correlation of Findings on 18F-DCFPyL PET/CT With Tissue Histology and PSMA Expression of Biopsied/Resected Pathology Specimens [ Time Frame: 6 months ]Number of sites with 18F-DCFPyL uptake from which biopsy specimens show PSMA expression.
- Correlation of 18F-DCFPyL PET/CT Findings With Time to Disease Progression [ Time Frame: 6 months ]
- Assessment of Treatment Response by 18F-DCFPyL PET/CT [ Time Frame: 6 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 100 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- 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
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02523924
|United States, Maryland|
|Baltimore, Maryland, United States, 21287|
Documents provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
|Responsible Party:||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Other Study ID Numbers:||
IRB00062296 ( Other Identifier: JHMIRB )
|First Posted:||August 14, 2015 Key Record Dates|
|Results First Posted:||January 31, 2020|
|Last Update Posted:||January 31, 2020|
|Last Verified:||January 2020|
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type