Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy
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ClinicalTrials.gov Identifier: NCT02523924 |
Recruitment Status :
Active, not recruiting
First Posted : August 14, 2015
Last Update Posted : July 12, 2018
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Condition or disease | Intervention/treatment | Phase |
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Adenocarcinoma of the Prostate | Drug: 18F-DCFPyL | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
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 : | May 2015 |
Actual Primary Completion Date : | November 2016 |
Estimated Study Completion Date : | November 2019 |
Arm | Intervention/treatment |
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Experimental: 18F-DCFPyL PET/CT
Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT
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Drug: 18F-DCFPyL
18F-DCFPyL PET/CT |
- Description of putative sites of metastatic disease as determined by 18F-DCFPyL PET/CT [ Time Frame: 6 months ]
- Assessment of treatment response by 18F-DCFPyL PET/CT [ Time Frame: 6 months ]
- Correlation of 18F-DCFPyL PET/CT findings with PSA levels and time to disease progression [ Time Frame: 3 years ]

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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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)

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 | |
SKCCC | |
Baltimore, Maryland, United States, 21287 |
Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
ClinicalTrials.gov Identifier: | NCT02523924 History of Changes |
Other Study ID Numbers: |
J1545 IRB00062296 ( Other Identifier: JHMIRB ) |
First Posted: | August 14, 2015 Key Record Dates |
Last Update Posted: | July 12, 2018 |
Last Verified: | July 2018 |
Additional relevant MeSH terms:
Adenocarcinoma Prostatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases |