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F18 DCFPyL PET/CT in Imaging Participants With Recurrent Prostate Cancer

18F-DCFPyL PET/CT in the Evaluation of Patients With Biochemical Recurrence of Prostate Cancer and Non-Contributory CT Scans

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT03501940
Enrollment
Unknown
Registered
2018-04-18
Start date
Unknown
Completion date
Unknown
Last updated
2022-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Adenocarcinoma, PSA Level Greater Than 0.2, PSA Level Greater Than or Equal to Two, PSA Progression, Recurrent Prostate Carcinoma

Brief summary

This study provides fluorine F 18 DCFPyL positron emission tomography/computed tomography (PET/CT) to participants with prostate cancer that has come back. Diagnostic procedures, such as fluorine F 18 DCFPyL PET/CT, may help find and diagnose prostate cancer and find out how far the disease has spread.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate fluorine F 18 DCFPyL (18F-DCFPyL) PET/CT for detection of recurrent prostate cancer after initial therapy in patients with elevated prostate-specific antigen (PSA). OUTLINE: Participants receive fluorine F 18 DCFPyL intravenously (IV). After 60-120 minutes, participants undergo whole body PET/CT. Immediately after the first scan, participants may undergo a second PET/CT without receiving fluorine F 18 DCFPyL. After completion of study, participants are followed up at 24-72 hours.

Interventions

PROCEDUREComputed Tomography

Undergo 18F-DCFPyL PET/CT

Given IV

OTHERLaboratory Biomarker Analysis

Correlative studies

PROCEDUREPositron Emission Tomography

Undergo 18F-DCFPyL PET/CT

Sponsors

Andrei Iagaru
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Biopsy proven prostate adenocarcinoma * Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy) * Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation * PSA greater than 0.2 ng/mL measured after at least 6 weeks from radical prostatectomy * Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL) * Post-radiation therapy - American Society for Radiation Oncology (ASTRO) - Phoenix consensus definition * A rise of PSA measurement of 2 or more ng/mL over the nadir * Able to provide written consent * Karnofsky performance status of \> 50 (or Eastern Cooperative Oncology Group \[ECOG\] / World Health Organization \[WHO\] equivalent)

Exclusion criteria

* Unable to provide informed consent * Inability to lie still for the entire imaging time * Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.) * Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026