Head-to-head Comparison of [18F]AlF-PSMA-N5 With [18F]F-DCFPyL PET/CT in PCa Diagnosis, Recurrence, and Metastasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [18F]AlF-PSMA-N5, [18F]F-DCFPyL.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, PET/CT. Basic parameters: 18 years — 90 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Head-to-head Comparison of [18F]AlF-PSMA-N5 With [18F]F-DCFPyL PET/CT in Prostate Cancer Diagnosis, Recurrence, and Metastasis: a Prospective Study
Overview
To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent \[18F\]AlF-PSMA-N5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with \[18F\]F-DCFPyL.
Detailed description
\[18F\]AlF-PSMA-N5 PET/CT was used for initial assessment of prostate cancer or detection of recurrence. The maximum standardized uptake value (SUVmax) was used to evaluate tumor uptake. The sensitivity, specificity, the number and accuracy of lesions identified and the distribution of lesions in each organ were calculated and compared with those of \[18F\]F-DCFPyL PET/CT.
Interventions
- Drug [18F]AlF-PSMA-N5
Each subject receive a single intravenous injection of \[18F\]AlF-PSMA-N5, and undergo PET/CT imaging within the specificed time. - Drug [18F]F-DCFPyL
Each subject receive a single intravenous injection of \[18F\]F-DCFPyL, and undergo PET/CT imaging within the specificed time.
Primary outcome measures
- Standard uptake value(SUV) [Time frame: 30 days]
Secondary outcome measures (2)
- Diagnostic efficacy [Time frame: 30 days]
- Number of lesions [Time frame: 30 days]
Eligibility criteria
Inclusion criteria
- Aged from 18 to 90 years old;
- Complete MRI images and clinical data (such as PSA level, Gleason grade, etc.);
- Prostate cancer detected by PSA or imaging examination, or clinically suspected recurrence after standardized treatment;
- simultaneous \[18F\]AlF-PSMA-N5 and \[18F\]F-DCFPyL examinations within two weeks;
- Willing to undergo surgery or needle biopsy for pathological examination after examination, or confirmed as prostate cancer by histopathology before or after treatment;
- Sign informed consent.
Exclusion criteria
- Patients who cannot cooperate with the examination;
- Concurrent malignant tumors;
- Previous alcohol allergy;
- Patients with liver and kidney dysfunction;
- Other circumstances deemed by the investigator to be inappropriate for trial participation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- The First Affiliated Hospital of China University of Science and Technology（Anhui Provinci — Hefei
Identifiers
NCT: NCT06756334 · PSMA PET STUDY -03