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Study of 18F-DCFPyL, a Second Generation Low-molecular Weight PSMA-based PET Radiotracer, in Patients With Prostate Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study of 18F-DCFPyL, a Second Generation Low-molecular Weight PSMA-based PET Radiotracer, in Patients With Prostate Cancer

NCT02151760•Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

View on ClinicalTrials.gov

Summary

This study is being done to determine the safety, biodistribution, and radiation dosimetry of 18F-DCFPyL, and to detect prostate cancer by visual analysis.

Detailed Description

To assess the hypothesis that this new 2nd generation positron emission tomography (PET) radiopharmaceutical, 18F-DCFPyL, may possess pharmacokinetic and pharmacodynamic properties that will represent an advance in imaging metastatic prostate cancer in ten patients diagnosed with metastatic prostate cancer.

Eligibility

Age

18 - 100 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Greater than or equal to 18 years of age
•2. Histological confirmation of prostate cancer
•3. Radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, 18F-Sodium Fluoride PET, or 18F-FDG PET
•4. PSA ≥ 1.0 ng/mL
•5. Can be on androgen deprivation therapy if dose is stable for ≥ 1 week.
•6. Platelet count \> 50,000/mm3
•7. Neutrophil count \> 1,000/mm3
•8. Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits.
•9. Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.

Exclusion Criteria

•Patients will be excluded from enrollment if any of the following apply:
•1. Karnovsky performance status of \< 60
•2. Inadequate venous access (two antecubital or equivalent venous access sites are required for study drug injection and PK blood sampling, respectively)
•3. Patient received a permanent prostate brachytherapy implant within the last 3 months (for Pd-103 implants) or 12 months (for I-125 implants)
•4. Administered a radioisotope within 5 physical half-lives prior to study enrollment
•5. Serum creatinine \> 3 times the upper limit of normal
•6. Total bilirubin \> 3 times the upper limit of normal
•7. Liver Transaminases \> 5times the upper limit of normal
•8. Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 30 days prior to study radiotracer administration
•9. Prior radiation therapy or chemotherapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest).
+1 more criteria

Locations (1)

Johns Hopkins University

Baltimore, Maryland, United States

Key Dates

Start Date

May 1, 2014

Primary Completion Date

April 1, 2020

Completion Date

April 1, 2020

Last Updated

May 7, 2020

Enrollment

ACTUAL participants

Conditions

Metastatic Prostate Cancer

Interventions

18F-DCFPyL

DRUG

Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer

NCT07181161

Metastatic Prostate Cancer

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RECRUITINGPHASE2

Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer

NCT06616597

Prostate Cancer (Adenocarcinoma)Metastatic Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 7, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of 18F-DCFPyL, a Second Generation Low-molecular Weight PSMA-based PET Radiotracer, in Patients With Prostate Cancer

Inclusion Criteria

Exclusion Criteria

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Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer

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