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

NCT ID: NCT02151760

Last Updated: 2020-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2020-04-30

Brief 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.

Conditions

Metastatic Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

18F-DCFPyL

Group Type: EXPERIMENTAL

18F-DCFPyL

Intervention Type: DRUG

Interventions

18F-DCFPyL

Intervention Type: DRUG

Other Intervention Names

10.0 A bolus of less than or equal to 9 mCi (331 MBq) of 18F-DCFPyL will be injected into the IV line by slow push IV push.

Eligibility Criteria

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).

10. Prior history of any other malignancy within 3 years, other than skin basal cell carcinoma.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steve Y Cho, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00092956

Identifier Type: OTHER

Identifier Source: secondary_id

P50CA103175

Identifier Type: NIH

Identifier Source: secondary_id

View Link

J1418

Identifier Type: -

Identifier Source: org_study_id