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Test-Retest Reproducibility of 18F-DCFPyL PET/CT in the Evaluation of Patients With Metastatic Prostate Cancer

NCT ID: NCT03793543

Last Updated: 2021-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-27

Study Completion Date

2021-10-15

Brief Summary

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In this study, the investigators intend to validate 18F-DCFPyL test-retest reproducibility in metastatic lesions, in order to investigate whether it serves as a reliable response assessment tool, both to interpret existing studies and to design future longitudinal trials.

Detailed Description

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The investigators will image patients with widely metastatic castration-sensitive (CSPC) or castration-resistant prostate cancer (CRPC) using 18F-DCFPyL-PET/CT for detection of tumor burden and perform a lesion-based head-to-head comparison with a subsequent near-term (one to seven days) 18F-DCFPyL-PET/CT follow-up scan, to assess test-retest reproducibility of this second-generation PSMA-targeted compound. Second, as it has not been specifically investigated with this compound before, intra-observer agreement as well as inter-scan variability will be assessed.

Conditions

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Prostate Cancer

Keywords

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J18127 PSMA PyL 18F-DCFPyL PET/CT

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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18F-DCFPyL Injection

9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL

Group Type EXPERIMENTAL

18F-DCFPyL Injection

Intervention Type DRUG

A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL

Interventions

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18F-DCFPyL Injection

A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Willing and able to provide written informed consent
* History of histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
* Patients with metastatic castration-sensitive (CSPC) or castration-resistant prostate cancer (CRPC) with evidence of metastatic disease on conventional imaging with CT or bone scan.
* Prior docetaxel-based chemotherapy is permitted
* Documented metastatic prostate cancer progression as assessed by the treating oncologist with either one or both of the following and has not initiated a new therapy after determination of progression: Rising PSA over a minimum 1-week interval and/or radiographic progression in soft tissue and bone metastases (combination of bony and soft tissue metastases)
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Exclusion Criteria

* Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
* Administered a radioisotope ≤5 physical half-lives prior to the date of study PET/CT
* Administered IV X-ray contrast medium ≤24 hours prior to the date of study PET/CT
* Administered oral contrast medium ≤120 hours prior to the date of study PET/CT
* Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Rowe, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Werner RA, Lutje S, Habacha B, Bundschuh L, Higuchi T, Buck AK, Kosmala A, Lapa C, Essler M, Lodge MA, Pienta KJ, Eisenberger MA, Markowski MC, Gorin MA, Pomper MG, Rowe SP, Bundschuh RA. Test-retest repeatability of organ uptake on PSMA-targeted 18 F-DCFPyL PET/CT in patients with prostate cancer. Prostate. 2023 Sep;83(12):1186-1192. doi: 10.1002/pros.24577. Epub 2023 May 21.

Reference Type DERIVED
PMID: 37211963 (View on PubMed)

Werner RA, Habacha B, Lutje S, Bundschuh L, Higuchi T, Hartrampf P, Serfling SE, Derlin T, Lapa C, Buck AK, Essler M, Pienta KJ, Eisenberger MA, Markowski MC, Shinehouse L, AbdAllah R, Salavati A, Lodge MA, Pomper MG, Gorin MA, Bundschuh RA, Rowe SP. High SUVs Have More Robust Repeatability in Patients with Metastatic Prostate Cancer: Results from a Prospective Test-Retest Cohort Imaged with 18F-DCFPyL. Mol Imaging. 2022 Feb 23;2022:7056983. doi: 10.1155/2022/7056983. eCollection 2022.

Reference Type DERIVED
PMID: 35283693 (View on PubMed)

Other Identifiers

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IRB00174393

Identifier Type: OTHER

Identifier Source: secondary_id

J18127

Identifier Type: -

Identifier Source: org_study_id