Overview

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

Status:
Recruiting
Trial end date:
2024-01-01
Target enrollment:
0
Participant gender:
Male
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Criteria
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