NCT04854369

68Ga-PSMA-11 Patients With Newly Diagnosed and Recurrent Prostate Cancer (Firefly)

68Ga-PSMA-11 Patients With Newly Diagnosed and Recurrent Prostate Cancer

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Tulane University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: —

Summary

This is a prospective, Phase 2, single-center, open-label study of 68Ga-PSMA-11 PET scans in patients with biochemically recurrent prostate cancer or those diagnosed and untreated with high risk or very high risk localized prostate cancer, or oligometastatic (defined as three or fewer metastatic lesions on conventional imaging) prostate cancer (using NCCN classification for localized disease). Approximately 300 patients are planned for enrollment in this study, divided into two cohorts. Cohort A will be 225 patients in the recurrent setting. Cohort B will be 75 patients in the up-front newly diagnosed setting. After a screening period (6-week window), eligible patients will undergo baseline assessments as per the Schedule of Study Activities. Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging study.

Conditions

• Prostatic Neoplasms
• Prostatic Neoplasms, Castration-Resistant

Interventions

Type	Name	Description
DRUG	68 Ga-PSMA-11 prepared using a PSMA-11 Sterile Cold Kit	The PSMA-11 Sterile Cold Kit is supplied as a kit for preparation of radiolabeled Gallium-68 PSMA-11 Injection, with 3 configurations (A, B or D) to accommodate the specificities of the 68Ge/68Ga generator that is used.

Timeline

• First posted: 2021-04-22
• Last updated: 2023-04-11

Locations

1 site across 1 country: United States