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

Status:

NO_LONGER_AVAILABLE

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

Lead Sponsor:

Tulane University

Conditions:

Prostatic Neoplasms

Prostatic Neoplasms, Castration-Resistant

Eligibility:

MALE

18+ years

Brief 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 ve...

Eligibility Criteria

Inclusion

Males greater than 18 years of age.
Histologically proven adenocarcinoma of the prostate. Diagnosis must be stated in a pathology report and confirmed by the investigator.
Patients must meet the criteria of one of the following cohorts:
Cohort A: (n=225) Biochemical recurrence; defined as any of the following:
PSA ≥ 0.2 ng/mL and rising in at least two consecutive tests (at least one week apart) within 6 months of date of consent for patients treated with radical prostatectomy.
PSA \>2.0 ng/mL above the nadir and rising post-radiation (external beam or brachytherapy) +/- hormones, in at least 2 consecutive tests (at least one week apart) within 6 months of consent
In patients with no prior definitive surgery or radiation, PSA ≥ 2 ng/mL greater than the post therapy nadir after androgen deprivation therapy.
Note: Patients whom have had more than one prior therapy, should be defined recurrent by their most recent therapy type. For patients who have had any ADT, are mCRPC, shall fall into that category for allocation and eligibility.
Cohort B: (n=75) No prior treatment defined as one of the following:
o Patient has primary diagnosis of "high risk" or "very high risk" localized prostate cancer, or regional prostate cancer (TxN1M0) or oligometastatic cancer (TxNXM1) with less than three metastatic lesions by conventional imaging) and has not received prior treatment.
Note: high risk/very high risk is denoted by Gleason 8-10, or PSA \>20, or clinical stage T3a/T4 disease (see NCCN guidelines v1.2020).
Patients in this cohort must be considered candidates for initial definitive therapy at the time of study enrollment.
Life expectancy of \>6 months
Patients should have a Comprehensive Metabolic Panel, PSA, and Testosterone drawn within 4 weeks of imaging

Exclusion

Claustrophobia or any other condition that would preclude PET/CT imaging.
Patients with known metastatic prostate cancer, with 4 or more lesions on conventional imaging

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04854369

Last Update

April 11 2023

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