How many clinical trials are studying Flotufolastat F-18 Gallium?

6 recruiting trials in our tracked data involve Flotufolastat F-18 Gallium.

What conditions is Flotufolastat F-18 Gallium being studied for?

In our tracked recruiting trials, Flotufolastat F-18 Gallium is being studied in trials for Prostate cancer, Prostate Adenocarcinoma, Prostate Carcinoma.

Flotufolastat F-18 Gallium: clinical trials recruiting now

Q: Is Flotufolastat F-18 Gallium FDA-approved?

Yes. According to the FDA drug label available through openFDA, Flotufolastat F-18 Gallium is an FDA-approved drug.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Flotufolastat F-18 Gallium appears in the FDA drug-label database. Marketed as POSLUMA.
Drug class: Radioactive Diagnostic Agent (FDA established pharmacologic class)
Mechanism of action: Positron Emitting Activity (as stated on the FDA label)

FDA-approved use

POSLUMA is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. POSLUMA is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. ( 1 )

FDA label via openFDA

Phase breakdown

Early Phase 1 3 Phase 2 2 Not applicable 1

Conditions being studied

Condition	Trials
Prostate cancer · Flotufolastat F-18 Gallium for Prostate cancer	6
Prostate Adenocarcinoma · Flotufolastat F-18 Gallium for Prostate Adenocarcinoma	3
Prostate Carcinoma	2
Stage I Prostate Cancer AJCC v8	2
Stage III Prostate Cancer AJCC v8	2
Biochemically Recurrent Prostate Carcinoma	1
Localized Prostate Carcinoma	1
Oligometastatic Prostate Carcinoma	1
Stage II Prostate Cancer AJCC v8	1
Stage IIA Prostate Cancer AJCC v8	1
Stage IIB Prostate Cancer AJCC v8	1
Stage IIC Prostate Cancer AJCC v8	1
Stage IV Prostate Cancer AJCC v8	1
Stage IVA Prostate Cancer AJCC v8	1

Recruiting trials involving Flotufolastat F-18 Gallium

Accuracy of 18F-rhPSMA-7.3 PET/ MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer
NCT06389786 · Phase: Not applicable (e.g. observational or device study) · Ages: 30 Years to 85 Years · Sex: Male · 1 location
An Investigational Scan (18F-rhPSMA-7.3 PET-mpMRI) for Targeted Prostate Biopsy Using TRUS-MR Fusion Technique
NCT06865768 · Phase: Phase 2 · Ages: 18 Years and older · Sex: Male · 1 location
An Investigational Scan (rhPSMA-7.3 PET/CT) for Detecting Biochemically Recurrent Prostate Cancer, ENLIGHTEN Trial
NCT06813898 · Phase: Early Phase 1 · Ages: No age limits stated · Sex: Male · 1 location
Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With High Risk or Very High Risk Prostate Cancer, The EnrichPSMA Trial
NCT07025369 · Phase: Phase 2 · Ages: 18 Years and older · Sex: Male · 1 location
Comparing a New PSMA Imaging Agent to MRI for Detecting Prostate Cancer, BEACON Trial
NCT07164027 · Phase: Early Phase 1 · Ages: 18 Years to 90 Years · Sex: Male · 1 location
rhPSMA-73 PET-MRI Imaging for the Detection of Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance
NCT05852041 · Phase: Early Phase 1 · Ages: 18 Years and older · Sex: Male · 1 location

Common questions

Is Flotufolastat F-18 Gallium FDA-approved?

Yes, marketed as POSLUMA.

How many recruiting trials involve Flotufolastat F-18 Gallium?

6 recruiting trials across 14 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.