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Clinical Trial · NCT04775602
Experimental Study to Evaluate the Impact of 18 Fluoro-PSMA (18F-PSMA) PET / CT in the Management of Patients with Prostate Cancer.
Overview
Single-center, prospective, open-label, not randomized, diagnostic phase II trial in the management of patients with prostate cancer.
Sponsor
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Phase
Phase 2
Contacts
Federica Matteucci, MD (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT04775602Drug / Compound
PSMA
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- PSMA
Ligand Class: Small Molecules
Eligibility
Inclusion
- Previous radical treatment for prostate cancer (radiotherapy or surgery)
- Male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
- Patients with PSA progression defined as PSA ≥ 0.2 ng/mL and PSA rising defined as 2 subsequent values showing PSA increase at least 1 week apart.
- Patients must have histologically or cytologically confirmed prostate cancer
- Negativity of all the other traditional morphological and functional imaging or doubtful imaging of 18F-FMC PET/CT
Exclusion
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Study Agent.
- No radiotherapy in the last 6 months.
- Hormonotherapy in the last 6 months
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