Clinical Trial · NCT02920229

68Ga-PSMA HBED-PET/CT in the Evaluation of the Biochemical Relapse in Patients With a History of Prostate Cancer Radically Treated

Overview

Single-center, prospective, diagnostic trial in radically treated patients with biochemical recurrence of prostate cancer. Patients with radically treated prostate cancer with biochemical relapse and negativity of all traditional morphological and functional imaging (transrectal ultrasound, bone scan, 18F-FMC PET/CT, CT/MRI) or doubtful imaging of 2-deoxy-2-\[fluorine-18\] (18F)-fluoromethylcholine (FMC) PET/CT will receive a Gallio-68 (68Ga)- Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET)/Computed Tomography (CT) scan.

Sponsor

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Phase

N/A

Contacts

Federica Matteucci, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02920229

Drug / Compound

PSMA-11

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: HBED-CC

Linker: Ahx

Eligibility

Inclusion

Patients with PSA progression defined as PSA ≥ 1,0 ng/mL and/or PSA rising defined as 2 subsequent values showing PSA increase at least 1 week apart.
Patients must have histologically or cytologically confirmed prostate cancer
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
18F-FMC PET/CT negative or doubtful
Negativity of all the other traditional morphological and functional imaging (transrectal ultrasound, bone scan, CT/MRI)

Exclusion

No radiotherapy in the last 6 months.
No hormonotherapy in the last 6 months
Patients with PSA \< 1.0 ng/ml
Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to Study Agent.