Clinical Trial · NCT07052214

PSMA PET Combined With MRI for the Detection of PCa

Overview

This is an open label, longitudinal Phase 3 study of prostate specific membrane antigen (PSMA) positron emission tomography (PET) combined with magnetic resonance imaging (MRI) compared to standard of care (SOC) for the detection of prostate cancer (PCa).

Sponsor

Telix Pharmaceuticals

Phase

Phase 3

ClinicalTrials.gov

NCT07052214

Drug / Compound

PSMA-11

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: HBED-CC

Eligibility

Inclusion

Must agree to practice adequate precautions to prevent pregnancy in a female partner and to avoid potential problems associated with radiation exposure to the unborn child (Recommendations related to contraception and pregnancy testing in clinical trials Version 1.1, (CTFG \[Clinical Trial Facilitation Group\], 2020). Details of contraceptive measures to be taken by male participants and their female partners are described in Appendix 4 of the Protocol.
Participants must comply with the radiation protection rules (including hospital admissions and isolation) that are used by the treating institution to protect their contacts and the general public, especially if a female partner of the participant is or could be pregnant.
Provides consent for anatomical template with/without targeted biopsy based on clinical risk, MRI and PSMA PET result.
Prostate biopsy naïve.
Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2 per FDA guidelines.
Have the capacity to understand the study and be able and willing to comply with all protocol requirements.

Exclusion

Participants are excluded from the study if any of the following criteria apply:
Has prior diagnosis of csPCa

Patient Education

Patient education not yet provided.

Publications

Publications not yet provided.

Locations

Loading…