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Clinical Trial · NCT05847166
A Phase 2/3,PSMA-T4, Prostate Cancer
Overview
The objectives of this study are to evaluate the feasibility and safety of \[99mTc\]Tc-PSMA-T4 in the diagnosis and treatment planning of prostate cancer.
Sponsor
Unknown Organization
Phase
N/A
Contacts
Piotr Garnuszek, Sponsor (CONTACT)
piotr.garnuszek@polatom.pl
+48 22 273 1700
Piotr Garnuszek, Sponsor (STUDY_DIRECTOR)
Katarzyna Socko, CRO (CONTACT)
k.socko@genelytica.com
ClinicalTrials.gov
NCT05847166Eligibility
Inclusion
- Pelvic mpMRI prostate with PIRADS 2.1 score within 12 weeks before screening, only for cohorts A and B.
- No prior treatment for prostate cancer.Cohort C:Biochemical failure after radical prostatectomy defined as failure of PSA to fall to undetectable levels (PSA persistence) or undetectable PSA after radical prostatectomy with a subsequent detectable PSA that increases on 2 or more determinations (PSA recurrence) OR biochemical failure after definitive radiotherapy based on Phoenix Consensus (a rise by 2 ng/mL or more above the nadir PSA) OR radiographic evidence of metastatic disease without PSA persistence/recurrence OR clinical symptoms suggesting distant metastases (Roach et al.., 2006).
Exclusion
Exclusion criteria not yet provided.
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