A Phase 2/3,PSMA-T4, Prostate Cancer

Description:

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

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