TheranosticTrials.org

Clinical Trial · NCT04742361

Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer

Overview

This study evaluates the diagnostic performance and safety of \[18F\]PSMA-1007 PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.

Sponsor

Advanced Biochemical Compounds

Phase

Phase 3

ClinicalTrials.gov

NCT04742361

Drug / Compound

PSMA-1007

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

Eligibility

Inclusion

  • after radiotherapy or cryotherapy: 3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir (ASTRO-Phoenix)
  • Willing and able to undergo all study procedures
  • Suspicion of recurrence or persistence
  • Male with original diagnosis of adenocarcinoma of the prostate with prior definitive therapy
  • For patients who previously had radical prostatectomy, salvage radiotherapy is one likely treatment plan; for patients who initially underwent radiotherapy (including brachytherapy), confirmation of low volume disease is needed to define (local) treatment.
  • after prostatectomy, PSA \> 0.2 ng/mL on 2 or more determinations (recurrence), or failure of PSA to fall to undetectable levels post-prostatectomy (persistence) (American Urological Association)
  • Life expectancy of 6 months or more as judged by the investigator

Exclusion

  • Patients who are unable to undergo a PET/CT scan
  • Contraindications to any of the ingredients of \[18F\]PSMA-1007
  • Patients who are unwilling to consider a biopsy if clinically recommended
  • Close affiliation with the investigational site
  • At the time of enrolment into this study, participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial
  • Being clinically unstable or requiring emergency treatment
  • Having been previously enrolled in this clinical trial
  • Patients for whom systemic therapy is the most likely course regardless of PET findings.
  • Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial