TheranosticTrials.org

Clinical Trial · NCT05613842

Copper-64 SAR Bombesin in PSMA Negative Prostate Cancer (BOP)

Overview

This phase 2a study will involve enrolment of men presenting with progression of biopsy proven prostate cancer who require imaging for staging/re-staging of their disease. The participants enrolled will be further sub-stratified into two groups; one group of men with hormone-sensitive disease (cohort A), and a second group of men with castrate-resistant disease being considered for 177Lu-PSMA-617 therapy (Cohort B).

Sponsor

St Vincent's Hospital, Sydney

Phase

Phase 2

Contacts

Louise Emmett, Prof (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05613842

Drug / Compound

SAR-BBN

Isotope(s):
Target(s):
  • GRPR
Ligand Class: Peptides
Chelator: MeCOSar
Linker: PEG4

Eligibility

Inclusion

  • Male patients with metastatic castration resistant prostate cancer being considered for 177Lu-PSMA-617 therapy, with known metastatic disease on conventional imaging and sites with low PSMA expression on 68Ga-PSMA-11 PET scan (defined as SUV max \<10) in the presence of disease volume of \> 1cm.
  • Male patients 18 years or above with hormone sensitive disease, who demonstrate rising PSA levels (\>0.2ng/ml) following definitive therapy and a negative 68Ga-PSMA-11 PET scan (defined as SUV max \< 3);

Exclusion

  • Significant inter-current acute illness including (but not limited to) requiring the use of intravenous antibiotics, illness associated with any signs of haemodynamic instability, or illness as determined by trial investigators that warrant other emergent treatment;
  • Major surgery (any procedure requiring general anaesthesia) within 6 weeks prior to screening visit;
  • Any other reason that the investigator considers that would make the patient unsuitable to participate in the study.
  • eGFR \< 40 mL/min/1.73m2
  • ECOG status higher than 2;
  • History of significant active cancers requiring treatment other than prostate cancer as per Investigator discretion;