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

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St Vincent's Hospital, Sydney
• Collaborator: Clarity Pharmaceuticals Ltd
• Treatments: Bombesin; Copper

Criteria

Inclusion Criteria:

• Ability to provide informed consent documentation indicating that they understand the purpose and procedures required for the study, and are willing to participate in the study;

• 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);

• 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.

Exclusion Criteria:

• 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;

• ECOG status higher than 2;

• Major surgery (any procedure requiring general anaesthesia) within 6 weeks prior to screening visit;

• History of significant active cancers requiring treatment other than prostate cancer as per Investigator discretion;

• Any other reason that the investigator considers that would make the patient unsuitable to participate in the study.

• eGFR < 40 mL/min/1.73m2