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

NCT05613842 | Completed Phase 2

• 1 other identifier: 062022-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Explore the diagnostic potential of 64Cu-SAR-BBN PET In men with rising PSA and negative PSMA PET in the 2 cohorts

  sensitivity,specificity and accuracy for the detection of primary cancer in %

  24 months

Secondary Outcomes (3)

• To assess the diagnostic value of 64Cu-SAR-BBN PET

  24 months

• To evaluate 64Cu-SAR-BBN PET quantitative findings

  24 months

• To determine the optimal timing for imaging post BBN injection

  24 months

Study Arms (2)

Male patients with hormone sensitive disease

EXPERIMENTAL

who demonstrate rising PSA levels (\>0.2ng/ml) following definitive therapy and a negative 68Ga-PSMA-11 PET scan (defined as SUV max \< 3);

Drug: Copper-64 labelled SAR-Bombesin

Male patients with metastatic castration resistant prostate cancer

EXPERIMENTAL

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.

Drug: Copper-64 labelled SAR-Bombesin

Interventions

Copper-64 labelled SAR-Bombesin DRUG

radiolabeled antagonist analog of bombesin for the diagnosis and treatment of gastrin releasing peptide receptor (GRPR)-positive tumors in adults. The product is Copper-64 labelled SAR-Bombesin (Cu-SAR-BBN). Cu-SAR-BBN uses radioactive forms (radionuclide) of copper, copper-64 (64Cu) to image cancers using Positron Emission Tomography (PET) and then copper-67 (67Cu) for therapy by internal beta radiation. 64Cu-SAR-BBN has 3 basic components; the radionuclide (64Cu), bound via MeCOSar (a bifunctional metal chelator, SAR) to a bombesin analog that targets GRPR.

Also known as: 64Cu-SAR-BBN

Male patients with hormone sensitive disease; Male patients with metastatic castration resistant prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St Vincent's Hospital, Sydney: lead
• Clarity Pharmaceuticals Ltd: collaborator

Study Sites (1)

St Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Louise Emmett, Prof

  Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 14, 2022
• Study Start: August 9, 2022
• Primary Completion: June 6, 2023
• Study Completion: June 6, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)