Prostate CancerPhase 2BOPNCT05613842
Copper-64 SAR Bombesin in PSMA Negative Prostate Cancer (BOP)
A Phase 2 study testing Copper-64 labelled SAR-Bombesin in people with Prostate Cancer, run by St Vincent's Hospital, Sydney at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Copper-64 labelled SAR-Bombesin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Aug 2022to 6 Jun 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Diagnostic Value of 64Cu-SAR-BBN PET Imaging for Men With Negative PSMA PET in Prostate Cancer
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).
Read the detailed description
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).
The study will involve men who are being staged or re-staged for metastatic prostate cancer by their treating doctor. The treating doctor will refer the patient to the nuclear medicine department at St. Vincent's Hospital, Sydney for study enrolment.
Screening and D0 visits will be combined for this study. Standard of care bloods (haematology, biochemistry, eGFR and PSA) will be collected at screening/D0 if the results are not already available from the treating doctor. Prior 68Ga-PSMA-11 PET scan within 3 months will be collected from the treating doctor. The PI will ensure that the bloods and 68Ga-PSMA-11 PET scan are reviewed to establish final eligibility before participant undergoes 64Cu-SAR-BBN injection (200mbq) and imaging.
After screening/Day 0 visit, the participant will undergo two imaging scans at 1 hour and 3 hours after having 64Cu-SAR-BBN administration. Total lesional assessment will be calculated with MIM Encore 6.8.7 (MIM Software, Cleveland) using data from the above time points. Safety assessment will be conducted once the participant is enrolled in the study at screening/Day 0 and 48 hours post 3 hours scan by phone call. All adverse events will be recorded on a case report form as source documentation.
- Conditions
- Prostate Cancer
- Being tested
- Copper-64 labelled SAR-Bombesin
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copper-64 labelled SAR-BombesinDrug
Also called 64Cu-SAR-BBN
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.
| Study group | Role | What they receive |
|---|---|---|
| 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); Receives: 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. Receives: Drug: Copper-64 labelled SAR-Bombesin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 %
Measured: 24 months
Secondary outcomes (3)
To assess the diagnostic value of 64Cu-SAR-BBN PET
In the detection of PSMA negative biochemically recurrent or metastatic prostate cancer using a composite standard of truth (biopsy, concurrent imaging and response to targeted therapy)
Measured: 24 months
To evaluate 64Cu-SAR-BBN PET quantitative findings
(SUV max, SUV mean) and sites of metastatic disease and assess the potential for BBN as a therapeutic agent in men with PSMA negative or low PSMA expression disease.
Measured: 24 months
To determine the optimal timing for imaging post BBN injection
with a 1 hour and 3 hours image.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start9 Aug 2022
- Primary completion6 Jun 2023
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Vincent's Hospital, Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- Clarity Pharmaceuticals Ltd
- Responsible party
- Principal investigator, Louise Emmett, St Vincent's Hospital, Sydney
- Investigators
- Louise Emmett, Prof, Principal investigator, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613842
- Sponsor's protocol ID
- 062022-01
- Acronym
- BOP
- Status last verified
- Sep 2023
- First submitted
- 31 Oct 2022
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Diagnostic Value of 64Cu-SAR-BBN PET Imaging for Men With Negative PSMA PET in Prostate Cancer
- ClinicalTrials.gov ID
- NCT05613842
- Acronym / sponsor ID
- BOP / 062022-01
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- St Vincent's Hospital, SydneyUniversity, hospital or other
- Collaborators
- Clarity Pharmaceuticals Ltd
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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).
The study will involve men who are being staged or re-staged for metastatic prostate cancer by their treating doctor. The treating doctor will refer the patient to the nuclear medicine department at St. Vincent's Hospital, Sydney for study enrolment.
Screening and D0 visits will be combined for this study. Standard of care bloods (haematology, biochemistry, eGFR and PSA) will be collected at screening/D0 if the results are not already available from the treating doctor. Prior 68Ga-PSMA-11 PET scan within 3 months will be collected from the treating doctor. The PI will ensure that the bloods and 68Ga-PSMA-11 PET scan are reviewed to establish final eligibility before participant undergoes 64Cu-SAR-BBN injection (200mbq) and imaging.
After screening/Day 0 visit, the participant will undergo two imaging scans at 1 hour and 3 hours after having 64Cu-SAR-BBN administration. Total lesional assessment will be calculated with MIM Encore 6.8.7 (MIM Software, Cleveland) using data from the above time points. Safety assessment will be conducted once the participant is enrolled in the study at screening/Day 0 and 48 hours post 3 hours scan by phone call. All adverse events will be recorded on a case report form as source documentation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Male patients with hormone sensitive disease | Experimental | Drug: Copper-64 labelled SAR-Bombesinwho 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 | Experimental | Drug: Copper-64 labelled SAR-Bombesinbeing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Copper-64 labelled SAR-BombesinAlso: 64Cu-SAR-BBNradiolabeled 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. | Drug | Male patients with hormone sensitive disease, Male patients with metastatic castration resistant prostate cancer |
Primary outcome
Explore the diagnostic potential of 64Cu-SAR-BBN PET In men with rising PSA and negative PSMA PET in the 2 cohorts
Time frame: 24 months
sensitivity,specificity and accuracy for the detection of primary cancer in %
3 secondary outcomes
To assess the diagnostic value of 64Cu-SAR-BBN PET
Time frame: 24 months
To evaluate 64Cu-SAR-BBN PET quantitative findings
Time frame: 24 months
To determine the optimal timing for imaging post BBN injection
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise Emmett, Prof principal investigator
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Copper-64 labelled SAR-Bombesin in people with Prostate Cancer, run by St Vincent's Hospital, Sydney at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explore the diagnostic potential of 64Cu-SAR-BBN PET In men with rising PSA and negative PSMA PET in the 2 cohorts (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.