Biochemical Recurrence of Malignant Neoplasm of ProstatePhase 1/2COBRANCT05249127

64Cu-SAR-bisPSMA for Identification of Participants With Recurrence of Prostate Cancer (COBRA)

A Phase 1/2 study testing 64Cu-SAR-bisPSMA in people with Biochemical Recurrence of Malignant Neoplasm of Prostate, run by Clarity Pharmaceuticals Ltd at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The aim of this study is to determine the safety and efficacy of 64Cu-SAR-bisPSMA and determine the ability of 64Cu-SAR-bisPSMA Positron emission tomography (PET)/computed tomography (CT) to correctly detect the recurrence of prostate cancer in participants with biochemical recurrence of prostate cancer following… Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Biochemical Recurrence of Malignant Neoplasm of Prostate
What is being tested?: 64Cu-SAR-bisPSMA
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 5 sitesUnited States
Study dates: 11 Apr 2022to 8 Aug 2023
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

At least 18 years of age.
Signed informed consent.
Life expectancy ≥ 12 weeks as determined by the Investigator.
Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy.
Suspected recurrence of prostate cancer (PC) based on rising Prostate-specific antigen (PSA) after definitive therapy on the basis of:
Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (per American Urological Association recommendation) or

Show all 13Show fewer

Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (per American Society for Therapeutic Radiology and Oncology-Phoenix consensus definition).
Negative or equivocal findings for PC on conventional imaging performed as part of standard of care workup within 60 days prior to Day 0.
The Eastern Cooperative Oncology performance status 0-2.
Adequate recovery from acute toxic effects of any prior therapy.
Estimated Glomerular Filtration Rate of 30 mL/min or higher.
Adequate liver function.
For participants who have partners of childbearing potential: Partner and/or participant must use a method of birth control with adequate barrier protection.

Who cannot join

Participants who received other investigational agents within 28 days prior to Day 0.
Participants administered any high energy (>300 kiloelectronvolts (keV)) gamma-emitting radioisotope within 5 physical half-lives prior to Day 0.
Ongoing treatment or treatment within 90 days of Day 0 with any systemic therapy (e.g. androgen-deprivation therapy, antiandrogen, gonadotropin-releasing hormone, luteinizing hormone-releasing hormone agonist or antagonist) for PC.
Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

New Mexico Cancer Center
Albuquerque, New Mexico, 87109
Tower Urology
Los Angeles, California, 90048
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
GU Research Network
Omaha, Nebraska, 68130
Urology San Antonio
San Antonio, Texas, 78258

Other trials in United States

About this study

Official title: 64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 1/2 Study of Participants With Biochemical Recurrence of Prostate Cancer

Read the detailed description

Participants with biochemical evidence of recurrence of PC were evaluated with 64CU-SAR-bisPSMA PET/CT (Day 0 and Day 1) and by conventional methodologies up to 180 days later, eg. Histopathology/biopsy, conventional imaging, PSA reduction post focal salvage therapy or radiotherapy with no concomitant androgen deprivation therapy. Three independent central readers blinded to the participant number, the time of the PET/CT scan and the results of the conventional methodologies assessed the 64Cu-SAR-bisPSMA PET/CT. Three separate independent readers assessed the results of the conventional methodologies.

Conditions: Biochemical Recurrence of Malignant Neoplasm of Prostate
Being tested: 64Cu-SAR-bisPSMA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

64Cu-SAR-bisPSMADrug
64Cu-SAR-bisPSMA

Study groups in NCT05249127
Study group	Role	What they receive
64Cu-SAR-bisPSMA	Experimental	Patients will receive a single administration of 200 megabecquerels (MBq) of 64Cu-SAR-bisPSMA. Receives: Drug: 64Cu-SAR-bisPSMA

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability
Incidence and severity of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events. Adverse Events were assessed by CTCAE version 5.0
Measured: up to 7 days post injection
Participant-level Correct Detection Rate (CDR)- Day 0
The percentage of TP participants on the Day 0 scan out of all participants with a Day 0 scan.
Measured: Day 0 (1- 4 hours) post injection
Participant-level CDR- Day 1
The percentage of TP participants on the Day 1 scan out of all participants with a Day 1 scan.
Measured: Day 1 (24+/-6 Hours) post injection
Region-level Positive Predictive Value (PPV)- Day 0
The percentage of TP regions on the Day 0 scan out of all positive regions on the Day 0 scan.
Measured: Day 0 (1- 4 hours)
Region-level PPV- Day 1
The percentage of TP regions on the Day 1 scan out of all positive regions on the Day 1 scan.
Measured: Day 1 (24 +/- 6 hours)

Secondary outcomes (10)

Biodistribution of 64Cu-SAR-bisPSMA- SUVmean
The mean Standardized Uptake Value (SUVmean) in lesions, visceral soft tissue and bone.
Measured: Day 0 (1 -4 hours) and Day 1 (24 +/- 6 hours) post injection
Biodistribution of 64Cu-SAR-bisPSMA- SUVmax
SUVmax in lesions, visceral soft tissue and bone
Measured: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)
Biodistribution of 64Cu-SAR-bisPSMA- SUVr
Lesion to Background ratio. SUVmax of the lesion divided by the SUVmean of gluteus background
Measured: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)
Participant-level PPV
Percentage of TP participants on the Day 0 or Day 1 scan out of all participants with a positive Day 0 or Day 1 scan.
Measured: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)
Participant-level Detection Rate (DR)
Percentage of participants with a positive Day 0 or Day 1 scan out of all participants with a Day 0 or Day 1 scan.
Measured: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)
Participant-level False Positive Rate (FPR)
Percentage of false positive (FP) participants on the Day 0 or Day 1 scan out of all participants with a positive Day 0 or Day 1 scan.
Measured: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)
Region-level FPR
Percentage of FP regions on the Day 0 or Day 1 scan out of all positive regions on the Day 0 or Day 1 scan.
Measured: Day 0 (1-4 hours) and Day 1 (24 +/-6 hours)
Participant-level Discrepant PET Negativity Rate
Percentage of participants with contradicting Day 0 and Day 1 results for whom the Reference Standard was positive.
Measured: Day 0 (1-4 hours) and Day 1 (24 +/-6 hours)
Participant-level True Negative Rate (TNR)
Percentage of TN participants on the Day 0 or Day 1 scan out of all participants with a negative Day 0 or Day 1 scan.
Measured: Day 0 (1-4 hours) and Day 1 (24 +/-6 hours)
Region-level TNR
Percentage of TN regions on the Day 0 or Day 1 scan out of all negative regions on the Day 0 or Day 1 scan.
Measured: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Apr 20228 Aug 2023

First posted21 Feb 2022
Study start11 Apr 2022
Primary completion8 Aug 2023
Study completion8 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Biochemical Recurrence of Malignant Neoplasm of ProstateStudies 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 1/2
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05249127
Sponsor's protocol ID: CLP06
Acronym: COBRA
Status last verified: Aug 2024
First submitted: 2 Feb 2022
Last updated: 1 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis
Prostate
RecruitingPhase 2
Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro)
Recurrent Prostate Cancer
RecruitingObservational study
Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL
Prostate Cancer, Biochemically Recurrent
RecruitingPhase 2
IL-15 Superagonist With or Without Vaccine in Biochemically Recurrent Prostate Cancer After Previous Stereotactic Body Radiation Therapy
Recurrent Prostate Cancer, Prostate Cancer
RecruitingPhase 2/3
Dose Optimization and Diagnostic Performance in Prostate Cancer (SPARROW [Staging Prostate Cancer With Advanced RM2 Radiotracer Oncologic Workup])
Prostate Cancer

All Biochemical Recurrence of Malignant Neoplasm of Prostate trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 1/2 Study of Participants With Biochemical Recurrence of Prostate Cancer
ClinicalTrials.gov ID: NCT05249127
Acronym / sponsor ID: COBRA / CLP06
Conditions: Biochemical Recurrence of Malignant Neoplasm of Prostate
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Clarity Pharmaceuticals LtdIndustry (pharma, biotech, devices)
Study start: 11 Apr 2022 (actual)
Primary completion: 8 Aug 2023 (actual)
Study completion: 8 Aug 2023 (actual)
First posted: 21 Feb 2022 (actual)
Results: Posted 1 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
64Cu-SAR-bisPSMA	Experimental	Drug: 64Cu-SAR-bisPSMAPatients will receive a single administration of 200 megabecquerels (MBq) of 64Cu-SAR-bisPSMA.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

At least 18 years of age.
Signed informed consent.
Life expectancy ≥ 12 weeks as determined by the Investigator.
Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy.
Suspected recurrence of prostate cancer (PC) based on rising Prostate-specific antigen (PSA) after definitive therapy on the basis of:

Key exclusion criteria (5 listed)

Participants who received other investigational agents within 28 days prior to Day 0.
Participants administered any high energy (>300 kiloelectronvolts (keV)) gamma-emitting radioisotope within 5 physical half-lives prior to Day 0.
Ongoing treatment or treatment within 90 days of Day 0 with any systemic therapy (e.g. androgen-deprivation therapy, antiandrogen, gonadotropin-releasing hormone, luteinizing hormone-releasing hormone agonist or antagonist) for PC.
Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of 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
64Cu-SAR-bisPSMA64Cu-SAR-bisPSMA	Drug	64Cu-SAR-bisPSMA

Primary outcome

Safety and Tolerability
Time frame: up to 7 days post injection
Incidence and severity of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events. Adverse Events were assessed by CTCAE version 5.0
Participant-level Correct Detection Rate (CDR)- Day 0
Time frame: Day 0 (1- 4 hours) post injection
The percentage of TP participants on the Day 0 scan out of all participants with a Day 0 scan.
Participant-level CDR- Day 1
Time frame: Day 1 (24+/-6 Hours) post injection
The percentage of TP participants on the Day 1 scan out of all participants with a Day 1 scan.
Region-level Positive Predictive Value (PPV)- Day 0
Time frame: Day 0 (1- 4 hours)
The percentage of TP regions on the Day 0 scan out of all positive regions on the Day 0 scan.
Region-level PPV- Day 1
Time frame: Day 1 (24 +/- 6 hours)
The percentage of TP regions on the Day 1 scan out of all positive regions on the Day 1 scan.

10 secondary outcomes

Biodistribution of 64Cu-SAR-bisPSMA- SUVmean
Time frame: Day 0 (1 -4 hours) and Day 1 (24 +/- 6 hours) post injection
Biodistribution of 64Cu-SAR-bisPSMA- SUVmax
Time frame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)
Biodistribution of 64Cu-SAR-bisPSMA- SUVr
Time frame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)
Participant-level PPV
Time frame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)
Participant-level Detection Rate (DR)
Time frame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)
Participant-level False Positive Rate (FPR)
Time frame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)
Region-level FPR
Time frame: Day 0 (1-4 hours) and Day 1 (24 +/-6 hours)
Participant-level Discrepant PET Negativity Rate
Time frame: Day 0 (1-4 hours) and Day 1 (24 +/-6 hours)
Participant-level True Negative Rate (TNR)
Time frame: Day 0 (1-4 hours) and Day 1 (24 +/-6 hours)
Region-level TNR
Time frame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)

Results and safety

Results posted to the registry on 1 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
64Cu-SAR-bisPSMA Injection	52	32

Primary outcome: Safety and Tolerability

Time frame: up to 7 days post injection. Count of participants. Unit: Participants

Measure	64Cu-SAR-bisPSMA Injection n = 52
Any TEAE	10
TEAE Grade 1 to 2	8
TEAE Grade 3	2
TEAE Grade 4 to 5	0
TEAE Related to 64Cu-SAR-bisPSMA	1
Serious TEAE	1
Serious TEAE related to Cu64-SAR-bisPSMA	0
TEAE leading to withdrawal from study	0

Population analysed: All Participants who received any amount of 64Cu-SAR-bisPSMA.

Primary outcome: Participant-level Correct Detection Rate (CDR)- Day 0

Time frame: Day 0 (1- 4 hours) post injection. Number (95% Confidence Interval). Unit: percentage of TP participants

Measure	64Cu-SAR-bisPSMA n = 42
Reader 1	26.2 (13.9 to 42.0)
Reader 2	23.8 (12.1 to 39.5)
Reader 3	19.0 (8.6 to 34.1)

Population analysed: All participants who received any amount of 64Cu-SAR-bisPSMA with 64Cu-SAR-bisPSMA PET/CT imaging results available from at least one central reader and had at least one evaluable reference datapoint (participant-level or region-level).

Primary outcome: Participant-level CDR- Day 1

Time frame: Day 1 (24+/-6 Hours) post injection. Number (95% Confidence Interval). Unit: percentage of TP participants

Measure	64Cu-SAR-bisPSMA PET Injection n = 42
Reader 1	33.3 (19.6 to 49.5)
Reader 2	33.3 (19.6 to 49.5)
Reader 3	26.2 (13.9 to 42.0)

Primary outcome: Region-level Positive Predictive Value (PPV)- Day 0

Time frame: Day 0 (1- 4 hours). Number (95% Confidence Interval). Unit: percentage of TP regions

Measure	64Cu-SAR-bisPSMA Injection n = 42
Reader 1	41.2 (24.6 to 59.3)
Reader 2	44.8 (26.4 to 64.3)
Reader 3	39.1 (19.7 to 61.5)

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 7 days post injection. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Safety Analysis Set	1 of 52 (1.9%)	0 of 52 (0%)	0 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Biochemical Recurrence of Malignant Neoplasm of Prostate

Active, not recruitingPhase 2
Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis
Prostate
RecruitingPhase 2
Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro)
Recurrent Prostate Cancer
RecruitingObservational study
Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL
Prostate Cancer, Biochemically Recurrent
RecruitingPhase 2
IL-15 Superagonist With or Without Vaccine in Biochemically Recurrent Prostate Cancer After Previous Stereotactic Body Radiation Therapy
Recurrent Prostate Cancer, Prostate Cancer
RecruitingPhase 2/3
Dose Optimization and Diagnostic Performance in Prostate Cancer (SPARROW [Staging Prostate Cancer With Advanced RM2 Radiotracer Oncologic Workup])
Prostate Cancer

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.

Othon Gervasio study director

Clarity Pharmaceuticals Ltd

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 64Cu-SAR-bisPSMA in people with Biochemical Recurrence of Malignant Neoplasm of Prostate, run by Clarity Pharmaceuticals Ltd at 5 sites in United States.

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 13 inclusion and 5 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 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Yes. Results are posted in the registry (first posted 1 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Safety and Tolerability (time frame: up to 7 days post injection). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05249127.

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 1 Oct 2024.