Prostate CancerPhase 1/2NCT05286840
64Cu-SAR-bisPSMA Positron Emission Tomography of Patients With Known or Suspected Prostate Cancer
A Phase 1/2 study testing 64Cu-SAR-bisPSMA in people with Prostate Cancer, run by Luke Nordquist, MD at 1 site in United States.
Trial summary
This research project is testing a new compound which may potentially detect specific cancer lesions in men with prostate cancer. 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?
- 64Cu-SAR-bisPSMA
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2022to 30 Sep 2023
- Phase
- Phase 1/2
- 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
- Signed an informed consent.
- >18 years of age.
- Known diagnosis of prostate adenocarcinoma confirmed by histopathology OR patients with suspicion of prostate cancer based on elevated PSA but negative standard of care imaging and/or negative biopsy.
- The Eastern Cooperative Oncology (ECOG) performance status 0-2.
- Adequate recovery from acute toxic effects of any prior therapy.
- Adequate renal function (eGFR of 30 ml/min/1.73m2 or higher)
Who cannot join
- Participants must not receive other investigational agents within 28 days prior to 64Cu-SAR-bisPSMA administration.
- Patients administered any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to 64Cu-SAR-bisPSMA administration.
- 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
1 site in 1 country.
United States1 site
GU Research Network
Omaha, Nebraska, 68130
Tony Romero, 402-690-3716, tromerojr@gmail.com
Luke Nordquist, MD
About this study
Official title: 64Cu-SAR-bisPSMA Positron Emission Tomography of Patients With Known or Suspected Prostate Cancer: A Prospective, Non-randomized, Single Arm, Single Center, Open-label Phase 1/2 Study
This research project is testing a new compound which may potentially detect specific cancer lesions in men with prostate cancer.
Read the detailed description
This is a prospective, non-randomized, single arm, single center, open-label study of 64Cu-SAR-bisPSMA PET in patients with known or suspected prostate cancer (PC).
Patients will be screened during a 28-day period and assessed against the inclusion and exclusion criteria. During screening the investigator will determine the patient's disease status (for patients with suspected prostate cancer) or stage of disease (for patients with known prostate cancer) and management plan based on the available standard of care test results (including available imaging, histopathology, biochemical markers, clinical and symptoms history, etc.). Eligible patients will receive a single administration of 64Cu-SAR-bisPSMA and complete a PET scan at an early time (1-4 hours) and a late time (24-72 hours).
The patient's status will only be assessed in patients with suspected disease at study entry and will be characterized as suspected or known prostate cancer during the follow up.
Staging will only be assessed in patients with known prostate cancer at study entry and will be characterized according to the TNM system and as Localized, Regional or Distant (nodes/visceral/bone).
- Conditions
- Prostate Cancer
- Being tested
- 64Cu-SAR-bisPSMA
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
64Cu-SAR-bisPSMADiagnostic test
Diagnostic PET/CT imaging agent targeted for Prostate Specific Membrane Antigen (PSMA)
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess safety of 64Cu-SAR-bisPSMA (all patients).
To assess treatment emergent adverse events.
Measured: From injection of 64Cu-SAR-bisPSMA to one week following.
Secondary outcomes (3)
Disease status adjustment (patients with suspected disease at entry) before vs after 64Cu-SAR-bisPSMA PET/CT Imaging.
Disease status will be assessed before and after 64Cu-SAR-bisPSMA PET/CT Imaging.
Measured: Within one week of 64Cu-SAR-bisPSMA PET/CT Imaging
Disease Staging adjustment (for patients with known disease at entry) before vs after 64Cu-SAR-bisPSMA PET/CT Imaging.
Disease staging will be assessed before and after 64Cu-SAR-bisPSMA PET/CT Imaging
Measured: Within one week of 64Cu-SAR-bisPSMA PET/CT Imaging
Clinical Management plan before vs after 64Cu-SAR-bisPSMA PET/CT Imaging.
Clinical Management plan will be documented before and after 64Cu-SAR-bisPSMA PET/CT Imaging.
Measured: Within one week of 64Cu-SAR-bisPSMA PET/CT Imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start28 Mar 2022 (estimated)
- Primary completion28 Mar 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- A prospective, non-randomized, single arm, single center, open-label study .
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luke Nordquist, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Clarity Pharmaceuticals Ltd
- Responsible party
- Sponsor-investigator, Luke Nordquist, MD, GU Research Network, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286840
- Sponsor's protocol ID
- GU22-002
- Status last verified
- Mar 2022
- First submitted
- 28 Feb 2022
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 64Cu-SAR-bisPSMA Positron Emission Tomography of Patients With Known or Suspected Prostate Cancer: A Prospective, Non-randomized, Single Arm, Single Center, Open-label Phase 1/2 Study
- ClinicalTrials.gov ID
- NCT05286840
- Acronym / sponsor ID
- GU22-002
- Conditions
- Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Luke Nordquist, MDUniversity, hospital or other
- Collaborators
- Clarity Pharmaceuticals Ltd
- Study start
- 28 Mar 2022 (estimated)
- Primary completion
- 28 Mar 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 18 Mar 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 research project is testing a new compound which may potentially detect specific cancer lesions in men with prostate cancer.
Detailed description
This is a prospective, non-randomized, single arm, single center, open-label study of 64Cu-SAR-bisPSMA PET in patients with known or suspected prostate cancer (PC).
Patients will be screened during a 28-day period and assessed against the inclusion and exclusion criteria. During screening the investigator will determine the patient's disease status (for patients with suspected prostate cancer) or stage of disease (for patients with known prostate cancer) and management plan based on the available standard of care test results (including available imaging, histopathology, biochemical markers, clinical and symptoms history, etc.). Eligible patients will receive a single administration of 64Cu-SAR-bisPSMA and complete a PET scan at an early time (1-4 hours) and a late time (24-72 hours).
The patient's status will only be assessed in patients with suspected disease at study entry and will be characterized as suspected or known prostate cancer during the follow up.
Staging will only be assessed in patients with known prostate cancer at study entry and will be characterized according to the TNM system and as Localized, Regional or Distant (nodes/visceral/bone).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- A prospective, non-randomized, single arm, single center, open-label study .
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed an informed consent.
- >18 years of age.
- Known diagnosis of prostate adenocarcinoma confirmed by histopathology OR patients with suspicion of prostate cancer based on elevated PSA but negative standard of care imaging and/or negative biopsy.
- The Eastern Cooperative Oncology (ECOG) performance status 0-2.
- Adequate recovery from acute toxic effects of any prior therapy.
Key exclusion criteria (4 listed)
- Participants must not receive other investigational agents within 28 days prior to 64Cu-SAR-bisPSMA administration.
- Patients administered any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to 64Cu-SAR-bisPSMA administration.
- 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-bisPSMADiagnostic PET/CT imaging agent targeted for Prostate Specific Membrane Antigen (PSMA) | Diagnostic test | – |
Primary outcome
To assess safety of 64Cu-SAR-bisPSMA (all patients).
Time frame: From injection of 64Cu-SAR-bisPSMA to one week following.
To assess treatment emergent adverse events.
3 secondary outcomes
Disease status adjustment (patients with suspected disease at entry) before vs after 64Cu-SAR-bisPSMA PET/CT Imaging.
Time frame: Within one week of 64Cu-SAR-bisPSMA PET/CT Imaging
Disease Staging adjustment (for patients with known disease at entry) before vs after 64Cu-SAR-bisPSMA PET/CT Imaging.
Time frame: Within one week of 64Cu-SAR-bisPSMA PET/CT Imaging
Clinical Management plan before vs after 64Cu-SAR-bisPSMA PET/CT Imaging.
Time frame: Within one week of 64Cu-SAR-bisPSMA PET/CT Imaging
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- 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.
1 site 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 Prostate Cancer, run by Luke Nordquist, MD at 1 site 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Mar 2022. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tony Romero (402-697-2229, tromero@gucancer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess safety of 64Cu-SAR-bisPSMA (all patients). (time frame: From injection of 64Cu-SAR-bisPSMA to one week following.). 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 18 Mar 2022.