Metastatic Castration-resistant Prostate CancerEarly Phase 1NCT05558956
Total Body PET-CT Imaging of Prostate Cancer Using Illuccix
A Early Phase 1 study testing illuccix 68Ga-PSMA-11 Total Body PET-CT in people with Metastatic Castration-resistant Prostate Cancer, run by BAMF Health at 1 site in United States.
Trial summary
Illuccix will be used per the prescribing instructions for PET-CT imaging on the United Imaging scanner uEXPLORER to establish a standard scanning protocol. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- illuccix 68Ga-PSMA-11 Total Body PET-CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to Dec 2023
- Phase
- Early Phase 1
- 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
- Provision of signed and dated informed consent form
- Male ≥ 18 years of age
- Patients meeting clinical need for Illuccix PET scan:
- Patients with suspected metastasis who are candidates for initial definitive therapy
- Patients with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
- Patient is physically able to lay flat for the PET-CT procedure
Who cannot join
- 1. Assessment by the Investigator as unable or unwilling to comply with the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
BAMF Health
Grand Rapids, Michigan, 49503
Dan Rogers, 616-330-3886, clinical.research@bamfhealth.com
About this study
Official title: Total Body PET-CT Imaging of Prostate Cancer Using Illuccix (Kit for the Preparation of Ga-68 PSMA-11 Injection)
Illuccix will be used per the prescribing instructions for PET-CT imaging on the United Imaging scanner uEXPLORER to establish a standard scanning protocol.
- Being tested
- illuccix 68Ga-PSMA-11 Total Body PET-CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
illuccix 68Ga-PSMA-11 Total Body PET-CTDrug
Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) 68Ga-PSMA-11
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | 3 mCi dose of 68Ga-PSMA-11 (Illuccix) and a total body PET-CT scan for 4-6 min scan time. Receives: Drug: illuccix 68Ga-PSMA-11 Total Body PET-CT |
| High dose | Experimental | 7 mCi dose of 68Ga-PSMA-11 (Illuccix) and a total body PET-CT scan for 4-6 min scan time. Receives: Drug: illuccix 68Ga-PSMA-11 Total Body PET-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the imaging quality using low dose and high dose Ga-68 PSMA-11 at various scan lengths.
In modulating the dose and scan time, including reconstitution of the images, we will identify optimal protocol for use of Illuccix on total body PET/CT through evaluation of image quality at variable dose and scan length.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start1 Nov 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BAMF Health
- Sponsor type
- University, hospital or other
- Collaborators
- Telix Pharmaceuticals (Innovations) Pty Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558956
- Sponsor's protocol ID
- BAMF-2022-03
- Status last verified
- Mar 2023
- First submitted
- 23 Sep 2022
- Last updated
- 27 Jul 2023
- 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Body PET-CT Imaging of Prostate Cancer Using Illuccix (Kit for the Preparation of Ga-68 PSMA-11 Injection)
- ClinicalTrials.gov ID
- NCT05558956
- Acronym / sponsor ID
- BAMF-2022-03
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- BAMF HealthUniversity, hospital or other
- Collaborators
- Telix Pharmaceuticals (Innovations) Pty Limited
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 28 Sep 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.
Illuccix will be used per the prescribing instructions for PET-CT imaging on the United Imaging scanner uEXPLORER to establish a standard scanning protocol.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Drug: illuccix 68Ga-PSMA-11 Total Body PET-CT3 mCi dose of 68Ga-PSMA-11 (Illuccix) and a total body PET-CT scan for 4-6 min scan time. |
| High dose | Experimental | Drug: illuccix 68Ga-PSMA-11 Total Body PET-CT7 mCi dose of 68Ga-PSMA-11 (Illuccix) and a total body PET-CT scan for 4-6 min scan time. |
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)
- Provision of signed and dated informed consent form
- Male ≥ 18 years of age
- Patients meeting clinical need for Illuccix PET scan:
- Patient is physically able to lay flat for the PET-CT procedure
Key exclusion criteria (1 listed)
- 1. Assessment by the Investigator as unable or unwilling to comply with the requirements of the protocol.
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 |
|---|---|---|
| illuccix 68Ga-PSMA-11 Total Body PET-CTIlluccix (kit for the preparation of gallium Ga 68 gozetotide injection) 68Ga-PSMA-11 | Drug | High dose, Low Dose |
Primary outcome
Comparing the imaging quality using low dose and high dose Ga-68 PSMA-11 at various scan lengths.
Time frame: 3 months
In modulating the dose and scan time, including reconstitution of the images, we will identify optimal protocol for use of Illuccix on total body PET/CT through evaluation of image quality at variable dose and scan length.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Metastatic Castration-resistant Prostate Cancer
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STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
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A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
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ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing illuccix 68Ga-PSMA-11 Total Body PET-CT in people with Metastatic Castration-resistant Prostate Cancer, run by BAMF Health 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 1 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 27 Jul 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 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Dan Rogers (616-330-3886, clinical.research@bamfhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the imaging quality using low dose and high dose Ga-68 PSMA-11 at various scan lengths. (time frame: 3 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 27 Jul 2023.