Prostate CancerEarly Phase 1NCT02826382
Preliminary Evaluation of Uptake in Bone Metastases and Biodistribution of [68Ga]P15-041
A Early Phase 1 study testing [68Ga]P15-041 in people with Prostate Cancer and Bone Metastases, run by Five Eleven Pharma, Inc. at 1 site in United States.
Trial summary
A phase1 study to demonstrate [68Ga]P15-041 binding to bone metastases in prostate cancer and determination of human dosimetry. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Bone Metastases
- What is being tested?
- [68Ga]P15-041
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2016to 31 Dec 2022
- 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
- histologically confirmed prostate cancer. known or suspected bone metastases referred for a clinical [99mTc]MDP scan
Who cannot join
- Estimated creatinine clearance (GFR) < 30 mL/min (calculated), history of hyperparathyroidism, • Inability to tolerate imaging procedures in the opinion of an investigator or treating physician, • Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania
About this study
Official title: A Preliminary Evaluation of Uptake in Bone Metastases, Biodistribution and Excretion of the Novel Radiotracer [68Ga]P15-041 by PET/CT
A phase1 study to demonstrate [68Ga]P15-041 binding to bone metastases in prostate cancer and determination of human dosimetry.
- Conditions
- Prostate Cancer, Bone Metastases
- Being tested
- [68Ga]P15-041
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]P15-041Drug
Imaging by Positron Emission Tomography after injection of [68Ga]P15-041
| Study group | Role | What they receive |
|---|---|---|
| Dynamic imaging group | Experimental | Dynamic imaging of suspected bone metastases with the investigation drug [68Ga]P15-041 Receives: Drug: [68Ga]P15-041 |
| Whole body dosimetry group | Experimental | Determination of human dosimetry of the investigation drug [68Ga]P15-041 Receives: Drug: [68Ga]P15-041 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time course of uptake of [68Ga]P15-041 in bone metastases
kinetics of [68Ga]P15-041 uptake in known or suspected bone metastases in prostate cancer
Measured: 60 minutes post injection
Time course of whole body distribution of [68Ga]P15-041
whole body distribution of [68Ga]P15-041 used for human dosimetry determination
Measured: 3 hours post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start20 Sep 2016
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Five Eleven Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826382
- Sponsor's protocol ID
- 511-0001-A
- Status last verified
- Jan 2023
- First submitted
- 5 Jul 2016
- Last updated
- 12 Jan 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Evaluation of Uptake in Bone Metastases, Biodistribution and Excretion of the Novel Radiotracer [68Ga]P15-041 by PET/CT
- ClinicalTrials.gov ID
- NCT02826382
- Acronym / sponsor ID
- 511-0001-A
- Conditions
- Prostate Cancer, Bone Metastases
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Five Eleven Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Sep 2016 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 11 Jul 2016 (estimated)
- 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.
A phase1 study to demonstrate [68Ga]P15-041 binding to bone metastases in prostate cancer and determination of human dosimetry.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic imaging group | Experimental | Drug: [68Ga]P15-041Dynamic imaging of suspected bone metastases with the investigation drug [68Ga]P15-041 |
| Whole body dosimetry group | Experimental | Drug: [68Ga]P15-041Determination of human dosimetry of the investigation drug [68Ga]P15-041 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- histologically confirmed prostate cancer. known or suspected bone metastases referred for a clinical [99mTc]MDP scan
Key exclusion criteria (1 listed)
- Estimated creatinine clearance (GFR) < 30 mL/min (calculated), history of hyperparathyroidism, • Inability to tolerate imaging procedures in the opinion of an investigator or treating physician, • Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation 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 |
|---|---|---|
| [68Ga]P15-041Imaging by Positron Emission Tomography after injection of [68Ga]P15-041 | Drug | Dynamic imaging group, Whole body dosimetry group |
Primary outcome
Time course of uptake of [68Ga]P15-041 in bone metastases
Time frame: 60 minutes post injection
kinetics of [68Ga]P15-041 uptake in known or suspected bone metastases in prostate cancer
Time course of whole body distribution of [68Ga]P15-041
Time frame: 3 hours post injection
whole body distribution of [68Ga]P15-041 used for human dosimetry determination
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 12 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 [68Ga]P15-041 in people with Prostate Cancer and Bone Metastases, run by Five Eleven Pharma, Inc. 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 1 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: finished, as of the sponsor's last update on 12 Jan 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?
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?
Time course of uptake of [68Ga]P15-041 in bone metastases (time frame: 60 minutes post injection). The study lists 2 primary outcomes in all. 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 12 Jan 2023.