Prostate CancerPhase 1NCT03073395
Preliminary Evaluation of Uptake of [68Ga]P16-093 in Metastatic Prostate and Renal Cancer
A Phase 1 study testing [68Ga]P16-093 in people with Prostate Cancer and Renal Cancer, run by Five Eleven Pharma, Inc. at 1 site in United States.
Trial summary
An phase I study to evaluate the uptake of [68Ga]P16-093 in known or suspected metastatic prostate or renal cancer to establish the feasibility of using [68Ga]P16-093 to image PSMA expressing cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Renal Cancer
- What is being tested?
- [68Ga]P16-093
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2017to 27 Oct 2023
- Phase
- 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
- Participants will be male ≥ 18 years of age
- History of histologically confirmed cancer that meets criteria for either a) or b)
- Prostate cancer with known or suspected recurrent or metastatic disease based on clinical imaging (e.g. CT, bone scan, MRI, ultrasound, FDG PET/CT, FACBC PET/CT) within 12 months of screening. If subject is post curative-intent local treatment (e.g. radical prostatectomy, local radiotherapy, brachytherapy) they must have had no intervening change in cancer treatment.
- OR
- Renal Cell cancer with known or suspected metastatic disease based on clinical imaging (e.g. CT, bone scan, MRI, ultrasound, FDG PET/CT)
- Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
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- Participants will be male ≥ 18 years of age
- History of prostate cancer that is post curative-intent local treatment (e.g. radical prostatectomy, local radiotherapy, brachytherapy) with clinical PSA levels that meet one of the following criteria
- Post-Prostatectomy (with or without adjuvant RT): PSA level that is < 0.2 ng/mL measured over at least 2 consecutive tests OR
- Post-Radiotherapy: PSA level that has not risen from nadir measured over at least 2 consecutive tests
- If clinical imaging (e.g. bone scan, CT, MRI, ultrasound, PET/CT) has been done within 3 months of screening as part of standard clinical surveillance it must be negative or equivocal for sites of recurrent or metastatic disease (clinical imaging is not required for enrollment)
- Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
Who cannot join
- Estimated creatinine clearance (eGFR) < 30 mL/min (calculated from serum creatinine result within 30 days of screening)
- Chemotherapy or radiation therapy within 2 weeks of screening
- 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 completion of the study
- BIODISTRIBUTION GROUP:
- Estimated creatinine clearance (eGFR) < 30 mL/min (calculated from serum creatinine result within 30 days of screening)
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- Androgen deprivation therapy (ADT) within 3 months prior to screening
- Chemotherapy or radiation therapy within 2 weeks of screening
- 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 completion of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Preliminary Investigation of Uptake in PSMA Expressing Cancer, Biodistribution and Excretion of the Novel Radio Tracer [68Ga]P16-093 by PET/CT
An phase I study to evaluate the uptake of [68Ga]P16-093 in known or suspected metastatic prostate or renal cancer to establish the feasibility of using [68Ga]P16-093 to image PSMA expressing cancer. Measurement of the whole body biodistribution of [68Ga]P16-093 in prostate cancer patients post primary curative-intent treatment with stable PSA to generate human radiation dosimetry data.
- Conditions
- Prostate Cancer, Renal Cancer
- Being tested
- [68Ga]P16-093
- Medical subject headings
- Prostatic Neoplasms, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]P16-093Drug
Imaging by Positron Emission Tomography after iv injection of [68Ga]P16-093
| Study group | Role | What they receive |
|---|---|---|
| Dynamic group | Experimental | Dynamic imaging of suspected metastatic lesions with the investigation drug [68Ga]P16-093 in patients with a history of histologically confirmed cancer. Receives: Drug: [68Ga]P16-093 |
| Biodistribution group | Experimental | Whole body imaging to determine human dosimetry of the investigational drug [68Ga]P16-093 Receives: Drug: [68Ga]P16-093 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of [68Ga]P16-093 in metastatic prostate and renal cancer
Standard uptake value (SUV) of [68Ga]P16-093 in apparent lesions detected by PET/CT.
Measured: 0.5 - 3 hours after injection
Radiation dosimetry of [68Ga]P16-093 in patients with a history of prostate cancer
Radiation dosimetry (organ absorbed dose and effective dose) will be determined using region of interest data drawn on sequential PET/CT images and data from blood and / or urine obtained during scanning.
Measured: up to 3 hours after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start21 Jul 2017
- Primary completion27 Oct 2023
- Study completion27 Oct 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 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT03073395
- Sponsor's protocol ID
- 511-0003-A
- Status last verified
- Feb 2025
- First submitted
- 28 Feb 2017
- Last updated
- 26 Feb 2025
- 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 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Investigation of Uptake in PSMA Expressing Cancer, Biodistribution and Excretion of the Novel Radio Tracer [68Ga]P16-093 by PET/CT
- ClinicalTrials.gov ID
- NCT03073395
- Acronym / sponsor ID
- 511-0003-A
- Conditions
- Prostate Cancer, Renal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Five Eleven Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jul 2017 (actual)
- Primary completion
- 27 Oct 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 8 Mar 2017 (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.
An phase I study to evaluate the uptake of [68Ga]P16-093 in known or suspected metastatic prostate or renal cancer to establish the feasibility of using [68Ga]P16-093 to image PSMA expressing cancer. Measurement of the whole body biodistribution of [68Ga]P16-093 in prostate cancer patients post primary curative-intent treatment with stable PSA to generate human radiation dosimetry data.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic group | Experimental | Drug: [68Ga]P16-093Dynamic imaging of suspected metastatic lesions with the investigation drug [68Ga]P16-093 in patients with a history of histologically confirmed cancer. |
| Biodistribution group | Experimental | Drug: [68Ga]P16-093Whole body imaging to determine human dosimetry of the investigational drug [68Ga]P16-093 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants will be male ≥ 18 years of age
- History of histologically confirmed cancer that meets criteria for either a) or b)
- OR
- Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
- Participants will be male ≥ 18 years of age
Key exclusion criteria (10 listed)
- Estimated creatinine clearance (eGFR) < 30 mL/min (calculated from serum creatinine result within 30 days of screening)
- Chemotherapy or radiation therapy within 2 weeks of screening
- 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 completion of the study
- Estimated creatinine clearance (eGFR) < 30 mL/min (calculated from serum creatinine result within 30 days of screening)
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]P16-093Imaging by Positron Emission Tomography after iv injection of [68Ga]P16-093 | Drug | Biodistribution group, Dynamic group |
Primary outcome
Uptake of [68Ga]P16-093 in metastatic prostate and renal cancer
Time frame: 0.5 - 3 hours after injection
Standard uptake value (SUV) of [68Ga]P16-093 in apparent lesions detected by PET/CT.
Radiation dosimetry of [68Ga]P16-093 in patients with a history of prostate cancer
Time frame: up to 3 hours after injection
Radiation dosimetry (organ absorbed dose and effective dose) will be determined using region of interest data drawn on sequential PET/CT images and data from blood and / or urine obtained during scanning.
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 Feb 2025.
- 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.
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 Phase 1 study testing [68Ga]P16-093 in people with Prostate Cancer and Renal Cancer, 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 12 inclusion and 10 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 Feb 2025. 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?
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.
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?
Uptake of [68Ga]P16-093 in metastatic prostate and renal cancer (time frame: 0.5 - 3 hours after 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 26 Feb 2025.