Metastatic Prostate CancerPhase 1NCT04528199
[18F]FLOR (FC303) PET/CT Imaging in Patients With Prostate Cancer
A Phase 1 study testing [18F]FLOR (FC303) Injection in people with Metastatic Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
The study is an open label, single-arm study designed to evaluate the safety and diagnostic performance of [18F]FLOR (FC303) PET/CT imaging to determine the presence or absence of metastatic prostate cancer. . Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- What is being tested?
- [18F]FLOR (FC303) Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 21 Apr 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
- Males ≥18 years of age.
- Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.
- Histologically confirmed adenocarcinoma of the prostate.
- Radiologic evidence of local recurrence or new or progressive metastatic disease demonstrated on anatomical imaging (CT, or MRI), or whole-body bone scan within 4 weeks of Day 1.
- At least 2 weeks must have elapsed between last anti-cancer treatment administration and the imaging day. Imaging day will be scheduled before initiation of new systemic therapy for recurrent and/or progressive metastatic disease
- Screening clinical laboratory values within normal limits or judged not clinically significant by the investigator.
Who cannot join
- Subjects administered any radioisotope within five physical half-lives prior to study drug injection.
- Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study of [18F]FLOR (FC303) PET/CT Imaging in Patients With Prostate Cancer
The study is an open label, single-arm study designed to evaluate the safety and diagnostic performance of [18F]FLOR (FC303) PET/CT imaging to determine the presence or absence of metastatic prostate cancer. .
Read the detailed description
This research is being done to determine whether the radioactive compound called [18F]FLOR (FC303) is safe and well-tolerated in patients with metastatic prostate cancer.
Participants in this study will have tests, exams and procedures that are for study purposes. Participants will be in this study up to one month which will include up to three clinic visits.
Eligible patients diagnosed with metastatic prostate cancer will undergo a [18F]FLOR (FC303) PET-CT scan. This is the imaging procedure to assess where [18F]FLOR (FC303) has accumulated in the body.
- Conditions
- Metastatic Prostate Cancer
- Being tested
- [18F]FLOR (FC303) Injection
- Keywords
- [18F]FLOR, PET/CT, prostate cancer, J19145
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FLOR (FC303) InjectionDrug
Single dose of 10 ±1 millicurie (mCi) of [18F]FLOR (FC303) injection followed by the PET/CT scan.
| Study group | Role | What they receive |
|---|---|---|
| [18F]FLOR (FC303) | Experimental | [18F]FLOR (FC303) PET/CT imaging. Receives: Drug: [18F]FLOR (FC303) Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of study drug emergent adverse events
Incidence of study drug emergent adverse events will be assessed.
Measured: Up to 10 days post-study drug dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start1 Feb 2021
- Primary completion21 Apr 2023
- Study completion21 Apr 2023
Why it stopped: The Principal Investigator decided to terminate the study because the PI left Hopkins.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- FutureChem
- Responsible party
- Sponsor
- Investigators
- Steven Rowe, M.D., Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528199
- Sponsor's protocol ID
- J19145
- Other IDs
- IRB00231620
- Status last verified
- Jan 2024
- First submitted
- 24 Aug 2020
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of [18F]FLOR (FC303) PET/CT Imaging in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT04528199
- Acronym / sponsor ID
- J19145
- Conditions
- Metastatic Prostate Cancer
- Keywords
- [18F]FLOR, PET/CT, prostate cancer, J19145
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Principal Investigator decided to terminate the study because the PI left Hopkins.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- FutureChem
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 21 Apr 2023 (actual)
- Study completion
- 21 Apr 2023 (actual)
- First posted
- 27 Aug 2020 (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.
The study is an open label, single-arm study designed to evaluate the safety and diagnostic performance of [18F]FLOR (FC303) PET/CT imaging to determine the presence or absence of metastatic prostate cancer. .
Detailed description
This research is being done to determine whether the radioactive compound called [18F]FLOR (FC303) is safe and well-tolerated in patients with metastatic prostate cancer.
Participants in this study will have tests, exams and procedures that are for study purposes. Participants will be in this study up to one month which will include up to three clinic visits.
Eligible patients diagnosed with metastatic prostate cancer will undergo a [18F]FLOR (FC303) PET-CT scan. This is the imaging procedure to assess where [18F]FLOR (FC303) has accumulated in the body.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]FLOR (FC303) | Experimental | Drug: [18F]FLOR (FC303) Injection[18F]FLOR (FC303) PET/CT imaging. |
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)
- Males ≥18 years of age.
- Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.
- Histologically confirmed adenocarcinoma of the prostate.
- Radiologic evidence of local recurrence or new or progressive metastatic disease demonstrated on anatomical imaging (CT, or MRI), or whole-body bone scan within 4 weeks of Day 1.
- At least 2 weeks must have elapsed between last anti-cancer treatment administration and the imaging day. Imaging day will be scheduled before initiation of new systemic therapy for recurrent and/or progressive metastatic disease
Key exclusion criteria (2 listed)
- Subjects administered any radioisotope within five physical half-lives prior to study drug injection.
- Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.
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 |
|---|---|---|
| [18F]FLOR (FC303) InjectionSingle dose of 10 ±1 millicurie (mCi) of [18F]FLOR (FC303) injection followed by the PET/CT scan. | Drug | [18F]FLOR (FC303) |
Primary outcome
Incidence of study drug emergent adverse events
Time frame: Up to 10 days post-study drug dosing
Incidence of study drug emergent adverse events will be assessed.
Results and safety
The study was stopped early (reason given: The Principal Investigator decided to terminate the study because the PI left Hopkins.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
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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.
Steven Rowe, M.D., Ph.D. principal investigator
Johns Hopkins University
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 [18F]FLOR (FC303) Injection in people with Metastatic Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 2 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: stopped early, as of the sponsor's last update on 16 Jan 2024. 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 was stopped early (reason given: The Principal Investigator decided to terminate the study because the PI left Hopkins.). Results are not available in the source record.
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?
Incidence of study drug emergent adverse events (time frame: Up to 10 days post-study drug dosing). 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 16 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.