Advanced Prostate CancerPhase 1NCT06062745
Pilot Study for Detection of PSMA-Low CRPC-NE Tumors With Fluciclovine PET/CT
A Phase 1 study testing 18F-fluciclovine and PET/CT in people with Advanced Prostate Cancer and Metastatic Prostate Cancer, run by Brigham and Women's Hospital at 2 sites in United States.
Trial summary
This research study is studying a positron emission tomography (PET) agent called 18F-fluciclovine to evaluate how well 18F-fluciclovine-PET scans determine the extent of advanced prostate cancer that either has low prostate-specific membrane antigen (PSMA) expression or has neuroendocrine features. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Advanced Prostate Cancer, Metastatic Prostate Cancer, Metastatic Prostate Neuroendocrine Carcinoma
- What is being tested?
- 18F-fluciclovine and PET/CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2024to 1 Sep 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 must have histologically confirmed prostate cancer that is metastatic and one of the following: CRPC with PSMA-low disease defined by whole-body SUVmean ≤ 10 determined by standard-of-care 68Ga-PSMA-11 PET/CT imaging with at least 5 metastatic lesions OR NEPC pathology based on tumor biopsy. This may include morphology consistent with small cell carcinoma or mixed adenocarcinoma/NE features and/or IHC staining for NE markers. Participants should have at least 5 metastatic lesions.
- Must have either already had standard of care 68Ga-PSMA PET/CT scan or be planned for 68Ga-PSMA PET/CT scan before or after the planned 18F-fluciclovine-PET/CT.
- Age ≥18 years. Since no dosing or adverse event data are currently available on the use of 18F-fluciclovine in participants <18 years of age, and most prostate cancer occurs in the adult population, children are excluded from this study but will be eligible for future pediatric trials.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- Ability and willingness to comply with the study procedures.
- The effects of 18F-fluciclovine on the developing human fetus are unknown. For this reason and because radiopharmaceuticals may be teratogenic, men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for 24 hours after the PET/CT scan is completed.
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Participants with other known malignancy requiring treatment
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Contraindications for PET/CT including:
- Severe claustrophobia
- Any past or current condition that in the opinion of the study investigators would confound the results of the study or pose additional risk to the patient by their participation in the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Heather Jacene, MD, 617-632-3767, hjacene@partners.org
Heather Jacene, MD
- Recruiting
Brigham and Womens Hospital
Boston, Massachusetts, 02215
Heather A Jacene, MD, 617 632-3767, hjacene@partners.org
Heather A Jacene, MD
About this study
Official title: A Pilot Study for Detection of PSMA-Low Castration Resistant and Neuroendocrine Prostate Cancer With 18F-fluciclovine PET/CT Imaging
This research study is studying a positron emission tomography (PET) agent called 18F-fluciclovine to evaluate how well 18F-fluciclovine-PET scans determine the extent of advanced prostate cancer that either has low prostate-specific membrane antigen (PSMA) expression or has neuroendocrine features.
The name of the study interventions are:
- 18F-fluciclovine-PET/CT scan
- Two research blood collections
Read the detailed description
This research study is a pilot study, which is the first-time investigators are examining this study imaging agent, 18F-fluciclovine, for use in PSMA-low castration resistant and neuroendocrine prostate cancer detection.
18F-fluciclovine is approved by the U.S. Food and Drug Administration (FDA). It is approved for imaging the early stages of prostate cancer. It is not approved for imaging PSMA-low castration resistant or neuroendocrine prostate cancer. 18F-fluciclovine is a radiotracer for PET imaging that targets amino-acid receptors. Some information shows that both PSMA-low and neuroendocrine prostate tumors use amino acids for energy. The purpose of this study to determine if PSMA-low and neuroendocrine prostate cancer can be seen with 18F-fluciclovine-PET/CT. Secondary aims are better understanding of the role of amino acids and PSMA in PSMA low and neuroendocrine prostate cancer and how imaging tests can be used together to optimize treatments for PSMA-low and neuroendocrine prostate cancer.
Participants will receive a PSMA-PET/CT as part standard of care and as part of the study receive 18F-fluciclovine-PET/CT scan along with two research blood collections.
Blue Earth Diagnostics Inc. is supporting this research study by providing the 18Ffluciclovine and funding for the research study.
- Conditions
- Advanced Prostate Cancer, Metastatic Prostate Cancer, Metastatic Prostate Neuroendocrine Carcinoma
- Being tested
- 18F-fluciclovine, PET/CT
- Keywords
- Advanced Prostate Cancer, Metastatic Prostate Cancer, Metastatic Prostate Neuroendocrine Carcinoma, PSMA-Low Castration Resistant Prostate Cancer
- 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-fluciclovineDrug
Also called Axumin
18F-fluciclovine is a radiotracer targeting amino-acid transporters.Radiotracers are compounds or drugs that are attached to small amounts of a radioactive substance to make images of processes that are happening in the body
PET/CTDevice
Positron emission tomography/computed tomography (PET/CT) uses small amounts of radioactive materials called radiotracers, a special camera and a computer to help evaluate organ and tissue functions.
| Study group | Role | What they receive |
|---|---|---|
| 18F-fluciclovine | Experimental | Participants with low prostate-specific membrane antigen (PSMA) expression or neuroendocrine prostate cancer will receive:
* 18F-fluciclovine PET/CT within 6 weeks of standard of care exam and 68Ga-PSMA PET/CT
* 2x Blood test at time of 18F-fluciclovine PET/CT and prior to treatment as determined by participants primary oncologist Receives: Drug: 18F-fluciclovine; Device: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluciclovine and PSMA Uptake in PSMA Positive Tumors
Number of 18F-fluciclovine positive lesions in PSMA-positive tumors on PET
Number of fluciclovine positive tumors that are PSMA-negative
Measured: Up to 6 months
Fluciclovine and PSMA Uptake in PSMA Negative Tumors
Number of 18F-fluciclovine positive lesions in PSMA-negative tumors on PET
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start1 Feb 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Prostate CancerStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Responsible party
- Principal investigator, Heather A. Jacene, MD, Dana-Farber Cancer Institute
- Investigators
- Heather Jacene, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062745
- Sponsor's protocol ID
- 23-267
- Status last verified
- Nov 2025
- First submitted
- 13 Sep 2023
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for Detection of PSMA-Low Castration Resistant and Neuroendocrine Prostate Cancer With 18F-fluciclovine PET/CT Imaging
- ClinicalTrials.gov ID
- NCT06062745
- Acronym / sponsor ID
- 23-267
- Conditions
- Advanced Prostate Cancer, Metastatic Prostate Cancer, Metastatic Prostate Neuroendocrine Carcinoma
- Keywords
- Advanced Prostate Cancer, Metastatic Prostate Cancer, Metastatic Prostate Neuroendocrine Carcinoma, PSMA-Low Castration Resistant Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 2 Oct 2023 (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 study is studying a positron emission tomography (PET) agent called 18F-fluciclovine to evaluate how well 18F-fluciclovine-PET scans determine the extent of advanced prostate cancer that either has low prostate-specific membrane antigen (PSMA) expression or has neuroendocrine features.
The name of the study interventions are:
- 18F-fluciclovine-PET/CT scan
- Two research blood collections
Detailed description
This research study is a pilot study, which is the first-time investigators are examining this study imaging agent, 18F-fluciclovine, for use in PSMA-low castration resistant and neuroendocrine prostate cancer detection.
18F-fluciclovine is approved by the U.S. Food and Drug Administration (FDA). It is approved for imaging the early stages of prostate cancer. It is not approved for imaging PSMA-low castration resistant or neuroendocrine prostate cancer. 18F-fluciclovine is a radiotracer for PET imaging that targets amino-acid receptors. Some information shows that both PSMA-low and neuroendocrine prostate tumors use amino acids for energy. The purpose of this study to determine if PSMA-low and neuroendocrine prostate cancer can be seen with 18F-fluciclovine-PET/CT. Secondary aims are better understanding of the role of amino acids and PSMA in PSMA low and neuroendocrine prostate cancer and how imaging tests can be used together to optimize treatments for PSMA-low and neuroendocrine prostate cancer.
Participants will receive a PSMA-PET/CT as part standard of care and as part of the study receive 18F-fluciclovine-PET/CT scan along with two research blood collections.
Blue Earth Diagnostics Inc. is supporting this research study by providing the 18Ffluciclovine and funding for the research study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-fluciclovine | Experimental | Drug: 18F-fluciclovine, Device: PET/CTParticipants with low prostate-specific membrane antigen (PSMA) expression or neuroendocrine prostate cancer will receive: * 18F-fluciclovine PET/CT within 6 weeks of standard of care exam and 68Ga-PSMA PET/CT * 2x Blood test at time of 18F-fluciclovine PET/CT and prior to treatment as determined by participants primary oncologist |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants must have histologically confirmed prostate cancer that is metastatic and one of the following: CRPC with PSMA-low disease defined by whole-body SUVmean ≤ 10 determined by standard-of-care 68Ga-PSMA-11 PET/CT imaging with at least 5 metastatic lesions OR NEPC pathology based on tumor biopsy. This may include morphology consistent with small cell carcinoma or mixed adenocarcinoma/NE features and/or IHC staining for NE markers. Participants should have at least 5 metastatic lesions.
- Must have either already had standard of care 68Ga-PSMA PET/CT scan or be planned for 68Ga-PSMA PET/CT scan before or after the planned 18F-fluciclovine-PET/CT.
- Age ≥18 years. Since no dosing or adverse event data are currently available on the use of 18F-fluciclovine in participants <18 years of age, and most prostate cancer occurs in the adult population, children are excluded from this study but will be eligible for future pediatric trials.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- Ability and willingness to comply with the study procedures.
Key exclusion criteria (6 listed)
- Participants with other known malignancy requiring treatment
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Contraindications for PET/CT including:
- Any past or current condition that in the opinion of the study investigators would confound the results of the study or pose additional risk to the patient by their 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 |
|---|---|---|
| 18F-fluciclovineAlso: Axumin18F-fluciclovine is a radiotracer targeting amino-acid transporters.Radiotracers are compounds or drugs that are attached to small amounts of a radioactive substance to make images of processes that are happening in the body | Drug | 18F-fluciclovine |
| PET/CTPositron emission tomography/computed tomography (PET/CT) uses small amounts of radioactive materials called radiotracers, a special camera and a computer to help evaluate organ and tissue functions. | Device | 18F-fluciclovine |
Primary outcome
Fluciclovine and PSMA Uptake in PSMA Positive Tumors
Time frame: Up to 6 months
Number of 18F-fluciclovine positive lesions in PSMA-positive tumors on PET Number of fluciclovine positive tumors that are PSMA-negative
Fluciclovine and PSMA Uptake in PSMA Negative Tumors
Time frame: up to 6 months
Number of 18F-fluciclovine positive lesions in PSMA-negative tumors on PET
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Heather Jacene, MD principal investigator
Dana-Farber Cancer Institute
2 sites 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-fluciclovine and PET/CT in people with Advanced Prostate Cancer and Metastatic Prostate Cancer, run by Brigham and Women's Hospital at 2 sites 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Jacene, MD (617-632-3767, hjacene@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluciclovine and PSMA Uptake in PSMA Positive Tumors (time frame: Up to 6 months). 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 29 Oct 2026.