Prostate Cancer (Adenocarcinoma)NCT06862856
Flotufolastat F 18 PET in Men With Very Low PSA Recurrence
An observational study of Prostate Cancer (Adenocarcinoma) and Prostate Specific Antigen, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The purpose of this study is to assess detection rate of flotufolastat F 18 positron emission tomography (PET) for low prostate specific antigen (PSA) recurrence of prostate cancer (PC) following radical prostatectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma), Prostate Specific Antigen
- What is being tested?
- Positron Emission Tomography (PET)
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 May 2025to 1 Dec 2026
- Phase
- Observational
- 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
Study population: Participants will be identified and screened for eligibility via physician referral, clinic visit, or medical record review.
Who may be able to join
- Participants must have a history of localized histologically confirmed adenocarcinoma of the prostate and have received radical prostatectomy (RP) with curative intent.
- Participants must have measurable disease, defined as a non-zero PSA value post-RP that is concerning for biochemically recurrent or persistent disease, is ≤0.20 ng/mL, and obtained within 60 days of PET/CT.
- At least 6 weeks must have elapsed after RP. If previously taking ADT, it should have been discontinued at least 16 weeks prior to PET.
- Participants with a clinical flotufolastat F 18 PSMA PET/CT scan prescribed as part of the standard of care management.
- Age ≥18 years.
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants currently receiving ADT (defined as surgical orchidectomy; luteinizing hormone-releasing hormone [LHRH] agonist alone [continuous or intermittent]; LHRH antagonist alone [continuous or intermittent]; administration or use of a first or second generation anti-androgen alone or in combination with an LHRH agonist/antagonist).
- Participants who are receiving any other investigational agents for this condition within five biological half-lives prior to administration of flotufolastat F 18.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to flotufolastat F 18 or other agents used in study.
- Participants receiving any of the following substances will be considered ineligible: x-ray contrast agent <24 hours prior to the flotufolastat F 18 PET and any other PET imaging agent within 24 hours or 10 half-lives, whichever is longer, prior to the flotufolastat F 18 PET/CT. As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.
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
Massachusetts General Hospital
Boston, Massachusetts, 02114
Jason Efstathiou, MD, DPhil, 617-726-5866, jefstathiou@mgb.org
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Jonathan Leeman, MD, 617-732-6452, JELEEMAN@BWH.HARVARD.EDU
About this study
Official title: A Prospective Study of Flotufolastat F 18 Positron Emission Tomography in Men With Very Low Prostate Specific Antigen Recurrence
The purpose of this study is to assess detection rate of flotufolastat F 18 positron emission tomography (PET) for low prostate specific antigen (PSA) recurrence of prostate cancer (PC) following radical prostatectomy.
Read the detailed description
This is a prospective single arm study for the use of flotufolastat F 18 PET in men with very low prostate specific antigen recurrence. The research study involves collecting flotufolastat F 18 PET images to evaluate the detection rate. Flotufolastat F 18 is a radiopharmaceutical (radioactive agent) the U.S. Food and Drug Administration (FDA) has approved. Participation in this study will be for the duration of the flotufolastat F 18 PET scan. It is expected that about 50 people will take part in this research study.
- Being tested
- Positron Emission Tomography (PET)
- Keywords
- flotufolastat F 18 positron emission tomography, low prostate specific antigen recurrence, prostate cancer
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron Emission Tomography (PET)Diagnostic test
Also called Flotufolastat F 18 PET
This is a PET scan with flotufolastat F 18 injection.
| Study group | Role | What they receive |
|---|---|---|
| Very Low Prostate Specific Antigen Recurrence | Men >18 years of age will undergo screening to confirm eligibility for this research study. Participants will receive a PET scan with flotufolastat F 18 injection on study visit 2. Receives: Diagnostic Test: Positron Emission Tomography (PET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection Rate
The detection rate is defined as the percentage of all patients scanned who have at least one positive lesion (localized correspondence between flotufolastat F 18 PET/CT imaging and the reference standard) regardless of coexisting false positive findings.
Measured: Periprocedural to date of detected lesion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start20 May 2025
- Primary completion16 Jan 2026
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- More trials run by Massachusetts General 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Responsible party
- Principal investigator, Jason Efstathiou, Massachusetts General Hospital
- Investigators
- Jason Efstathiou, MD, DPhil, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862856
- Sponsor's protocol ID
- 24-770
- Status last verified
- May 2026
- First submitted
- 20 Feb 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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: Jason Efstathiou, MD, DPhil (efstathiou@mgb.org) at 617-726-5866. 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 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Flotufolastat F 18 Positron Emission Tomography in Men With Very Low Prostate Specific Antigen Recurrence
- ClinicalTrials.gov ID
- NCT06862856
- Acronym / sponsor ID
- 24-770
- Keywords
- flotufolastat F 18 positron emission tomography, low prostate specific antigen recurrence, prostate cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Study start
- 20 May 2025 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 6 Mar 2025 (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 purpose of this study is to assess detection rate of flotufolastat F 18 positron emission tomography (PET) for low prostate specific antigen (PSA) recurrence of prostate cancer (PC) following radical prostatectomy.
Detailed description
This is a prospective single arm study for the use of flotufolastat F 18 PET in men with very low prostate specific antigen recurrence. The research study involves collecting flotufolastat F 18 PET images to evaluate the detection rate. Flotufolastat F 18 is a radiopharmaceutical (radioactive agent) the U.S. Food and Drug Administration (FDA) has approved. Participation in this study will be for the duration of the flotufolastat F 18 PET scan. It is expected that about 50 people will take part in this research study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Very Low Prostate Specific Antigen Recurrence | – | Diagnostic Test: Positron Emission Tomography (PET)Men >18 years of age will undergo screening to confirm eligibility for this research study. Participants will receive a PET scan with flotufolastat F 18 injection on study visit 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be identified and screened for eligibility via physician referral, clinic visit, or medical record review.
Key inclusion criteria (7 listed)
- Participants must have a history of localized histologically confirmed adenocarcinoma of the prostate and have received radical prostatectomy (RP) with curative intent.
- Participants must have measurable disease, defined as a non-zero PSA value post-RP that is concerning for biochemically recurrent or persistent disease, is ≤0.20 ng/mL, and obtained within 60 days of PET/CT.
- At least 6 weeks must have elapsed after RP. If previously taking ADT, it should have been discontinued at least 16 weeks prior to PET.
- Participants with a clinical flotufolastat F 18 PSMA PET/CT scan prescribed as part of the standard of care management.
- Age ≥18 years.
Key exclusion criteria (4 listed)
- Participants currently receiving ADT (defined as surgical orchidectomy; luteinizing hormone-releasing hormone [LHRH] agonist alone [continuous or intermittent]; LHRH antagonist alone [continuous or intermittent]; administration or use of a first or second generation anti-androgen alone or in combination with an LHRH agonist/antagonist).
- Participants who are receiving any other investigational agents for this condition within five biological half-lives prior to administration of flotufolastat F 18.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to flotufolastat F 18 or other agents used in study.
- Participants receiving any of the following substances will be considered ineligible: x-ray contrast agent <24 hours prior to the flotufolastat F 18 PET and any other PET imaging agent within 24 hours or 10 half-lives, whichever is longer, prior to the flotufolastat F 18 PET/CT. As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.
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 |
|---|---|---|
| Positron Emission Tomography (PET)Also: Flotufolastat F 18 PETThis is a PET scan with flotufolastat F 18 injection. | Diagnostic test | Very Low Prostate Specific Antigen Recurrence |
Primary outcome
Detection Rate
Time frame: Periprocedural to date of detected lesion
The detection rate is defined as the percentage of all patients scanned who have at least one positive lesion (localized correspondence between flotufolastat F 18 PET/CT imaging and the reference standard) regardless of coexisting false positive findings.
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 15 May 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: Jason Efstathiou, MD, DPhil (efstathiou@mgb.org) at 617-726-5866. 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.
Jason Efstathiou, MD, DPhil principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer (Adenocarcinoma) and Prostate Specific Antigen, run by Massachusetts General 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 4 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 15 May 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.
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 Jason Efstathiou, MD, DPhil (617-726-5866, jefstathiou@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection Rate (time frame: Periprocedural to date of detected lesion). 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 15 May 2026.