Prostate Cancer (Post Prostatectomy)Phase 2NCT06617481
PET Scan Study to Detect Prostate Cancer in Patients with Early PSA Recurrence
A Phase 2 study testing 18F-rhPSMA-7.3 (Posluma) in people with Prostate Cancer (Post Prostatectomy), run by AdventHealth at 1 site in United States.
Trial summary
Flotufolastat F-18, sold under the brand name Posluma, is a radioactive diagnostic agent for use with positron emission tomography (PET) imaging for prostate cancer. The research is being done to study the capability of 18F-rhPSMA-7.3 (flotufolastat F-18) PET scan to detect prostate cancer when there are very low… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Post Prostatectomy)
- What is being tested?
- 18F-rhPSMA-7.3 (Posluma)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2024to 10 Oct 2027
- Phase
- Phase 2
- 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
- History of localized adenocarcinoma of the prostate with prior curative intent radical prostatectomy.
- An elevated PSA test result that is greater than or equal to 0.1 ng/ml and less than 0.5
Who cannot join
- Patients who are planned to have an x-ray contrast agent or other PET radiotracer \& less than 24 hours prior to the flotufolastat F-18 PSMA-PET scan.
- Patients currently receiving Androgen Deprivation Therapy (ADT).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
AdventHealth AdventHealth Oncology Research contact
United States1 site, 1 recruiting
- Recruiting
AdventHealth
Orlando, Florida, 32804
AdventHealth AdventHealth Oncology Research, 407-303-2090, CFD.ResearchOncology@AdventHealth.com
Guru Sonpavde, MD, MD
About this study
Official title: RhPSMA-7.3(18F)-PET Scan to Detect Prostate Cancer in Patients with Early PSA Recurrence
Flotufolastat F-18, sold under the brand name Posluma, is a radioactive diagnostic agent for use with positron emission tomography (PET) imaging for prostate cancer.
The research is being done to study the capability of 18F-rhPSMA-7.3 (flotufolastat F-18) PET scan to detect prostate cancer when there are very low levels of Prostate-Specific Antigen (PSA) following previous radical prostatectomy surgery.
Read the detailed description
This is not an investigational study drug. Flotufolastat PET scan is FDA Approved for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy and those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. In this research study, the flotufolastat-PET scan will be repeated if the initial scan does not show cancer and if PSA further rises by greater than 0.1 ng/ml. Other currently used scans for this purpose do not detect cancer in all patients with low levels of rising PSA.
- Conditions
- Prostate Cancer (Post Prostatectomy)
- Being tested
- 18F-rhPSMA-7.3 (Posluma)
- Keywords
- Rising PSA following cancer prostatectomy surgery
- 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-rhPSMA-7.3 (Posluma)Drug
PET Scan using Posluma for detection of early recurrence of prostate cancer.
| Study group | Role | What they receive |
|---|---|---|
| Open Label Main Arm | Other | Single Arm receiving PET scan with 18F-rhPSMA-7.3 (Posluma) Receives: Drug: 18F-rhPSMA-7.3 (Posluma) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer Detection Rate
Patients who undergo at least one rhPSMA-7.3 (18F) PET-scan will be analyzed for the primary endpoint. The malignant lesion detectability rate will be summarized using percentage and 95% confidence interval estimates overall and for those who underwent a single scan or both scans. The diagnostic evaluation aims to identify individuals who are most likely to have an isolated local relapse, as they have the most significant potential for achieving long-term disease control through additional local therapy.
Measured: 24 months
Secondary outcomes (4)
Correlation with biopsy
In those patients who undergo biopsy of a lesion, correlation with pathology report diagnosis will be reviewed.
Measured: 24 months
Correlation with other imaging modalities
In those patients who undergo other imaging modalities to confirm the results of the rhPSMA-7.3 (18F) PET-scan, correlation with other imaging modalities will be reviewed.
Measured: 24 months
Response to therapy
In those patients who undergo cancer directed therapy with radiation alone or with androgen deprivation therapy, the follow-up PSA test values after therapy will be reported.
Measured: 24 months
Adverse Events
Safety and toxicity data will be collected to evaluate any patient reported adverse effects. Safety Follow-up Call Within 24 hours of each Injection/Scan
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start20 Sep 2024
- Primary completion5 Sep 2027 (estimated)
- Study completion10 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Post Prostatectomy)Studies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617481
- Sponsor's protocol ID
- AdventH
- Other IDs
- IRBNet # 2067493
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Decision to be made at the end of enrollment period of 30 patients
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RhPSMA-7.3(18F)-PET Scan to Detect Prostate Cancer in Patients with Early PSA Recurrence
- ClinicalTrials.gov ID
- NCT06617481
- Acronym / sponsor ID
- AdventH
- Conditions
- Prostate Cancer (Post Prostatectomy)
- Keywords
- Rising PSA following cancer prostatectomy surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 5 Sep 2027 (estimated)
- Study completion
- 10 Oct 2027 (estimated)
- First posted
- 27 Sep 2024 (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.
Flotufolastat F-18, sold under the brand name Posluma, is a radioactive diagnostic agent for use with positron emission tomography (PET) imaging for prostate cancer.
The research is being done to study the capability of 18F-rhPSMA-7.3 (flotufolastat F-18) PET scan to detect prostate cancer when there are very low levels of Prostate-Specific Antigen (PSA) following previous radical prostatectomy surgery.
Detailed description
This is not an investigational study drug. Flotufolastat PET scan is FDA Approved for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy and those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. In this research study, the flotufolastat-PET scan will be repeated if the initial scan does not show cancer and if PSA further rises by greater than 0.1 ng/ml. Other currently used scans for this purpose do not detect cancer in all patients with low levels of rising PSA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label Main Arm | Other | Drug: 18F-rhPSMA-7.3 (Posluma)Single Arm receiving PET scan with 18F-rhPSMA-7.3 (Posluma) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History of localized adenocarcinoma of the prostate with prior curative intent radical prostatectomy.
- An elevated PSA test result that is greater than or equal to 0.1 ng/ml and less than 0.5
Key exclusion criteria (2 listed)
- Patients who are planned to have an x-ray contrast agent or other PET radiotracer \& less than 24 hours prior to the flotufolastat F-18 PSMA-PET scan.
- Patients currently receiving Androgen Deprivation Therapy (ADT).
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-rhPSMA-7.3 (Posluma)PET Scan using Posluma for detection of early recurrence of prostate cancer. | Drug | Open Label Main Arm |
Primary outcome
Cancer Detection Rate
Time frame: 24 months
Patients who undergo at least one rhPSMA-7.3 (18F) PET-scan will be analyzed for the primary endpoint. The malignant lesion detectability rate will be summarized using percentage and 95% confidence interval estimates overall and for those who underwent a single scan or both scans. The diagnostic evaluation aims to identify individuals who are most likely to have an isolated local relapse, as they have the most significant potential for achieving long-term disease control through additional local therapy.
4 secondary outcomes
Correlation with biopsy
Time frame: 24 months
Correlation with other imaging modalities
Time frame: 24 months
Response to therapy
Time frame: 24 months
Adverse Events
Time frame: 24 hours
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 24 Oct 2024.
- Individual participant dataSharing planned: Undecided. Decision to be made at the end of enrollment period of 30 patients
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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.
AdventHealth AdventHealth Oncology Research contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F-rhPSMA-7.3 (Posluma) in people with Prostate Cancer (Post Prostatectomy), run by AdventHealth 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 2 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: looking for participants now, as of the sponsor's last update on 24 Oct 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 AdventHealth AdventHealth Oncology Research (407-303-2090, CFD.ResearchOncology@AdventHealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer Detection Rate (time frame: 24 months). 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 24 Oct 2024.