18F-rhPSMA-7.3 for Prostate Cancer

(SCOUT Trial)

Overseen By Oncology Clinical Research Referral Office

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Hackensack Meridian Health

Disqualifiers: Pediatric patients, Prior whole gland ablation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 year (+/- 60 days)

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special scan to detect prostate cancer recurrence after focused treatment. The scan uses 18F-rhPSMA-7.3, a radioactive tracer that highlights cancer cells in the prostate, making them easier to see. Men who underwent focal therapy for intermediate-risk prostate cancer in the last 9 months might be suitable candidates. The goal is to determine if this scan can more effectively identify cancer that returns after treatment. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance future cancer detection methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this PSMA-PET scan is safe for identifying recurrent prostate cancer?

Research has shown that 18F-rhPSMA-7.3 is safe for patients with prostate cancer. In studies involving 747 patients, each received one dose of this diagnostic tool without major safety issues. While side effects can occur with any medical treatment, the FDA approval of 18F-rhPSMA-7.3 for detecting prostate cancer suggests it is generally well-tolerated. This indicates that in past research, serious side effects were likely rare or manageable. Patients should consult their doctor to understand what this means for their individual situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 18F-rhPSMA-7.3 because it offers a new way to detect prostate cancer that targets the prostate-specific membrane antigen (PSMA). Unlike traditional imaging methods, which might miss smaller or less active lesions, this technique uses a radiohybrid approach to highlight cancer cells more effectively. This means it could help doctors find and treat prostate cancer more accurately, potentially leading to better outcomes for patients. Furthermore, it is administered as a simple intravenous injection, making it a convenient option for both patients and healthcare providers.

What evidence suggests that this PSMA-PET scan is effective for identifying recurrent prostate cancer?

Research has shown that 18F-rhPSMA-7.3, which participants in this trial will receive, effectively detects recurrent prostate cancer. Studies have found it can identify cancer in 83% of patients tested, reliably locating cancer cells with a specific marker called PSMA. The FDA has already approved this scan for detecting cancer in men with prostate cancer, supporting its ability to find cancer that returns after treatment. Overall, it is a promising tool for those with recurrent prostate cancer. ^{3 6 7 8 9}

Who Is on the Research Team?

Nitin Yerrman, MD

Principal Investigator

Hackensack Meridian Health

Are You a Good Fit for This Trial?

This trial is for adult males over 18 with intermediate risk prostate cancer who had focal therapy within the last 9 months. They should expect to live at least another 10 years, have a pre-treatment MRI, and be able to follow the study schedule including imaging and blood tests. It's not for those under 18 or treated with whole gland ablation more than 9 months ago.

Inclusion Criteria

Life Expectancy of 10 years or more

I had targeted therapy for prostate cancer within the last 9 months.

I had a biopsy with at least 2 samples from the MRI-visible lesion.

Exclusion Criteria

I am 18 years old or older.

I had a treatment to remove or destroy all or part of a gland more than 9 months ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo SOC focal therapy followed by a PSMA-PET scan using 18F-rhPSMA-7.3

1 year (+/- 60 days)

1 visit (in-person) for PET scan

Follow-up

Participants are monitored for recurrence of prostate cancer through biopsy and PET scan correlation

1 year

2 visits (in-person) for biopsies at year 1 and 3

What Are the Treatments Tested in This Trial?

Interventions

• 18F-rhPSMA-7.3

Trial Overview The trial is testing the effectiveness of a new PSMA-PET scan called 18F-rhPSMA-7.3 in detecting recurrent prostate cancer after patients received focal treatment aimed at only part of the prostate.

How Is the Trial Designed?

Group I: 18F-rhPSMA-7.3 Experimental Treatment 1 Intervention

Patients will undergo a PSMA-PET scan at 1 year (+/- 60 days) after treatment with SOC focal therapy using a radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)-targeted PET scan using 18F-rhPSMA-7.3 (Posluma). The rhPSMA-targeted PET scan is an FDA-approved PET scan to detect the presence of lesions positive for prostate-specific membrane antigen (PSMA) in men with prostate cancer. 18F-rhPSMA-7.3 (Posluma) injection is a radioactive diagnostic agent that is administered in the form of an intravenous injection.

Who Is Running the Clinical Trial?

Hackensack Meridian Health

Lead Sponsor

Trials

141

Recruited

42,900+

Blue Earth Diagnositcs

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11218719/

True-Positive 18F-Flotufolastat Lesions in Patients with ... Our data demonstrate a high likelihood of positive results ... Long-term outcomes of SBRT for PSMA PET detected oligometastatic prostate cancer.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0302283823029494

Diagnostic Performance and Safety of Positron Emission ... The efficacy population comprised all patients who underwent 18F-rhPSMA-7.3-PET/CT and subsequent RP and PLND, and was used to assess the coprimary endpoints.

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.6_suppl.009

Detection rate of 18F-rhPSMA-7.3 PET in patients with ... Together, these data support the clinical utility of 18F-rhPSMA-7.3 PET in men with recurrent prostate cancer across a wide PSA range.

4. auajournals.org auajournals.org/doi/10.1097/JU.0000000000003493

Diagnostic Performance and Safety of 18 F-rhPSMA-7.3 ... The overall 18F-rhPSMA-7.3 detection rate among all 389 patients with an evaluable scan was 83% (majority read). Among the 366 patients (median ...

5. posluma.com posluma.com/suspected-bcr/

Suspected BCR Study Data Review efficacy data from the SPOTLIGHT study in men with suspected prostate cancer recurrence. POSLUMA® (flotufolastat F 18) Injection.

6. posluma.com posluma.com/safety/

Safety Diagnostic performance and safety of 18F-rhPSMA-7.3 PET in men with suspected prostate cancer recurrence: results from a phase 3, prospective, multicenter study ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37126069/

Diagnostic Performance and Safety of 18 F-rhPSMA-7.3 ... 18 F-rhPSMA-7.3 offers a clinically meaningful verified detection rate for localization of recurrent prostate cancer.

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2023/216023s000lbl.pdf

Page 1 of 12 - accessdata.fda.gov The safety of POSLUMA was evaluated in 747 patients with prostate cancer [see Clinical Studies. (14.1,14.2)]. All patients received a single administration ...

9. jnm.snmjournals.org jnm.snmjournals.org/content/early/2024/05/23/jnumed.123.267271

True-Positive 18F-Flotufolastat Lesions in Patients with ... 18 F-flotufolastat frequently identified true-positive prostate cancer lesions in patients with negative conventional imaging.