PET Scan Agent for Prostate Cancer

Overseen By AdventHealth AdventHealth Oncology Research

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: AdventHealth

Must not be taking: Androgen deprivation therapy

Disqualifiers: X-ray contrast, Other PET radiotracer, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 25

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a PET scan agent called Posluma (18F-rhPSMA-7.3) to evaluate its effectiveness in detecting prostate cancer after surgery, even when PSA levels are very low. The goal is to enhance cancer detection for individuals who have undergone surgery but still exhibit low PSA levels. Ideal participants are those who have had prostate surgery and have PSA levels between 0.1 and 0.5 ng/ml. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people, offering participants an opportunity to contribute to advancements in prostate cancer detection.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently receiving Androgen Deprivation Therapy (ADT).

What prior data suggests that this PET scan agent is safe for prostate cancer detection?

In a previous study, researchers examined the safety of 18F-rhPSMA-7.3, also known as Posluma, in people with prostate cancer. The study found that this PET scan agent is generally well-tolerated, with most participants not experiencing serious problems. While some side effects might occur, the study did not report any severe issues.

Posluma is already approved by the FDA for detecting prostate cancer, indicating it has undergone safety testing in other studies. Although individual responses may vary, current evidence suggests that Posluma is a safe option for imaging prostate cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Unlike the standard imaging options for prostate cancer, which often include MRI and CT scans, 18F-rhPSMA-7.3 (Posluma) is a PET scan agent that targets the PSMA protein, which is commonly found in prostate cancer cells. This targeted approach allows for more precise imaging of prostate cancer, potentially identifying tumors that might be missed by other methods. Researchers are excited about Posluma because it promises greater accuracy in detecting prostate cancer spread, which could lead to better treatment planning and outcomes for patients.

What evidence suggests that this PET scan agent is effective for detecting prostate cancer?

Research shows that 18F-rhPSMA-7.3, also known as Posluma, effectively detects prostate cancer. In studies, this PET scan agent often identified cancer spots that regular imaging missed. Participants in this trial will receive a PET scan with 18F-rhPSMA-7.3 (Posluma) to evaluate its effectiveness. Patients with potential cancer recurrence had better outcomes when Posluma was used to help plan their treatment. This suggests Posluma could be very useful for detecting prostate cancer, especially when PSA levels are low after surgery. Overall, Posluma has shown strong promise in improving the detection and management of prostate cancer. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for men who have had surgery to remove prostate cancer and now have low but rising PSA levels, suggesting the cancer might be coming back. Participants should not have received any other post-surgery cancer treatments.

Inclusion Criteria

An elevated PSA test result that is greater than or equal to 0.1 ng/ml and less than 0.5

I had surgery to remove prostate cancer aimed at curing it.

Exclusion Criteria

I am scheduled for an x-ray or PET scan with a contrast agent within 24 hours before my PSMA-PET scan.

I am currently on hormone therapy for prostate cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

PET Scan

Participants receive a PET scan with 18F-rhPSMA-7.3 to detect prostate cancer

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the PET scan

24 months

Safety follow-up call within 24 hours of each injection/scan

What Are the Treatments Tested in This Trial?

Interventions

• 18F-rhPSMA-7.3 (Posluma)

Trial Overview

The study is testing Posluma (18F-rhPSMA-7.3), a radioactive agent used in PET scans, to see if it can detect returning prostate cancer at very low PSA levels after previous surgery.

How Is the Trial Designed?

Group I: Open Label Main Arm Experimental Treatment 1 Intervention

Single Arm receiving PET scan with 18F-rhPSMA-7.3 (Posluma)

18F-rhPSMA-7.3 (Posluma) is already approved in United States for the following indications:

Approved in United States as Posluma 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 or with suspected recurrence based on elevated serum PSA level.

Who Is Running the Clinical Trial?

AdventHealth

Lead Sponsor

Trials

118

Recruited

31,800+

Blue Earth Diagnostics

Industry Sponsor

Trials

43

Recruited

3,100+

Published Research Related to This Trial

Flotufolastat F 18 (POSLUMA®) is a newly approved imaging agent specifically designed for detecting prostate cancer lesions using PET scans, particularly in men with suspected metastasis or recurrence.

The approval in May 2023 marks a significant milestone in prostate cancer diagnostics, allowing for better identification of PSMA positive lesions in patients who are candidates for definitive therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flotufolastat F 18: Diagnostic First Approval. Heo, YA.[2023]

18F-DCFPyL (piflufolastat F 18) is the first PSMA-targeted PET agent approved for imaging prostate cancer, demonstrating high affinity for PSMA and becoming the standard-of-care for primary staging and recurrent disease.

The approval of 18F-DCFPyL was based on two significant multi-center trials, OSPREY and CONDOR, which focused on high-risk primary staging and biochemical recurrence, respectively, highlighting its efficacy in identifying prostate cancer metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image acquisition and interpretation of 18F-DCFPyL (piflufolastat F 18) PET/CT: How we do it. Rowe, SP., Voter, AF., Werner, RA., et al.[2023]

In a study of 235 patients undergoing F-18 PSMA PET imaging for prostate cancer, 65.5% had PSMA-avid lesions detected, indicating its effectiveness in identifying cancer spread.

The imaging led to changes in treatment plans for 54.5% of patients in the initial staging group and 33.9% in the biochemical recurrence group, demonstrating its significant impact on clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of piflufolastat F-18 PSMA PET imaging on clinical decision-making in prostate cancer across disease states: A retrospective review. Arafa, AT., Jain, A., Skrobanek, P., et al.[2023]

The new PET agent 18F-DCFPyL, which targets prostate-specific membrane antigen (PSMA), has shown superior diagnostic accuracy compared to conventional imaging methods for staging and restaging prostate cancer, as demonstrated in the OSPREY and CONDOR clinical trials.

The use of PSMA-PET imaging is expected to significantly enhance prostate cancer management and may lead to new diagnostic and therapeutic opportunities, improving overall patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Piflufolastat F-18 (18F-DCFPyL) for PSMA PET imaging in prostate cancer . Voter, AF., Werner, RA., Pienta, KJ., et al.[2022]

In a study of 242 patients with biochemical recurrence after prostate surgery, 18F-rhPSMA-7.3 PET/CT demonstrated a high detection rate of 72.7%, with efficacy increasing with higher PSA levels, reaching 95.7% for PSA ≥2 ng/mL.

The use of 18F-rhPSMA-7.3 PET/CT led to a change in therapeutic management for 63.2% of patients, indicating its significant impact on clinical decision-making prior to salvage therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection efficacy of 18F-rhPSMA-7.3 PET/CT and impact on patient management in patients with biochemical recurrence of prostate cancer after radical prostatectomy and prior to potential salvage treatment. Rauscher, I., Karimzadeh, A., Schiller, K., et al.[2022]

In a study involving six patients with metastatic castration-resistant prostate cancer, 177Lu-rhPSMA-7.3 demonstrated significantly higher tumor uptake compared to 177Lu-PSMA I&T, with absorbed doses to tumors being 2-3 times greater for rhPSMA-7.3.

Despite higher absorbed doses to normal organs with 177Lu-rhPSMA-7.3, the therapeutic index (TI) for both radiopharmaceuticals was similar, suggesting that rhPSMA-7.3 could provide effective treatment with potentially lower injected activity, enhancing radiation safety for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pretherapeutic Comparative Dosimetry of 177Lu-rhPSMA-7.3 and 177Lu-PSMA I&T in Patients with Metastatic Castration-Resistant Prostate Cancer. Feuerecker, B., Chantadisai, M., Allmann, A., et al.[2023]

The preclinical study demonstrated that 19F/177Lu-rhPSMA-7.3 has significantly higher tumor uptake and retention compared to the established treatment 177Lu-PSMA I&T, suggesting it may be more effective for targeting prostate cancer.

In terms of safety, 19F/177Lu-rhPSMA-7.3 showed similar clearance kinetics and radiation doses to healthy organs as 177Lu-PSMA I&T, while providing a greater reduction in tumor size and improved survival rates in treated mice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Preclinical Biodistribution, Dosimetry, and Endoradiotherapy in Metastatic Castration-Resistant Prostate Cancer Using 19F/177Lu-rhPSMA-7.3 and 177Lu-PSMA I&T. Yusufi, N., Wurzer, A., Herz, M., et al.[2022]

Citations

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

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F-Flotufolastat and 18F-rhPSMA-7 PET-guided SRT result in favorable disease outcomes in patients with biochemical recurrence of prostate cancer ...

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We present results of predefined exploratory endpoints from SPOTLIGHT to evaluate the impact of clinical factors on 18 F-flotufolastat detection rates (DR).

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posluma.com

posluma.com/POSLUMA_Clinical_Summary.pdf

POSLUMA® (flotufolastat F 18) injection

The efficacy and safety of POSLUMA were evaluated in two studies, one each in men with newly diagnosed prostate cancer and biochemical ...

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posluma.com

posluma.com/safety/

Safety

Diagnostic performance and safety of 18F-rhPSMA-7.3 PET in patients with newly diagnosed prostate cancer: results from a phase 3, prospective, multicenter study ...

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accessdata.fda.gov

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

Page 1 of 12 - accessdata.fda.gov

Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues.

8.

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.

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mayoclinic.org

mayoclinic.org/drugs-supplements/flotufolastat-f-18-intravenous-route/description/drg-20551214

Flotufolastat f 18 (intravenous route) - Side effects & uses

Flotufolastat F 18 injection is used with a PET scan (positron emission tomography) of prostate-specific membrane antigen (PSMA) positive lesions in men with ...