18F-rhPSMA-7.3 PET/CT Scans for Prostate Cancer Recurrence

Recruiting at 3 trial locations

Overseen By David M. Schuster, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Emory University

Disqualifiers: Inability to undergo PET-CT, 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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial evaluates Fluorine-18 radiohybrid prostate-specific membrane antigen (18F- rhPSMA)-7.3 positron emission tomography (PET)/computed tomography (CT) scans with and without furosemide for the reduction of bladder activity in patients with prostate cancer that has come back (recurrent) based on elevated levels of prostate-specific antigen (PSA) in the blood (biochemical) after prostate surgery (prostatectomy). Furosemide is a diuretic substance that increases the urine flow into the bladder, thereby decreasing the level of radioactivity within the bladder, which may help to see any abnormal areas that could be masked by the radioactivity within the bladder. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, rhPSMA ligand. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. Adding furosemide to 18F-rhPSMA 7.3 PET/CT scans may help to better detect and treat patients with biochemically recurrent prostate cancer.

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 data supports the effectiveness of the treatment 18F-rhPSMA-7.3 PET/CT scans for detecting prostate cancer recurrence?

Research shows that 18F-rhPSMA-7.3 PET/CT scans have high detection rates for prostate cancer recurrence, even at low PSA levels, making them effective for identifying cancer that has returned after initial treatment. ^{1 2 3 4 5}

Is 18F-rhPSMA-7.3 PET/CT safe for humans?

The studies reviewed do not report any specific safety concerns or adverse effects related to the use of 18F-rhPSMA-7.3 PET/CT in humans, suggesting it is generally safe for use in detecting prostate cancer recurrence. ^{1 2 6 7 8}

How does the treatment 18F-rhPSMA-7.3 PET/CT differ from other treatments for prostate cancer recurrence?

18F-rhPSMA-7.3 PET/CT is unique because it uses a novel imaging agent that targets prostate-specific membrane antigen (PSMA) with high detection rates, even at low PSA levels, and can lead to changes in treatment plans for many patients. It offers advantages over other PSMA-targeting agents due to its longer half-life and better production scalability, making it a promising option for detecting prostate cancer recurrence. ^{1 2 4 7 9}

Research Team

Charles V. Marcus, MBBS

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Eligibility Criteria

Men over 18 with prostate cancer that has returned after surgery, evidenced by rising PSA levels. They must be able to consent, have a specific type of prostate cancer (adenocarcinoma), and normal kidney function. Men who can't undergo PET-CT scans, have conditions preventing furosemide use or suffer from urinary incontinence cannot participate.

Inclusion Criteria

I am over 18 years old.

My latest kidney test shows creatinine levels at or below 1.3 mg/dL.

Ability to provide written informed consent

Exclusion Criteria

I cannot take furosemide due to health reasons.

I experience involuntary loss of urine.

Inability to undergo 18F-rhPSMA PET-CT

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 18F-rhPSMA 7.3 tracer IV and undergo PET-CT scans with and without furosemide IV

Up to 2 weeks

Multiple visits for PET-CT scans

Follow-up

Participants are monitored for changes in bladder and renal activity, and reader confidence in identifying lesions

Up to 4 years

Treatment Details

Interventions

• Computed Tomography
• F18-rhPSMA-7.3
• Furosemide
• Positron Emission Tomography

Trial Overview The trial is testing if using the diuretic furosemide alongside a PET/CT scan with a tracer called 18F-rhPSMA-7.3 improves detection of recurrent prostate cancer by reducing bladder radioactivity and enhancing image clarity.

Participant Groups

Group I: Treatment (furosemide, F-18 rhPSMA-7.3, PET-CT) Experimental Treatment 4 Interventions

Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans with and without furosemide IV on study.

Computed Tomography is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Computed Tomography for:

• Diagnostic imaging for various conditions including cancer, cardiovascular diseases, and neurological disorders

Approved in United States as Computed Tomography for:

• Diagnostic imaging for various conditions including cancer, cardiovascular diseases, neurological disorders, and others

Approved in Canada as Computed Tomography for:

• Diagnostic imaging for various conditions including cancer, cardiovascular diseases, neurological disorders, and others

Approved in Japan as Computed Tomography for:

• Diagnostic imaging for various conditions including cancer, cardiovascular diseases, neurological disorders, and others

Approved in China as Computed Tomography for:

• Diagnostic imaging for various conditions including cancer, cardiovascular diseases, neurological disorders, and others

Approved in Switzerland as Computed Tomography for:

• Diagnostic imaging for various conditions including cancer, cardiovascular diseases, neurological disorders, and others

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Blue Earth Diagnostics

Industry Sponsor

Trials

43

Recruited

3,100+

Findings from Research

The novel theranostic ligand 18F-rhPSMA-7 demonstrated a high detection rate of 94% for recurrent prostate cancer in 97 patients who had biochemical recurrence after primary radiation therapy, even at low PSA levels.

Detection rates varied with PSA levels, achieving 100% detection for patients with PSA ≥10 ng/mL, indicating that 18F-rhPSMA-7 is effective for identifying local recurrences and metastases in prostate cancer patients post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-rhPSMA-7 PET for the Detection of Biochemical Recurrence of Prostate Cancer After Curative-Intent Radiation Therapy: A Bicentric Retrospective Study. Ilhan, H., Kroenke, M., Wurzer, A., et al.[2023]

In a study of 261 patients with biochemical recurrence of prostate cancer, 18F-rhPSMA-7 PET/CT demonstrated high detection rates of 81% for recurrent lesions, even at low PSA levels, indicating its efficacy as a diagnostic tool.

The detection rates improved with higher PSA levels, reaching 95% for patients with PSA ≥2 ng/mL, suggesting that 18F-rhPSMA-7 is particularly effective for early detection of recurrence after radical prostatectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-rhPSMA-7 PET for the Detection of Biochemical Recurrence of Prostate Cancer After Radical Prostatectomy. Eiber, M., Kroenke, M., Wurzer, A., et al.[2020]

The 18F-rhPSMA-7.3 PET/CT imaging demonstrated a high diagnostic performance for staging primary prostate cancer, identifying 98.6% of patients with local disease and showing superior sensitivity and accuracy for detecting pelvic nodal metastases compared to traditional morphologic imaging.

In a subset of patients who underwent prostatectomy, 18F-rhPSMA-7.3 PET showed a patient-level sensitivity of 66.7% and specificity of 96.6% for detecting lymph node metastases, indicating its effectiveness in accurately staging prostate cancer and distinguishing tumor activity from surrounding tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of 18F-rhPSMA-7.3 PET for Imaging of Primary Prostate Cancer and Preoperative Efficacy in N-Staging of Unfavorable Intermediate- to Very High-Risk Patients Validated by Histopathology. Langbein, T., Wang, H., Rauscher, I., et al.[2022]

In a study of 58 high-risk prostate cancer patients, 18F-rhPSMA-7 PET imaging demonstrated significantly better performance than traditional morphologic imaging (CT or MRI) for detecting lymph node metastases, with a sensitivity of 72.2% compared to 50.0%.

The accuracy of 18F-rhPSMA-7 PET was also higher, achieving 86.2% accuracy in patient-based analyses versus 65.5% for morphologic imaging, indicating its potential as a more effective tool for N-staging in prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Histologically Confirmed Diagnostic Efficacy of 18F-rhPSMA-7 PET for N-Staging of Patients with Primary High-Risk Prostate Cancer. Kroenke, M., Wurzer, A., Schwamborn, K., et al.[2020]

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 of 58 patients with recurrent prostate cancer, the PET imaging agents 18F-rhPSMA-7 and 18F-rhPSMA-7.3 demonstrated an 81.3% detection rate for lymph node metastases confirmed by histopathology, significantly outperforming traditional morphologic imaging, which only detected 12%.

The PET imaging showed a high positive predictive value of 92.4%, making it a reliable tool for identifying metastatic lymph nodes and guiding subsequent surgical interventions, such as salvage lymphadenectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of 18F-rhPSMA-7 and 18F-rhPSMA-7.3 PET Imaging Results with Histopathology from Salvage Surgery in Patients with Biochemical Recurrence of Prostate Cancer. Kroenke, M., Schweiger, L., Horn, T., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

18F-rhPSMA-7 PET for the Detection of Biochemical Recurrence of Prostate Cancer After Curative-Intent Radiation Therapy: A Bicentric Retrospective Study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

18F-rhPSMA-7 PET for the Detection of Biochemical Recurrence of Prostate Cancer After Radical Prostatectomy. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Prostate cancer imaging: what the urologist wants to know. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Utility of 18F-rhPSMA-7.3 PET for Imaging of Primary Prostate Cancer and Preoperative Efficacy in N-Staging of Unfavorable Intermediate- to Very High-Risk Patients Validated by Histopathology. [2022]

5. France pubmed.ncbi.nlm.nih.gov

Diagnosis of early biochemical recurrence after radical prostatectomy or radiation therapy in patients with prostate cancer: State of the art. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Histologically Confirmed Diagnostic Efficacy of 18F-rhPSMA-7 PET for N-Staging of Patients with Primary High-Risk Prostate Cancer. [2020]

7. United States 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Validation of 18F-rhPSMA-7 and 18F-rhPSMA-7.3 PET Imaging Results with Histopathology from Salvage Surgery in Patients with Biochemical Recurrence of Prostate Cancer. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Outcome after PSMA PET/CT based salvage radiotherapy in patients with biochemical recurrence after radical prostatectomy: a bi-institutional retrospective analysis. [2022]