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

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the detection of prostate cancer that has returned after surgery by using advanced PET/CT scans. The focus is on a special imaging technique with a tracer, F18-rhPSMA-7.3, and sometimes a diuretic (furosemide), to better reveal hidden cancerous areas. This could lead to earlier and more accurate treatment decisions. Men who have undergone prostate surgery and now have rising PSA levels, indicating a possible cancer return, might be good candidates for this study. As a Phase 2 trial, the research measures how well the treatment works in an initial, smaller group of people.

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 imaging technique is safe for detecting prostate cancer recurrence?

Research has shown that the 18F-rhPSMA-7.3 tracer used in PET/CT scans is generally safe for patients. In previous studies, patients who underwent scans with this tracer did not report significant side effects, and it effectively identified recurrent prostate cancer. This suggests the tracer is safe for people.

Furosemide, a medicine that increases urine flow, is also part of the trial. It helps reduce radioactivity in the bladder, making cancer detection easier. Earlier studies have shown that using furosemide with PET/CT scans is safe and well-tolerated. Patients did not experience major issues when furosemide was used, supporting its safety.

Overall, previous research has shown that both the tracer and furosemide are safe for people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of 18F-rhPSMA-7.3 in PET/CT scans for detecting prostate cancer recurrence because it targets the prostate-specific membrane antigen (PSMA), which is highly expressed in prostate cancer cells. This makes it more precise than traditional imaging techniques like standard CT or bone scans, which might miss smaller or less active cancer sites. The use of this tracer can potentially lead to earlier and more accurate detection of cancer recurrence, allowing for tailored treatment plans and better outcomes for patients. Additionally, combining it with furosemide can enhance image clarity by reducing background signal in the bladder, further improving diagnostic accuracy.

What evidence suggests that this PET/CT scan method is effective for detecting recurrent prostate cancer?

Studies have shown that 18F-rhPSMA-7.3 PET/CT scans, which participants in this trial will undergo, effectively detect recurrent prostate cancer. In a large study, these scans correctly identified cancer in 83% of patients. This method excels at detecting cancer that has spread to the lymph nodes. In this trial, using furosemide, a medication that helps empty the bladder, may enhance scan clarity by reducing background noise in the images. This could be particularly useful for spotting cancer that has returned after prostate surgery. ^{1 2 4 6 7}

Who Is on the Research Team?

Charles V. Marcus, MBBS

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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 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]

Citations

1. jnm.snmjournals.org jnm.snmjournals.org/content/61/supplement_1/1267

Preliminary data on the diagnostic efficacy of F-18-rhPSMA ... Our preliminary data from this small cohort indicate that F-18-rhPSMA-7.3 PET might be superior to morphological imaging for primary N-staging of intermediate ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9730917/

Validation of 18F-rhPSMA-7 and 18F-rhPSMA-7.3 PET ... The presented data demonstrate a high specificity and PPV of 18F-rhPSMA-7 and 18F-rhPSMA-7.3 PET for lymph node metastases in patients with ...

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

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

4. nature.com nature.com/articles/s41598-024-83074-3

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

5. 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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8844263/

Safety, Biodistribution, and Radiation Dosimetry of 18F- ... This first-in-humans study investigated the safety, biodistribution, and radiation dosimetry of a novel 18 F-labeled radiohybrid prostate-specific membrane ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05779943

Comparison of 18F-rhPSMA-7.3 PET/CT With and Without ... Adding furosemide to 18F-rhPSMA 7.3 PET/CT scans may help to better detect and treat patients with biochemically recurrent prostate cancer. Detailed Description.