rhPSMA-7.3 PET/CT Scan for Prostate Cancer

Overseen By Nikki Hubbard

Age: Any Age

Sex: Male

Trial Phase: Phase < 1

Sponsor: Northwestern University

Must not be taking: 5-alpha reductase, androgen deprivation

Disqualifiers: Non-metastatic castrate resistant, others

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

Compensation: Varies

Number of Visits: 2

27 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial evaluates an imaging technique (rhPSMA-7.3 positron emission tomography \[PET\]/computed tomography \[CT\]) for detecting prostate cancer in patients who have increasing prostate-specific antigen levels following prior treatment (biochemical recurrence) but who were prostate specific membrane antigen negative on their most recent PET scan. Contrast agents like rhPSMA-7.3 (also called POSLUMA) circulate in the blood until they find their intended target. Once they are taken up by the target tumor cells, they can be visualized using PET/CT cameras. A PET scan is a procedure in which a small amount of radioactive tracer (in this case rhPSMA-7.3) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the tracer is taken up. Because tumor cells often take up more tracer than normal cells, the pictures can be used to find tumor cells in the body. A CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional views of tissues and organs. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination. The researchers want to determine whether the rhPSMA7.3 PET/CT scan is useful for detecting biochemically recurrent prostate cancer in patients who were negative on prior non-POSLUMA PET imaging.

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 be on 5-alpha reductase inhibitors, androgen deprivation therapy, or androgen receptor antagonists within 3 months before joining. You can start these treatments again after the scan if your doctor advises.

What data supports the effectiveness of the treatment rhPSMA-7.3 PET/CT for prostate cancer?

Research shows that 18F-rhPSMA-7.3 PET/CT is more effective than traditional imaging methods for detecting prostate cancer spread, with high accuracy in identifying cancer in lymph nodes and other areas. It also demonstrates high detection rates in patients with recurring prostate cancer, even at low PSA levels, making it a promising tool for diagnosing and managing prostate cancer. ^{1 2 3 4 5}

Is the rhPSMA-7.3 PET/CT scan safe for humans?

In a study with healthy volunteers, the rhPSMA-7.3 PET/CT scan was generally well tolerated, with only one mild headache reported as a possible side effect. The safety profile is considered favorable for imaging purposes. ^{3 6 7 8 9}

How is the rhPSMA-7.3 PET/CT scan different from other prostate cancer treatments?

The rhPSMA-7.3 PET/CT scan is unique because it uses a novel radiopharmaceutical that targets prostate-specific membrane antigen (PSMA) for imaging, providing superior diagnostic performance compared to traditional imaging methods. It offers better detection of primary and metastatic prostate cancer lesions, especially in high-risk patients, and has a higher accuracy in identifying lymph node metastases. ^{1 2 3 4 10}

Research Team

Ashley E Ross

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for patients with prostate cancer who have rising PSA levels after treatment but were negative on previous PSMA-targeted PET scans. It's designed to see if a new scan, rhPSMA-7.3 PET/CT, can detect recurrent cancer.

Inclusion Criteria

I am a man treated for prostate cancer with local therapy.

IRB-/IEC-approved written informed consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures

I have other ongoing health conditions or cancers.

Exclusion Criteria

Most recent PSA not between 0.1ng/ml and 0.5ng/ml

I haven't taken hormone therapies for prostate issues in the last 3 months.

My prostate cancer is not spreading but my PSA levels are rising and my testosterone is low.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Imaging

Patients receive rhPSMA-7.3 intravenously and undergo PET/CT 60 minutes later on day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the diagnostic imaging

2 years

1 visit at 14 days, then every 3 months

Treatment Details

Interventions

• rhPSMA-7.3 PET/CT

Trial Overview The ENLIGHTEN trial is testing the effectiveness of an investigational imaging technique called rhPSMA-7.3 PET/CT in identifying biochemically recurrent prostate cancer that was not detected by earlier scans.

Participant Groups

Group I: Diagnostic (rhPSMA-7.3 PET/CT) Experimental Treatment 4 Interventions

Patients receive rhPSMA 7.3 IV and undergo PET/CT 60 minutes later on day 1.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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 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 prospective cohort study of men with biopsy-proven prostate cancer, 80% did not experience treatment progression after receiving treatment plans based on PSMA PET-CT results over a follow-up period of 29 months.

Men with distant nodes identified on PSMA PET-CT scans had a significantly higher risk (5 times) of treatment progression, highlighting the importance of these scans in assessing disease severity and guiding treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distant Nodes Seen on PSMA PET-CT Staging Predicts Post-Treatment Progression in Men with Newly Diagnosed Prostate Cancer-A Prospective Cohort Study. Ong, S., Pascoe, C., Kelly, BD., et al.[2022]

In a study of 202 prostate cancer patients, the biodistribution of 18F-rhPSMA-7 was found to be stable across different administered activities and uptake times, indicating its reliability as a PSMA-targeting imaging agent.

The research suggests that the best imaging time point for optimal image quality with 18F-rhPSMA-7 PET/CT is between 50-70 minutes post-injection, as this timing minimizes nonspecific blood activity and maximizes clarity for clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative and Qualitative Analyses of Biodistribution and PET Image Quality of a Novel Radiohybrid PSMA, 18F-rhPSMA-7, in Patients with Prostate Cancer. Oh, SW., Wurzer, A., Teoh, EJ., et al.[2020]

The novel 18F-labeled radiohybrid prostate-specific membrane antigen (rhPSMA) PET imaging agent, 18F-rhPSMA-7.3, was well tolerated in a study involving six healthy volunteers, with only one mild adverse event reported.

The effective dose of 18F-rhPSMA-7.3 was calculated to be 0.0141 mSv/MBq, indicating a favorable safety profile for PET imaging, with the highest radiation exposure observed in the adrenals and kidneys.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Biodistribution, and Radiation Dosimetry of 18F-rhPSMA-7.3 in Healthy Adult Volunteers. Tolvanen, T., Kalliokoski, K., Malaspina, S., et al.[2022]

The novel PET radiopharmaceutical 18F-rhPSMA-7.3 showed high uptake in prostate cancer lesions, with optimal visual detection starting at 60 minutes post-injection, indicating its potential effectiveness for imaging prostate cancer.

The study demonstrated that the lesion-to-background ratios increased significantly over time, suggesting that 18F-rhPSMA-7.3 could provide clearer imaging results for diagnosing prostate cancer, based on a phase 1 trial involving nine men with varying stages of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kinetic analysis and optimisation of 18F-rhPSMA-7.3 PET imaging of prostate cancer. Malaspina, S., Oikonen, V., Kuisma, A., 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&amp;T in Patients with Metastatic Castration-Resistant Prostate Cancer. Feuerecker, B., Chantadisai, M., Allmann, A., et al.[2023]

The novel radiopharmaceutical 18F-rhPSMA-7.3 demonstrated high efficacy in detecting prostate cancer lesions, identifying all primary tumors in high-risk localized cases and all known metastatic lesions in patients with hormone-sensitive and castration-resistant prostate cancer.

In a small study of 10 patients, 18F-rhPSMA-7.3 showed a strong correlation between the maximum standardized uptake value (SUVmax) of prostate lesions and higher Gleason scores, indicating its potential for accurately identifying more aggressive cancer types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uptake of 18F-rhPSMA-7.3 in Positron Emission Tomography Imaging of Prostate Cancer: A Phase 1 Proof-of-Concept Study. Malaspina, S., Taimen, P., Kallajoki, M., et al.[2022]

References

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

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

2. 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]

3. 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]

4. 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]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Distant Nodes Seen on PSMA PET-CT Staging Predicts Post-Treatment Progression in Men with Newly Diagnosed Prostate Cancer-A Prospective Cohort Study. [2022]

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

Quantitative and Qualitative Analyses of Biodistribution and PET Image Quality of a Novel Radiohybrid PSMA, 18F-rhPSMA-7, in Patients with Prostate Cancer. [2020]

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

Safety, Biodistribution, and Radiation Dosimetry of 18F-rhPSMA-7.3 in Healthy Adult Volunteers. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Kinetic analysis and optimisation of 18F-rhPSMA-7.3 PET imaging of prostate cancer. [2022]

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

Pretherapeutic Comparative Dosimetry of 177Lu-rhPSMA-7.3 and 177Lu-PSMA I&amp;T in Patients with Metastatic Castration-Resistant Prostate Cancer. [2023]

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

Uptake of 18F-rhPSMA-7.3 in Positron Emission Tomography Imaging of Prostate Cancer: A Phase 1 Proof-of-Concept Study. [2022]