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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging method called rhPSMA-7.3 PET/CT to detect prostate cancer that has returned after treatment. It targets men with rising prostate-specific antigen (PSA) levels who did not show cancer on recent PET scans. The goal is to determine if this new scan can detect cancer more effectively. Men who have undergone prostate cancer treatment and now have a PSA level between 0.1 and 0.5 ng/ml might be suitable candidates. As an Early Phase 1 trial, this research aims to understand how this new imaging method works in people, offering participants the opportunity to be among the first to benefit from cutting-edge technology.

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 prior data suggests that this imaging technique is safe for detecting prostate cancer?

Research shows that the rhPSMA-7.3 PET/CT scan is generally easy for patients to handle. Studies have found that this method effectively detects recurrent prostate cancer, and patients usually experience only minor side effects. In past research, patients who underwent this scan did not report any major negative effects, suggesting its safety. Although this trial is still in the early stages, existing data from other studies suggest that rhPSMA-7.3 PET/CT is likely safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about rhPSMA-7.3 PET/CT scans for prostate cancer because they offer a new way to detect the disease more accurately. Unlike traditional imaging methods, this technique uses a special tracer, rhPSMA-7.3, which binds to prostate-specific membrane antigen (PSMA) that is often overexpressed in prostate cancer cells. This means it could potentially identify cancer spread earlier and more precisely. By improving detection, this approach might help tailor treatments more effectively for patients, leading to better outcomes.

What evidence suggests that the rhPSMA-7.3 PET/CT scan is effective for detecting prostate cancer?

Research has shown that the rhPSMA-7.3 PET/CT scan, which participants in this trial will undergo, effectively detects prostate cancer. Studies have found that this scan identifies cancer in 83% of patients whose cancer has returned, demonstrating its effectiveness in most cases. This method uses a special radioactive substance that targets prostate cancer cells, enhancing accuracy compared to some other scans. By combining PET and CT scans, it provides clearer images, aiding doctors in identifying cancer cells more easily. Overall, rhPSMA-7.3 PET/CT shows promise for accurately detecting recurrent prostate cancer. ^{2 3 6 7 8}

Who Is on the Research Team?

Ashley E Ross

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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 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]

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 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 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 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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8612184/

Detection Efficacy of 18F‐rhPSMA‐7.3 PET/CT and Impact ... Conclusion: 18F-rhPSMA-7.3 PET offered high detection efficacy in patients with biochemical recurrence after radical prostatectomy and before potential salvage ...

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

Diagnostic Performance and Safety of Positron Emission ... Data on 18F-rhPSMA-7.3 were reported from the phase 3 prospective, multicentre LIGHTHOUSE study (NCT04186819). Outcome measurements and statistical analysis.

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 ... Results: The overall DR in the 389 men (median [range] PSA, 1.10 [0.03-134.6] ng/mL) who had an evaluable 18F-rhPSMA-7.3 scan is 83% by majority ...

4. jnm.snmjournals.org jnm.snmjournals.org/content/63/9/1334

Utility of 18F-rhPSMA-7.3 PET for Imaging of Primary ... 18 F-rhPSMA-7.3 PET offers diagnostic performance superior to morphologic imaging for primary N-staging of newly diagnosed PCa, shows lower interreader ...

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

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

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37414702/

Diagnostic Performance and Safety of Positron Emission ... Overall, 18F-rhPSMA-7.3-PET/CT was well tolerated, and identified N1 and M1 disease prior to surgery in newly diagnosed PCa patients. Patient ...

7. jnm.snmjournals.org jnm.snmjournals.org/content/65/4/540

PSMA PET AUC Updates: Inclusion of rh-PSMA-7.3 Diagnostic performance and safety of 18 F-rhPSMA-7.3 positron emission tomography in men with suspected prostate cancer recurrence: results from ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05852041

Study Details | NCT05852041 | rhPSMA-73 PET-MRI ... Using rhPSMA-73 with PET-MRI and mpMRI may be more effective in detecting higher grade or stage disease in men with low and favorable intermediate risk prostate ...