PET/MRI Scan for Prostate Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Immunosuppressants, Chemotherapy, Hormonal therapy

Disqualifiers: Obesity, Neurologic disorder, Psychiatric disorder, others

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

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

Compensation: Varies

Number of Visits: 7

50 Participants Needed

Trial Summary

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 have been treated with immunosuppressants, chemotherapy, or hormonal therapy recently. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment 18F-rhPSMA-7.3 PET/MRI for prostate cancer?

Research shows that 18F-rhPSMA-7.3 PET imaging is more effective than traditional imaging methods in detecting prostate cancer spread to lymph nodes, with higher accuracy and sensitivity. It also offers high detection rates for early recurrence of prostate cancer, making it a valuable tool for guiding treatment decisions. ^{1 2 3 4 5}

Is 18F-rhPSMA-7.3 safe for use in humans?

18F-rhPSMA-7.3 has been shown to be generally safe in humans, with one mild headache reported as a possible side effect in a study with healthy volunteers. The safety profile is considered favorable for PET imaging. ^{1 4 6 7 8}

How does the PET/MRI scan for prostate cancer differ from other treatments?

The PET/MRI scan for prostate cancer using 18F-rhPSMA-7 or 18F-rhPSMA-7.3 is unique because it combines advanced imaging techniques to more accurately detect and stage prostate cancer, especially in identifying lymph node metastases, compared to traditional imaging methods like CT or MRI alone. This approach offers higher sensitivity and specificity, leading to better-informed treatment decisions. ^{1 2 4 5 8}

What is the purpose of this trial?

This clinical trial evaluates the use of an imaging scan (18F-rhPSMA-7.3 positron emission tomography \[PET\]/magnetic resonance imaging \[MRI\]) for identifying patients who are at risk of having their disease spread to the lymph nodes in those undergoing radical prostatectomy for prostate cancer that has not spread to other parts of the body (localized). Prostate specific membrane antigen (PSMA) PET/computed tomography (CT) has emerged as an option to stage newly diagnosed high risk prostate cancer patients. PSMA PET/CT has demonstrated improved diagnostic accuracy for identifying metastasis. PET is procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is used. Because cancer cells often use more glucose than normal cells, the pictures can be used to find cancer cells in the body. MRI is procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. This study may help researchers learn whether 18F-rhPSMA-7.3 PET/ MRI may improve predicting which patients are at risk of lymph node metastases and who are suitable candidates for pelvic lymph node dissection in patients with localized high-risk prostate cancer undergoing radical prostatectomy.

Research Team

Ram A. Pathak, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for men with high-risk prostate cancer that hasn't spread beyond the prostate. They're looking at how well a new type of PET/MRI scan can predict if the cancer has reached the lymph nodes, which could help decide if patients need further surgery to remove these nodes.

Inclusion Criteria

Patient has the willingness to comply with instruction of the investigator

Patient has the willingness to comply with follow-up surveillance

I am scheduled for a major prostate surgery with lymph node removal.

Exclusion Criteria

My BMI is over 40.

I have received hormonal therapy like Lupron or oral antiandrogens.

Has any condition(s), which seriously compromises the subject's ability to participate in this study, sign consent, or has a known history of poor adherence with medical treatment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

1 visit (in-person)

Imaging and Preoperative Assessment

Participants receive 18F-rhPSMA-7.3 intravenously and undergo PET/MRI, CT or MRI, bone scan, and tissue collection up to 30 days prior to surgery

Up to 4 weeks

1-2 visits (in-person)

Surgery

Participants undergo standard of care robotic radical prostatectomy with bilateral pelvic lymph node dissection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery at 6 weeks, 3 months, 9 months, and 12 months post-surgery

12 months

4 visits (in-person)

Treatment Details

Interventions

• 18F-rhPSMA-7.3 PET/MRI

Trial Overview The study tests an imaging technique using a radioactive substance (18F-rhPSMA-7.3) combined with PET and MRI scans to detect potential spread of prostate cancer to lymph nodes in patients who are already scheduled for radical prostatectomy.

Participant Groups

Group I: Screening (18F-rhPSMA-7.3 PET/MRI) Experimental Treatment 9 Interventions

Patients receive 18F-rhPSMA-7.3 IV and undergo PET/MRI up to 30 days prior to SOC robotic radical prostatectomy with bilateral pelvic lymph node dissection. Patients also undergo CT or MRI, bone scan and tissue collection during screening.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

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]

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 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]

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 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]

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 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]

References

1. 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]

2. 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]

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

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

4. Germany pubmed.ncbi.nlm.nih.gov

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

5. 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]

6. United States 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. [2022]

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

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

8. 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]