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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging method, 18F-rhPSMA-7.3 PET/MRI, to better identify prostate cancer patients whose disease might spread to the lymph nodes. The goal is to determine if this scan can more accurately predict which patients need additional surgery to remove affected lymph nodes. It is ideal for men with high-risk, localized prostate cancer planning to undergo prostate surgery. Participants should have a primary diagnosis of prostate cancer, not have received recent hormonal therapy, and must be able to remain still during the scan.

As an unphased trial, this study offers patients the opportunity to contribute to pioneering research that could enhance future prostate cancer treatment strategies.

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 prior data suggests that this imaging scan is safe for identifying prostate cancer risk?

Research has shown that 18F-rhPSMA-7.3, when used with PET/MRI scans, is generally safe. A study with healthy participants found that this imaging drug was well-tolerated, with most participants experiencing no adverse side effects. The study also determined that the radiation level from 18F-rhPSMA-7.3 was safe.

Overall, early results suggest this imaging method is both effective and safe for detecting cancerous tissues in the body. However, discussing any concerns with a healthcare provider before joining a clinical trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 18F-rhPSMA-7.3 PET/MRI scan because it offers a new way to detect prostate cancer more precisely. Unlike standard imaging techniques like CT or bone scans, this method uses a special radioactive tracer, 18F-rhPSMA-7.3, which binds specifically to prostate cancer cells. This can lead to clearer images and potentially identify cancer spread that might be missed by current methods. By improving the accuracy of cancer detection, this technique could help doctors plan more effective treatments for patients.

What evidence suggests that the 18F-rhPSMA-7.3 PET/MRI scan is effective for identifying lymph node metastases in prostate cancer?

Research has shown that 18F-rhPSMA-7.3 PET/MRI, which participants in this trial will undergo, is promising for detecting prostate cancer that might spread to the lymph nodes. One study found that this imaging method correctly identified cancer in about 72 out of 100 cases, indicating a sensitivity of 72.2%. It also correctly ruled out cancer in about 93 out of 100 cases, demonstrating a specificity of 92.5%. Another report showed that 15 out of 16 patients had accurate positive scans, resulting in a positive predictive value (PPV) of 93.75%. This means the scan is very reliable in confirming cancer when it shows a positive result. Overall, these findings suggest that 18F-rhPSMA-7.3 PET/MRI could be a useful tool for identifying patients at risk of cancer spreading. ^{4 6 7 8 9}

Who Is on the Research Team?

Ram A. Pathak, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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/MRI or bone scan/PT, as well as tissue collection during screening.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

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 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]

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 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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07220720

POSLUMA® (18F-rhPSMA-7.3) PET-CT for PIRADS 2/3 ... The goal of this study to determine if using the (18)F-rhPSMA-7.3 PET-CT scan can improve the ability to spot serious prostate cancer in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7198390/

Histologically Confirmed Diagnostic Efficacy of 18F ... Here, we present data from a retrospective analysis using PET/CT and PET/MRI examinations to investigate the efficacy of 18F-rhPSMA-7 PET for primary N-staging ...

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

Utility of 18F-rhPSMA-7.3 PET for Imaging of Primary ... Kroenke et al. reported the patient-level sensitivity, specificity, and accuracy of 18F-rhPSMA-7 PET to be 72.2%, 92.5%, and 86.2%, respectively ...

4. 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.

5. urologytimes.com urologytimes.com/view/18f-rhpsma-7-3-pet-mri-demonstrates-high-detection-in-recurrent-prostate-cancer

18F rhPSMA-7.3 PET/MRI demonstrates high detection in ... Overall, 15/16 patients had a true positive scan based on confirmatory imaging and/or biopsy, equating to a PPV of 93.75%.

6. 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 ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0360301624029821

A Prospective Pilot Study Investigating 18F rhPSMA-7.3 ... This is a prospective phase II pilot study enrolling men with biochemical recurrence (BCR) after prostatectomy for PCa who underwent rhPSMA 7.3 ...

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

Safety, Biodistribution, and Radiation Dosimetry of 18F- ... The present data acquired in healthy subjects indicate that 18F-rhPSMA-7.3 is a well-tolerated PET radiopharmaceutical with a favorable radiation dosimetry ...

9. europeanurology.com europeanurology.com/article/S0302-2838(23)02949-4/fulltext

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 ...