PET-MRI Imaging for Prostate Cancer

Overseen By Sophia Kallas

Age: 18+

Sex: Male

Trial Phase: Phase < 1

Sponsor: Northwestern University

Must not be taking: 5 alpha reductase, Androgen deprivation

Disqualifiers: Prior radiotherapy, Surgery, Chemotherapy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial evaluates whether positron emission tomography-magnetic resonance imaging (PET-MRI) using the radioactive drug radiohybrid prostate-specific membrane antigen (rhPSMA)-7.3 may help in detecting higher grade or stage disease in men with low and favorable intermediate risk prostate cancer who are candidates for active surveillance. A PET scan is a test that uses a radioactive drug and a computer to create images of how organs and tissues in the body are functioning. The radioactive drug used in this study, rhPSMA-7.3, attaches to the abnormal cells in the body at a different rate than normal cells which allows the scanner to create a detailed picture of how the body is working. An MRI scan uses strong magnets and computers to create detailed images of the soft tissue in your body. A multiparametric (mp)MRI is a type of MRI scan that creates a more detailed picture of the prostate gland. 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 cancer.

Will I have to stop taking my current medications?

The trial requires that you stop taking 5 alpha reductase inhibitors or androgen deprivation therapy at least one month before screening. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

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

Research shows that 18F-rhPSMA-7.3 PET imaging is effective in detecting prostate cancer recurrence, with high detection rates even at low PSA levels, and it often leads to changes in treatment plans for patients. Additionally, 18F-rhPSMA-7 PET imaging has been found to be more accurate than traditional imaging methods for identifying lymph node metastases in high-risk prostate cancer patients. ^{1 2 3 4 5}

Is 18F-rhPSMA-7.3 PET-MRI imaging safe for humans?

In a study with healthy volunteers, 18F-rhPSMA-7.3 was generally well tolerated, with only one mild headache reported as a possible side effect. The safety profile is considered favorable for PET imaging. ^{2 4 5 6 7}

How does PET-MRI imaging for prostate cancer differ from other treatments?

PET-MRI imaging for prostate cancer is unique because it combines positron emission tomography (PET) with magnetic resonance imaging (MRI) to provide detailed images of prostate cancer. This method uses a novel ligand, 18F-rhPSMA-7, which targets prostate-specific membrane antigen (PSMA) to improve the accuracy of detecting cancer spread compared to traditional imaging techniques. ^{1 2 4 8 9}

Research Team

Ashley Ross, MD

Principal Investigator

Northwestern University

Eligibility Criteria

Men aged 18+ with a life expectancy of at least 10 years, diagnosed with low or favorable intermediate risk prostate cancer (Gleason Grade Group 1 or 2), who have not had prior treatments for prostate cancer. They must have had a recent biopsy informed by mpMRI and be willing to undergo another biopsy. Those with certain concurrent diseases are allowed.

Inclusion Criteria

My prostate cancer is low grade (Gleason score 6 or 7).

I can understand and am willing to sign the study's consent form.

I agree to have a prostate biopsy before starting non-surgical treatment and within 90 days after a PET-MRI scan.

Exclusion Criteria

I haven't taken any experimental drugs within the last 28 days or 5 half-lives.

I have had treatments like radiotherapy or surgery for prostate cancer.

I have had a hip replacement surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive rhPSMA-7.3 intravenously and undergo PET-MRI and mpMRI of the prostate

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

Up to 90 days

Follow-up visits as needed

Treatment Details

Interventions

• rhPSMA-7.3 PET-MRI Imaging

Trial Overview The trial is testing if PET-MRI scans using rhPSMA-7.3 can better detect advanced stages of prostate cancer in men suitable for active surveillance. It compares detailed images from the radioactive drug rhPSMA-7.3 combined with MRI technology against standard diagnostic methods.

Participant Groups

Group I: Treatment (rhPSMA, PET-MRI, mpMRI) Experimental Treatment 7 Interventions

Patients receive rhPSMA-7.3 IV then undergo PET-MRI and mpMRI of the prostate on study. Patients also undergo Decipher test at screening and MRI-PET prostate biopsy or radical prostatectomy within 90 days per standard of care.

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 involving 20 patients with localized prostate cancer, prostate specific membrane antigen (PSMA) positron emission tomography (PET) demonstrated a sensitivity of 49% and a specificity of 95% for detecting tumor foci, which is slightly better than multiparametric magnetic resonance imaging (MRI) with a sensitivity of 44% and specificity of 94%.

Both imaging techniques missed a significant number of clinically significant lesions, but PSMA PET showed higher positive predictive value (85% vs. 81%) and may be beneficial when used alongside MRI to improve local staging before radical prostatectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate Specific Membrane Antigen Positron Emission Tomography May Improve the Diagnostic Accuracy of Multiparametric Magnetic Resonance Imaging in Localized Prostate Cancer. Rhee, H., Thomas, P., Shepherd, B., 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 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]

Both 18F-rhPSMA-7 and 18F-rhPSMA-7.3 have favorable radiation dosimetry profiles, with radiation exposure remaining below 5 mSv after injection, indicating their safety for clinical use in prostate cancer imaging.

18F-rhPSMA-7.3 demonstrated significantly lower uptake in the bladder and a trend towards higher uptake in tumors compared to 18F-rhPSMA-7, suggesting it may be more effective for targeting prostate cancer lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical biodistribution and dosimetry and human biodistribution comparing 18F-rhPSMA-7 and single isomer 18F-rhPSMA-7.3. Knorr, K., Oh, SW., Krönke, 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]

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 radiopharmaceutical 18F-rhPSMA-7.3 demonstrated high specificity (over 92%) for detecting pelvic lymph node metastases in newly diagnosed prostate cancer patients, meeting the prespecified specificity endpoint.

While the sensitivity for detecting these metastases was lower than expected (30% for the highest reader), it was higher in high-risk patients, and the agent was well tolerated with no serious adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic Performance and Safety of Positron Emission Tomography with 18F-rhPSMA-7.3 in Patients with Newly Diagnosed Unfavourable Intermediate- to Very-high-risk Prostate Cancer: Results from a Phase 3, Prospective, Multicentre Study (LIGHTHOUSE). Surasi, DS., Eiber, M., Maurer, T., et al.[2023]

Multiparametric MRI (mpMRI) is the preferred imaging method for detecting prostate cancer in the pelvis, but PET imaging using prostate-specific membrane antigen (PSMA) radiotracers is becoming a valuable complementary tool.

In a case study of a 59-year-old man, both mpMRI and PSMA-targeted PET imaging successfully identified residual prostate cancer, highlighting the potential of combining these imaging techniques for better detection and localization of cancer post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Unusual Case of Penile Prostate Cancer Uncovered by Multiparametric MRI and PSMA-Targeted 18F-DCFPyL PET/CT. Rowe, SP., Gorin, MA., Chu, LC., et al.[2018]

PSMA PET/MRI is a promising imaging technique for detecting primary prostate cancer, showing higher accuracy compared to traditional multiparametric MRI.

This imaging modality is also effective for restaging and detecting tumor recurrence in prostate cancer patients, even when prostate-specific antigen levels are low, although more research is needed to establish definitive recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Prostate-specific Membrane Antigen Positron Emission Tomography/Magnetic Resonance Imaging in Primary and Recurrent Prostate Cancer: A Systematic Review of the Literature. Manfredi, C., Fernández-Pascual, E., Arcaniolo, D., et al.[2022]

References

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

Prostate Specific Membrane Antigen Positron Emission Tomography May Improve the Diagnostic Accuracy of Multiparametric Magnetic Resonance Imaging in Localized Prostate Cancer. [2022]

2. 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]

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. Germany pubmed.ncbi.nlm.nih.gov

Preclinical biodistribution and dosimetry and human biodistribution comparing 18F-rhPSMA-7 and single isomer 18F-rhPSMA-7.3. [2022]

5. 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]

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

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

Diagnostic Performance and Safety of Positron Emission Tomography with 18F-rhPSMA-7.3 in Patients with Newly Diagnosed Unfavourable Intermediate- to Very-high-risk Prostate Cancer: Results from a Phase 3, Prospective, Multicentre Study (LIGHTHOUSE). [2023]

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

An Unusual Case of Penile Prostate Cancer Uncovered by Multiparametric MRI and PSMA-Targeted 18F-DCFPyL PET/CT. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

The Role of Prostate-specific Membrane Antigen Positron Emission Tomography/Magnetic Resonance Imaging in Primary and Recurrent Prostate Cancer: A Systematic Review of the Literature. [2022]