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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if PET-MRI, combined with the radioactive drug rhPSMA-7.3, can better detect higher-grade prostate cancer in men with low to intermediate risk. PET-MRI creates detailed images of the prostate, potentially identifying more serious disease that other tests might miss. Men diagnosed with low or favorable intermediate-risk prostate cancer, who have had a prostate biopsy in the past 3 to 15 months, might be suitable for this study. As an Early Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking advancements in prostate cancer detection.

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 prior data suggests that PET-MRI imaging is safe for prostate cancer detection?

Research has shown that rhPSMA-7.3, the radioactive drug used in PET-MRI scans, is safe. Studies have found that its safety profile, distribution in the body, and radiation levels are acceptable for imaging. Patients have tolerated rhPSMA-7.3 well during scans, with no major safety issues reported. This makes it a promising option for detecting prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about rhPSMA-7.3 PET-MRI imaging for prostate cancer because it offers a new way to visualize cancer activity with high precision. Unlike traditional imaging methods like CT scans or bone scans, this technique combines the detailed anatomical imaging of MRI with the functional imaging of PET, specifically using the radiotracer rhPSMA-7.3. This tracer targets the prostate-specific membrane antigen (PSMA), which is often elevated in prostate cancer cells, allowing for more accurate detection and staging of the disease. This enhanced imaging capability could lead to more tailored treatment plans and potentially better outcomes for patients.

What evidence suggests that rhPSMA-7.3 PET-MRI Imaging is effective for detecting higher grade or stage prostate cancer?

Research has shown that rhPSMA-7.3, when used with PET-MRI scans, might better detect more serious prostate cancer. This radioactive drug attaches to cancer cells, creating clearer images. Participants in this trial will receive rhPSMA-7.3 and undergo PET-MRI and mpMRI of the prostate. Studies have found that 18F-rhPSMA-7.3 PET imaging can improve prostate cancer management by accurately identifying recurrent cancer. It has proven more effective than traditional imaging methods for newly diagnosed prostate cancer, suggesting it could be a valuable tool for detecting otherwise missed cases. ^{5 6 7 8 9}

Who Is on the Research Team?

Ashley Ross, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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.

Institutional Review Board (IRB)-/Independent Ethics Committee (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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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 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]

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]

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]

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]

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]

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.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05852041

rhPSMA-73 PET-MRI Imaging for the Detection of Prostate ...

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 ...

2.

pmc.ncbi.nlm.nih.gov

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

Detection Efficacy of 18F‐rhPSMA‐7.3 PET/CT and Impact ...

18 F-rhPSMA-7.3 is a novel and effective PET agent for imaging of recurrent prostate cancer, resulting in a potential management change in approximately two ...

3.

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 ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0302283823029494

Diagnostic Performance and Safety of Positron Emission ...

Radiohybrid (rh) 18F-rhPSMA-7.3 is a novel high-affinity prostate-specific membrane antigen (PSMA)-targeting radiopharmaceutical for prostate cancer (PCa) ...

5.

trialfinder.panfoundation.org

trialfinder.panfoundation.org/en-US/trial/listing/426176

rhPSMA-73 PET-MRI Imaging for the Detection of Prostate ...

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 ...

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.

pmc.ncbi.nlm.nih.gov

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

Safety, Biodistribution, and Radiation Dosimetry of 18F- ...

Conclusion: The safety, biodistribution, and internal radiation dosimetry of 18F-rhPSMA-7.3 are considered favorable for PET imaging. Keywords: 18F, ...

8.

redjournal.org

redjournal.org/article/S0360-3016(24)02982-1/fulltext

A Prospective Pilot Study Investigating 18 F rhPSMA-7.3 ...

We hypothesized that F-18 rhPSMA 7.3 PET/MRI accurately detects recurrent PCa to direct field design in salvage radiation therapy (RT) planning even at low PSA ...

9.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2021-05725

An Investigational Scan (rh PSMA 7.3 PET/MRI) for the ...

rhPSMA-7.3 is a radioactive tracer agent that when used with PET/MRI imaging may help diagnose and look for the spread of prostate cancer. Prostate-specific ...