PSMA-PET/MRI for Prostate Cancer

Overseen By Trevor Royce, MD, MS, MPH

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Other malignancies, Inflammatory bowel disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for planning radiotherapy for prostate cancer using advanced imaging technology called PSMA-PET/MRI. The focus is on whether this method can safely and effectively target cancer cells. The trial includes a special scan using 68Ga-HBED-CC-PSMA, a radioactive tracer used in imaging, in addition to the usual CT scan before treatment. It seeks patients diagnosed with prostate cancer considered intermediate to high risk, according to specific medical guidelines. Those informed that their prostate cancer is at a more serious stage and who can undergo MRI scans might find this trial suitable. As a Phase 2 trial, the research measures how well the treatment works in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that PSMA-PET/MRI is safe for prostate cancer patients?

Research has shown that 68Ga-HBED-CC-PSMA is safe and well tolerated in humans. One study reported no major safety concerns, with serious side effects being rare. Another study confirmed that 68Ga-PSMA imaging serves as an important tool for diagnosing prostate cancer and maintains a strong safety record. Additionally, a trial with a similar compound, 68Ga-THP PSMA PET/CT, found it to be safe and well tolerated by patients. These findings reassure that the treatment is generally considered safe for human use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PSMA-PET/MRI technique for prostate cancer because it offers a cutting-edge way to detect cancer spread more accurately than traditional methods. Unlike standard imaging options like CT scans, this method uses a special tracer, 68Ga-HBED-CC-PSMA, to target prostate-specific membrane antigen (PSMA), which is abundant in prostate cancer cells. This can potentially lead to earlier and more precise identification of cancerous areas, allowing for tailored treatment plans. By enhancing imaging precision, this approach could improve treatment outcomes and reduce unnecessary interventions.

What evidence suggests that PSMA-PET/MRI is effective for prostate cancer?

Studies have shown that 68Ga-PSMA PET, a scan using a small amount of radioactive material, matches the effectiveness of mpMRI, a detailed imaging method, in detecting prostate cancer. In this trial, participants will receive a PSMA-PET/MRI scan along with the standard CT scan before treatment. Research indicates that combining these two scans improves the accuracy of diagnosing prostate cancer compared to using mpMRI alone. Additionally, 68Ga-PSMA PET/MRI has effectively detected prostate cancer in some cases. This combination of imaging methods can help doctors more accurately identify and target cancer areas in the prostate. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael Repka, MD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for English-speaking men with prostate adenocarcinoma that's considered intermediate or high-risk. They must have confirmed diagnosis, be able to perform daily activities (ECOG status 0-2), and agree to release personal health information. It's not suitable for those who don't meet these criteria.

Inclusion Criteria

Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information

My cancer is at an intermediate or high-risk level according to NCCN guidelines.

Subject is willing and able to comply with the protocol as determined by the Treating Investigator

Exclusion Criteria

Contraindications for MRI

I have no other cancers except for non-melanoma skin cancer or any cancer I've been free of for 5+ years.

I have been diagnosed with inflammatory bowel disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive radiation therapy guided by PSMA-PET/MRI to define target volumes

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Quality of Life Assessment

Patient-reported quality of life is measured using EPIC-26 and PCSI

5 years

What Are the Treatments Tested in This Trial?

Interventions

• 68Ga-HBED-CC-PSMA

Trial Overview The study tests if using PSMA-PET/MRI technology can help define radiotherapy targets in prostate cancer treatment without increasing toxicity, while still meeting current planning standards.

How Is the Trial Designed?

Group I: PMSA-PET/MRI Experimental Treatment 1 Intervention

Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Published Research Related to This Trial

In a study of 24 patients with primary prostate cancer, Ga-PSMA-11 PET/CT demonstrated a high detection rate of 95.8%, confirming its effectiveness in identifying cancerous lesions.

Dynamic PET/CT imaging showed that Ga-PSMA-11 accumulation in prostate cancer lesions increased over time, suggesting its potential for enhancing treatment strategies targeting PSMA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-PSMA-11 Dynamic PET/CT Imaging in Primary Prostate Cancer. Sachpekidis, C., Kopka, K., Eder, M., et al.[2022]

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]

The study involving 20 patients demonstrated that (68)Ga-PSMA PET/MRI is more effective than PET/CT for detecting recurrent prostate cancer, providing clearer images and better characterization of unclear findings.

PET/MRI resulted in lower radiation exposure compared to PET/CT, although it presented challenges in scatter correction and differences in standardized uptake values (SUVs) between the two imaging methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of PET/CT and PET/MRI hybrid systems using a 68Ga-labelled PSMA ligand for the diagnosis of recurrent prostate cancer: initial experience. Afshar-Oromieh, A., Haberkorn, U., Schlemmer, HP., et al.[2022]

The effective dose of [68Ga]PSMA-11 for imaging prostate cancer is 0.022 mSv/MBq, indicating a relatively low radiation exposure for patients.

In a study of six low-risk prostate cancer patients, the kidneys received the highest organ dose at approximately 40 mGy after a typical injection, while the eye lenses received a very low dose of 0.0051 mGy/MBq, suggesting a favorable safety profile for this imaging agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation dosimetry of [68Ga]PSMA-11 in low-risk prostate cancer patients. Sandgren, K., Johansson, L., Axelsson, J., et al.[2020]

68Ga-PSMA PET/MRI has demonstrated high diagnostic accuracy for staging primary prostate cancer, showing equivalent effectiveness to 68Ga-PSMA PET/CT in detecting critical features like extracapsular extension, seminal vesicle invasion, and lymph node metastasis.

The analysis included 27 studies, indicating that while both imaging modalities are effective, further direct comparisons are necessary to fully establish the advantages of 68Ga-PSMA PET/MRI over PET/CT in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of 68Ga-labeled Prostate-specific Membrane Antigen Ligand Positron Emission Tomography/Magnetic Resonance Imaging and Positron Emission Tomography/Computed Tomography for Primary Staging of Prostate Cancer: A Systematic Review and Meta-analysis. Ling, SW., de Jong, AC., Schoots, IG., et al.[2022]

68Ga-PSMA PET/CT is highly effective for detecting recurrent prostate cancer, identifying cancer sites in 81% of patients with rising PSA levels after treatment, and showing a 50% detection rate for PSA levels between 0.2-0.49 ng/ml.

The imaging method demonstrated no reported adverse effects, making it a safe option for patients, and it outperformed traditional imaging methods like bone scans in detecting early recurrence of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-Labeled Prostate-specific Membrane Antigen Ligand Positron Emission Tomography/Computed Tomography for Prostate Cancer: A Systematic Review and Meta-analysis. von Eyben, FE., Picchio, M., von Eyben, R., et al.[2022]

The PET tracer 18F-PSMA 1007 was found to be safe and well tolerated in both healthy volunteers and prostate cancer patients, with no serious adverse events reported during the study.

In terms of diagnostic effectiveness, 18F-PSMA 1007 demonstrated high accuracy in detecting prostate cancer, achieving a sensitivity of 80% and a positive predictive value of 100% in patients with untreated preoperative prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/IIa trial of 18F-prostate specific membrane antigen (PSMA) 1007 PET/CT in healthy volunteers and prostate cancer patients. Tateishi, U., Kimura, K., Tsuchiya, J., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11563965/

Comparison of 68Ga-PSMA PET and mpMRI for prostate ... This meta-analysis indicates that 68 Ga-PSMA PET has similar sensitivity and specificity to mpMRI in local prostate cancer staging.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1558767324000478

An Update on the Role of mpMRI and 68Ga-PSMA PET ... The findings indicated that 68Ga-PSMA-PET/CT effectively diagnosed prostate cancer in patients with suspected or confirmed disease, and both methods exhibited ...

3. jnm.snmjournals.org jnm.snmjournals.org/content/65/4/555

The Value of 68Ga-PSMA PET/MRI for Classifying Patients ... Our previous study found that the combination of mpMRI and 68Ga-PSMA PET/CT improved the diagnostic accuracy of csPCa compared with mpMRI alone, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04573179

Effectiveness of 68Ga-PSMA PET/MRI for Improving the ... The purpose of this study was to explore the effectiveness of 68Ga-PSMA PET/MRI for improving the detection of csPCa in lesions with PI-RADS score 3. This study ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32064552/

Exploratory cost-effectiveness analysis of 68Gallium-PSMA ... In this exploratory economic evaluation, using 68 Ga-PSMA PET/MRI to detect prostate cancer recurrence appears to be cost-effective relative to usual care.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8612191/

A Phase II, Open-Label Study to Assess Safety and ... This phase II, open-label prospective clinical trial showed 68 Ga-THP PSMA PET/CT to be well tolerated and safe to use.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02952469

Biodistribution/Reproducibility Ga-68 PSMA-HBED-CC The purpose of this Radioactive Drug Research Committee (RDRC) study is to collect initial data regarding biodistribution, reproducibility, and dosimetry ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5486817/

Diagnostic performance of 68Ga-PSMA-11 (HBED-CC) ... This imaging method has rapidly spread and is now regarded as a significant step forward in the diagnosis of recurrent prostate cancer (PCa).

9. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2729065

Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing ... 68 Ga-PSMA-11 PET has high positive predictive value, detection rate, and interreader agreement for localization of recurrent prostate cancer.

10. pubs.rsna.org pubs.rsna.org/doi/pdf/10.1148/radiol.204066

Safety and Diagnostic Yield of 68Ga Prostate-specific ... Conclusion: Transgluteal prostate-specific membrane antigen (PSMA) PET/CT-guided, robotic-targeted prostatic biopsy is safe with a high diagnostic yield of ...