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

7 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to investigate the feasibility and toxicity of using prostate-specific membrane antigen-positron emission tomography (PSMA-PET) and multi-parametric magnetic resonance imagining (mpMRI) with PET-MR technology to define radiotherapy targets, while meeting all the current planning criteria.

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 data supports the effectiveness of the treatment 68Ga-HBED-CC-PSMA for prostate cancer?

Research shows that 68Ga-HBED-CC-PSMA is effective in accurately detecting the location and extent of prostate cancer, both at initial diagnosis and in cases of recurrence. This treatment is promising for imaging prostate cancer, helping doctors to better understand the spread and stage of the disease. ^{1 2 3 4 5}

Is 68Ga-PSMA-11 safe for use in humans?

Studies on 68Ga-PSMA-11, used for imaging prostate cancer, have focused on its radiation dosimetry, which measures the radiation dose absorbed by the body. These studies have been conducted in both healthy volunteers and prostate cancer patients, suggesting it is generally safe for human use. ^{6 7 8 9 10}

How is the treatment 68Ga-HBED-CC-PSMA different from other prostate cancer treatments?

68Ga-HBED-CC-PSMA is unique because it is a radiotracer used in PET/MRI scans to specifically target and visualize prostate cancer cells, helping to accurately locate and assess the extent of the cancer. This approach is different from traditional treatments as it focuses on improving diagnostic accuracy rather than directly treating the cancer. ^{1 2 3 11 12}

Research Team

Michael Repka, MD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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

Optimization of Acquisition time of 68Ga-PSMA-Ligand PET/MRI in Patients with Local and Metastatic Prostate Cancer. [2018]

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

68Ga-PSMA PET/CT Detects the Location and Extent of Primary Prostate Cancer. [2022]

3. Germany 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. [2022]

4. Japan pubmed.ncbi.nlm.nih.gov

Contribution of 5th minute and 2nd hour images to standard imaging in (68Ga)PSMA 11 PET/CT. [2021]

5. Netherlands 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. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Radiation dosimetry of [68Ga]PSMA-11 in low-risk prostate cancer patients. [2020]

7. England 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. [2023]

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

Comparison of Internal Dosimetry of 18 F-PSMA-1007 and 68 Ga-PSMA-11-HBED-CC. [2023]

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

68Ga-PSMA-11 Dynamic PET/CT Imaging in Primary Prostate Cancer. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Radiation dosimetry of (68)Ga-PSMA-11 (HBED-CC) and preliminary evaluation of optimal imaging timing. [2021]

11. Netherlands 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. [2022]

12. 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]