Sodium MRI + PSMA PET for Prostate Cancer

(IGPC-5 Trial)

Overseen By Clinical Research Associate: Mena Gaed

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Glenn Bauman

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: 1

45 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial helps doctors see where prostate cancer is and how aggressive it might be in men scheduled for surgery. By measuring certain features in the prostate, these methods aim to improve treatment decisions and reduce unnecessary treatments.

Will I have to stop taking my current medications?

The trial requires that you stop taking 5-alpha reductase inhibitors, like finasteride or dutasteride, at least 6 months before starting. If you are on these medications, you will need a 6-month period without them before joining the study.

What data supports the effectiveness of the treatment involving [18F]PSMA-1007 Injection, [F-18]-DCFPyL Injection, Multiparametric MRI, and Sodium MRI for prostate cancer?

Research shows that using 18F-PSMA-1007 PET/MRI and [(18)F]DCFPyL PET/CT can improve the detection of prostate cancer lesions compared to traditional imaging methods, making them useful for staging and treatment planning in prostate cancer patients. ^{1 2 3 4 5}

Is Sodium MRI + PSMA PET safe for humans?

Studies on [18F]PSMA-1007 and [F-18]-DCFPyL, which are used in PSMA PET imaging for prostate cancer, have shown that these tracers are generally safe in humans, with evaluations focusing on safety, distribution in the body, and radiation exposure. ^{1 6 7 8 9}

How does the Sodium MRI + PSMA PET treatment for prostate cancer differ from other treatments?

The Sodium MRI + PSMA PET treatment is unique because it combines advanced imaging techniques to provide detailed anatomical and metabolic information about prostate cancer. This approach allows for more precise detection and staging of the cancer compared to traditional imaging methods, potentially leading to better-informed treatment decisions. ^{2 4 5 10 11}

Research Team

Stephen Pautler, MD, FRCSC

Principal Investigator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Eligibility Criteria

Men aged 18+ with confirmed prostate cancer who are planning to have their prostates surgically removed. They must be able to undergo multiple pre-surgery imaging tests and not have severe kidney disease, metal in the eye area, recent use of certain medications for urinary issues, or any condition that makes MRI unsafe.

Inclusion Criteria

Provision of informed consent for this study

I am a man aged 18 or older.

I am eligible for and have agreed to undergo surgery to remove my prostate.

Exclusion Criteria

I have previously received treatment for prostate cancer.

Post-void residual urine volume > 150 cc (determined by post-void ultrasound)

I have severe kidney disease or am on dialysis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Imaging

Participants undergo a series of pre-operative multi-modality imaging studies including mpMRI, sodium MRI, and PSMA PET

6 weeks

1 imaging session

Surgery and Pathology Correlation

Participants undergo radical prostatectomy, and imaging results are correlated with pathology findings

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years

Treatment Details

Interventions

• [18F]PSMA-1007 Injection
• [F-18]-DCFPyL Injection
• Multiparametric MRI
• Sodium MRI

Trial Overview The trial is testing a combination of advanced imaging techniques (Multiparametric MRI, Sodium MRI, and PET scans using [18F]PSMA-1007) before prostate removal surgery. The goal is to see how well these images predict the exact location and severity of the cancer compared to actual surgical findings.

Participant Groups

Group I: Multi-modality prostate cancer imaging Experimental Treatment 4 Interventions

The study requires eligible patients to complete one imaging session at St. Joseph's Health Care to begin within 6 weeks of the scheduled Radical Prostatectomy. Imaging will consist of simultaneous multiparametric MRI (mpMRI), sodium MRI and positron emission tomography (PET) with a radio-labeled probe for prostate-specific membrane antigen (PSMA).

Who Is Running the Clinical Trial?

Glenn Bauman

Lead Sponsor

Trials

2

Recruited

60+

University of Western Ontario, Canada

Collaborator

Trials

168

Recruited

320,000+

Western University, Canada

Collaborator

Trials

270

Recruited

62,500+

Centre for Probe Development and Commercialization

Collaborator

Trials

7

Recruited

3,300+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Findings from Research

The novel PSMA-targeted PET radiotracer [(18)F]DCFPyL detected 139 sites of metastatic prostate cancer in patients, significantly outperforming conventional imaging modalities (CIM), which only identified 45 lesions.

This study suggests that [(18)F]DCFPyL PET imaging is more effective in identifying metastatic disease, especially in cases where CIM results were negative or equivocal, highlighting its potential as a superior diagnostic tool for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PSMA-Based [(18)F]DCFPyL PET/CT Is Superior to Conventional Imaging for Lesion Detection in Patients with Metastatic Prostate Cancer. Rowe, SP., Macura, KJ., Mena, E., et al.[2022]

The study demonstrated that a comprehensive whole-body 18F-PSMA-1007-PET/MRI protocol is feasible and reproducible for imaging prostate cancer in eight high-risk patients, effectively detecting dominant lesions and providing complementary staging information.

The results showed strong correlation between SUVmean values from PET/CT and PET/MRI, indicating that this combined imaging approach can enhance the accuracy of prostate cancer assessment while minimizing artifacts, thus improving patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous whole-body 18F-PSMA-1007-PET/MRI with integrated high-resolution multiparametric imaging of the prostatic fossa for comprehensive oncological staging of patients with prostate cancer: a pilot study. Freitag, MT., Kesch, C., Cardinale, J., et al.[2019]

In a pilot study of 62 patients with suspected or defined prostate cancer, PSMA-PET/MRI imaging led to a change in management strategies for 41.9% of patients, indicating its potential clinical utility in guiding treatment decisions.

The most significant impact of PSMA-PET/MRI was observed in patients with biochemical recurrent prostate cancer, particularly those with PSA levels between 0.5 and 1 ng/ml, suggesting that this imaging technique can help refine treatment approaches in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Utility of 18F-PSMA-1007 Positron Emission Tomography/Magnetic Resonance Imaging in Prostate Cancer: A Single-Center Experience. Liu, A., Zhang, M., Huang, H., 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]

The study of [(18)F]DCFPyL in nine prostate cancer patients showed that it is safe, with no major adverse events related to the radiotracer observed during the imaging process.

[(18)F]DCFPyL demonstrated high accumulation in prostate cancer sites, indicating effective targeting for imaging, and its radiation dose is comparable to other PET radiotracers, making it a viable option for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Evaluation of [(18)F]DCFPyL for Prostate-Specific Membrane Antigen (PSMA)-Targeted PET Imaging of Prostate Cancer. Szabo, Z., Mena, E., Rowe, SP., et al.[2022]

18F-DCFPyL (piflufolastat F 18) is the first PSMA-targeted PET agent approved for imaging prostate cancer, demonstrating high affinity for PSMA and becoming the standard-of-care for primary staging and recurrent disease.

The approval of 18F-DCFPyL was based on two significant multi-center trials, OSPREY and CONDOR, which focused on high-risk primary staging and biochemical recurrence, respectively, highlighting its efficacy in identifying prostate cancer metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image acquisition and interpretation of 18F-DCFPyL (piflufolastat F 18) PET/CT: How we do it. Rowe, SP., Voter, AF., Werner, RA., et al.[2023]

References

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

PSMA-Based [(18)F]DCFPyL PET/CT Is Superior to Conventional Imaging for Lesion Detection in Patients with Metastatic Prostate Cancer. [2022]

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

Comparison of PSMA-based 18F-DCFPyL PET/CT and pelvic multiparametric MRI for lesion detection in the pelvis in patients with prostate cancer. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Variability of radiotherapy volume delineation: PSMA PET/MRI and MRI based clinical target volume and lymph node target volume for high-risk prostate cancer. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Simultaneous whole-body 18F-PSMA-1007-PET/MRI with integrated high-resolution multiparametric imaging of the prostatic fossa for comprehensive oncological staging of patients with prostate cancer: a pilot study. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Utility of 18F-PSMA-1007 Positron Emission Tomography/Magnetic Resonance Imaging in Prostate Cancer: A Single-Center Experience. [2022]

6. 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]

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

Initial Evaluation of [(18)F]DCFPyL for Prostate-Specific Membrane Antigen (PSMA)-Targeted PET Imaging of Prostate Cancer. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Image acquisition and interpretation of 18F-DCFPyL (piflufolastat F 18) PET/CT: How we do it. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Threshold for defining PSMA-positivity prior to 177Lu-PSMA therapy: a comparison of [68Ga]Ga-PSMA-11 and [18F]F-DCFPyL in metastatic prostate cancer. [2023]

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

Gallium 68 PSMA-11 PET/MR Imaging in Patients with Intermediate- or High-Risk Prostate Cancer. [2021]

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

[18F]-JK-PSMA-7 PET/CT Under Androgen Deprivation Therapy in Advanced Prostate Cancer. [2021]