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

Must not be taking: 5-alpha reductase inhibitors

Disqualifiers: Prior prostate therapy, Kidney 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: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve prostate cancer diagnosis before surgery. It will use a combination of imaging techniques, including advanced MRI and PET scans, to determine which best predicts the cancer's location and aggressiveness. The imaging methods being tested include Sodium MRI and [18F]PSMA-1007 Injection. Men with confirmed prostate cancer who plan to undergo surgery as part of their regular care might be suitable for this study. The goal is to gather information that can help doctors make more accurate treatment plans in the future. As a Phase 2 trial, this research focuses on evaluating the effectiveness of the imaging methods in an initial, smaller group of participants, offering them a chance to contribute to advancements in prostate cancer diagnosis.

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 prior data suggests that these imaging techniques are safe for prostate cancer patients?

Research has shown that the imaging techniques used in this trial, including special injections for PET scans, have been well-studied. Studies indicate that one of these injections, [18F]DCFPyL, is safe and spreads in the body as expected, gathering in areas where cancer might be. Another injection, [18F]PSMA-1007, has also shown promise in detecting prostate cancer and has a good safety record in past studies.

Research confirms that multiparametric MRI, which combines different imaging methods, is helpful in diagnosing prostate cancer. It is a common and safe tool that assists doctors in assessing cancer risk and planning treatments.

Sodium MRI is a newer technique that shows potential in detecting prostate cancer by measuring sodium levels in tissues. Although still under study, early research suggests it can safely provide useful information.

Overall, these imaging methods have been shown to be well-tolerated. For those considering joining a trial, previous research suggests that these imaging methods are generally safe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores a novel approach to imaging prostate cancer by combining sodium MRI, multiparametric MRI (mpMRI), and PSMA PET scanning. Unlike standard imaging methods, which typically rely on either MRI or CT scans to visualize tumors, this trial integrates sodium MRI, providing unique insights into the tumor's metabolic environment. Additionally, the use of PSMA PET with radio-labeled probes like [18F]PSMA-1007 and [F-18]-DCFPyL targets prostate-specific membrane antigens, potentially enhancing the accuracy of cancer detection. This multi-modality imaging could lead to more precise diagnostics and better treatment planning for prostate cancer patients.

What evidence suggests that this trial's imaging techniques could be effective for prostate cancer?

Research has shown that both Sodium MRI and Multiparametric MRI are promising methods for detecting prostate cancer. Previous studies found that the amount of sodium in tissue, measured by Sodium MRI, increases with cancer severity, suggesting it can help identify more aggressive tumors. Multiparametric MRI accurately locates prostate cancer, providing detailed images of the prostate.

In this trial, participants will undergo multi-modality prostate cancer imaging, including Sodium MRI, Multiparametric MRI, and PSMA PET imaging. Studies have shown that [18F]PSMA-1007 is particularly effective at detecting cancer even when PSA levels, a protein linked to prostate cancer, are low, with an 84% detection rate in these low PSA cases. Similarly, [18F]DCFPyL demonstrated a high detection rate of 92% in prostate cancer cases overall, making these PET tracers effective tools for identifying cancerous cells. ^{6 7 8 9 10}

Who Is on the Research Team?

Stephen Pautler, MD, FRCSC

Principal Investigator

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

Are You a Good Fit for This Trial?

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)

Contraindication to MRI: pacemaker or other electronic implants, known metal in the orbit, cerebral aneurysm clips

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/251575

Comparison of [¹⁸F]PSMA-1007, [¹⁸F]DCFPyL, and [⁶⁸Ga ... [¹⁸F]PSMA-1007 demonstrated superior lesion detection at low PSA levels (<0.5 ng/mL), achieving a DR of 84% compared to 68% for [⁶⁸Ga]Ga-PSMA-11 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29269569/

Intraindividual Comparison of 18 F-PSMA-1007 and 18 ... This clinical study presents an intraindividual comparison to evaluate tracer-specific characteristics of 18 F-DCFPyL versus 18 F-PSMA-1007.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0969805121005345

Recent advancements in 18F-labeled PSMA targeting PET ... The clinically established 18F-PSMA PET tracers [18F]DCFPyL and [18F]PSMA-1007 have already demonstrated promising results for the detection of prostate cancer ...

4. link.springer.com link.springer.com/article/10.1007/s11307-015-0850-8

Initial Evaluation of [18F]DCFPyL for Prostate-Specific ... [18F]DCFPyL demonstrated favorable dosimetry with significantly lower doses to most radiosensitive organs in comparison to our first-generation ...

5. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2020.597422/full

Evaluation of 18F-DCFPyL PSMA PET/CT for Prostate ... The pooled detection rate (DR) of 18F-DCFPyL PSMA PET/CT in Pca was 92%. The pooled DR was 89% for PSA ≥0.5 ng/ml and 49% for PSA <0.5 ng/ml.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6309696/

Multiparametric MRI and prostate cancer diagnosis and risk ... We will review multiparametric MRI (MP-MRI) for localized prostate cancer, emphasizing its potential role in risk stratification and improving outcomes.

7. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2827887

Oncological Safety of MRI-Informed Biopsy Decision ... Findings In this cohort study involving 593 biopsy-naive men, 48% had negative MRI results, 86% of whom avoided biopsy over 3 years. After 3 ...

8. auanet.org auanet.org/guidelines-and-quality/guidelines/other-clinical-guidance/mri-of-the-prostate-sop

Prostate Cancer Multi-parametric MRI (mpMRI) has been proven to be a valuable tool in the diagnostic and management pathway in men at risk of prostate cancer.

9. nature.com nature.com/articles/s41598-024-65354-0

Prostate cancer diagnosis based on multi-parametric MRI ... In this study, mpMRI images were used to classify patients. In the proposed method, a quadruple sequence of mpMRI images is analyzed and then ...

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S107814392400485X

mpMRI in prostate cancer screening and diagnosis This contemporary review evaluates the most recent literature on the role of mpMRI in the screening and diagnosis of prostate cancer.