What side effects are associated with this type of intervention?

Common treatments for prostate adenocarcinoma, such as radiation therapy and androgen deprivation therapy (ADT), have several known side effects. Radiation therapy, including IGRT, hypofractionated RT, and proton-beam RT, can cause acute gastrointestinal toxicity, urinary symptoms, and, in some cases, late toxicity affecting bowel and bladder function. ADT often leads to side effects like hot flashes, decreased libido, fatigue, and potential cardiovascular issues. Advanced imaging techniques like PSMA PET/CT are generally well-tolerated but may involve exposure to radiation and the need for intravenous contrast agents, which can cause allergic reactions in some patients.

What prior FDA approvals exist?

The FDA has approved several treatments for Prostate Adenocarcinoma that utilize advanced imaging and targeted therapies. Lutetium Lu 177 vipivotide tetraxetan, approved for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC), is one such treatment that benefits from advanced imaging techniques like PSMA PET scans to identify suitable candidates. Additionally, androgen receptor signaling inhibitors such as enzalutamide and abiraterone have been approved for mCRPC, often used in conjunction with imaging studies to monitor treatment response and disease progression. These approvals highlight the integration of advanced imaging modalities in the management and treatment of prostate cancer.

What other types of research exist?

Promising novel alternatives to multi-modality imaging studies for prostate adenocarcinoma patients include: 1) PSMA PET/CT using radiotracers like Ga-68 PSMA-11 or piflufolastat F-18, which offer high sensitivity for detecting metastatic disease at lower PSA levels. 2) Whole-body MRI, which can be used for staging nodal and distant metastatic disease in high-risk patients. 3) Advanced molecular and biomarker analysis of tumor tissue, which can provide insights into tumor biology and guide personalized treatment decisions.

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Sodium MRI + PSMA PET for Prostate Cancer (IGPC-5 Trial)

Phase 2

Recruiting

Led By Joseph Chin, MD, FRCSC

Research Sponsored by Glenn Bauman

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include allergic reactions to contrast agents used during imaging procedures. There's also a risk of discomfort or complications from lying still during long scans and exposure to radiation from PET scans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pathologic Validation and Modeling

Trial Design

1Treatment groups

Experimental Treatment

Group I: Multi-modality prostate cancer imagingExperimental Treatment4 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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sodium MRI

2019

N/A

~10

Multiparametric MRI

2013

N/A

~110

PET Scan

2006

Completed Phase 3

~610

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Prostate Adenocarcinoma include hormonal therapy, chemotherapy, and immunotherapy. Hormonal therapy, such as androgen deprivation therapy (ADT), works by reducing levels of male hormones that can promote cancer growth. Chemotherapy, using drugs like docetaxel, targets rapidly dividing cancer cells to inhibit their growth and spread. Immunotherapy, including agents like pembrolizumab, enhances the body's immune response to target and destroy cancer cells. These treatments are crucial for patients as they can be tailored based on imaging biomarkers, which help in predicting the cancer's location and aggressiveness, thereby optimizing treatment efficacy and outcomes.

Recent Advances in Epigenetic Biomarkers and Epigenetic Targeting in Prostate Cancer.Assessing Prostate Cancer Aggressiveness with Hyperpolarized Dual-Agent 3D Dynamic Imaging of Metabolism and Perfusion.

Find a Location

Who is running the clinical trial?

University of Western Ontario, CanadaOTHER

164 Previous Clinical Trials

319,193 Total Patients Enrolled

Western University, CanadaOTHER

248 Previous Clinical Trials

53,331 Total Patients Enrolled

Centre for Probe Development and CommercializationOTHER

6 Previous Clinical Trials

3,268 Total Patients Enrolled

Media Library

Multiparametric MRI Clinical Trial Eligibility Overview. Trial Name: NCT04053842 — Phase 2

Prostate Adenocarcinoma Research Study Groups: Multi-modality prostate cancer imaging

Prostate Adenocarcinoma Clinical Trial 2023: Multiparametric MRI Highlights & Side Effects. Trial Name: NCT04053842 — Phase 2

Multiparametric MRI 2023 Treatment Timeline for Medical Study. Trial Name: NCT04053842 — Phase 2

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