What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as androgen deprivation therapy (ADT), radiotherapy, and chemotherapy, have various side effects. ADT can lead to hot flashes, decreased libido, fatigue, and osteoporosis. Radiotherapy may cause urinary symptoms, bowel issues, and erectile dysfunction. Chemotherapy often results in fatigue, nausea, hair loss, and increased risk of infections. The use of biparametric MRI (bpMRI) for prostate cancer detection, which avoids contrast enhancement, reduces the risk of side effects associated with gadolinium-based contrast agents, such as nephrogenic systemic fibrosis and allergic reactions.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including androgen deprivation therapies (ADT) like degarelix, androgen receptor inhibitors such as enzalutamide and abiraterone, and radioligand therapies like lutetium Lu 177 vipivotide tetraxetan. These treatments target different aspects of prostate cancer progression, from hormone manipulation to direct targeting of cancer cells. While the context does not provide specific FDA approvals related to biparametric MRI (bpMRI), this imaging technique is used to enhance prostate cancer detection and management by combining T2-weighted images and diffusion-weighted imaging (DWI) without the need for contrast enhancement.

What other types of research exist?

Promising novel alternatives to Biparametric MRI (bpMRI) for prostate cancer detection include: 1) PSMA PET/CT, which offers high sensitivity for detecting prostate cancer at lower PSA levels; 2) Advanced radiomics models that integrate MRI data with machine learning to improve diagnostic accuracy; 3) Tissue-based genomic assays like Oncotype DX Genomic Prostate Score, Prolaris, and Decipher, which provide additional risk stratification and can guide treatment decisions.

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MRI Technique

Abbreviated Biparametric MRI for Prostate Cancer

Phase 2

Waitlist Available

Led By Aradhana Venkatesan

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Secondary Objective Cohort: Treatment naïve patients with histologically confirmed intermediate risk prostate cancer (defined as Gleason score > 3+4 and a maximum cancer core length of > 4mm) with a clinical indication for prostate mpMRI, who are to undergo target selection for fusion guided biopsy

Primary Objective Cohort: Treatment naïve patients with histologically confirmed clinically significant prostate cancer (defined as Gleason score > 3+4 and a maximum cancer core length of > 4mm) with a clinical indication for prostate mpMRI for pre-treatment tumor detection and staging

Must not have

Patients who have already received androgen deprivation therapy or undergone prior surgery, radiotherapy or focal ablative therapies to the prostate

Patients less than 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new MRI scan method for men with newly diagnosed prostate cancer. The scan combines detailed imaging and water movement analysis to detect cancer. The goal is to see if this method is as effective as the standard MRI but simpler and cheaper.

Who is the study for?

This trial is for treatment-naive patients with clinically significant prostate cancer (Gleason score > 3+4, cancer core length > 4mm) needing an MRI before treatment or biopsy. Excluded are those with pacemakers, conditions preventing MR imaging at 3T, under age 18, unable to use an endorectal coil, prior androgen therapy or prostate treatments, over 400 pounds weight, unable to consent or recent biopsy.

What is being tested?

The study tests a simplified MRI method called biparametric MRI (RSI + T2WI), which could be faster and cheaper than the standard multiparametric MRI by omitting certain sequences like DCE imaging. It aims to see if this simpler method can still effectively detect and stage prostate cancer.

What are the potential side effects?

Since the intervention involves only non-contrast biparametric MRI scanning without gadolinium-based contrast agents used in typical mpMRI scans, there are minimal side effects expected other than those associated with standard MRIs such as discomfort from lying still.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have intermediate risk prostate cancer and have not received any treatment yet.

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I have significant prostate cancer (Gleason score > 3+4) and need an mpMRI for staging.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had treatments like hormone therapy or surgery for prostate cancer.

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I am under 18 years old.

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I am unable to understand and give consent for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: MRI techniqueExperimental Treatment1 Intervention

restriction spectrum imaging (RSI) can detect prostate cancer better than a standard-of-care MRI.

0 / 5Eligibility criteria met

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 cancer include androgen deprivation therapy (ADT), radiation therapy, and focal therapies. ADT works by lowering testosterone levels, which prostate cancer cells rely on for growth. Radiation therapy uses high-energy rays to kill cancer cells or inhibit their growth. Focal therapies, such as high-intensity focused ultrasound (HIFU) and cryotherapy, target and destroy cancerous tissues while sparing surrounding healthy tissue. Understanding these mechanisms is crucial for patients as it helps them comprehend how each treatment targets cancer cells, the potential side effects, and the rationale behind using advanced imaging techniques like bpMRI to guide and monitor treatment efficacy without the need for contrast agents.

Prostate Cancer Brain Metastasis: Review of a Rare Complication with Limited Treatment Options and Poor Prognosis.Resistance to prostate cancer treatments.Focal therapy for localized prostate cancer in the era of routine multi-parametric MRI.