Dixon MRI for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase < 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Hormone ablation, Radiation therapy, Metal implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

65 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies the use of magnetic resonance imaging (MRI) with Dixon based imaging sequences in detecting prostate cancer. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. Researchers hope to learn if using a modified MRI scan technique with Dixon based imaging sequencing will help to produce better images of prostate cancer than the standard of care MRI scan technique.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Dixon MRI for prostate cancer?

Research shows that MRI is a valuable tool in diagnosing prostate cancer, especially in patients with previous negative biopsies and high PSA levels. It helps in accurately targeting cancer, which can improve decision-making for further treatment. ^{1 2 3 4 5}

Is Dixon MRI safe for humans?

The research articles reviewed do not provide specific safety data for Dixon MRI, but they discuss the use of MRI in prostate cancer management, which is generally considered safe for humans. ^{4 6 7 8 9}

How is Dixon MRI treatment different from other prostate cancer treatments?

Dixon MRI is a unique imaging technique used for prostate cancer diagnosis and management, offering high-resolution images that help in detecting and localizing cancer, as well as evaluating its spread beyond the prostate. Unlike traditional treatments, it is non-invasive and enhances the accuracy of cancer detection, potentially reducing the need for multiple biopsies. ^{2 10 11 12 13}

Research Team

Ganeshan Dhakshina Moorthy

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for men with biopsy-proven prostate cancer who have consented to participate, are scheduled for prostate removal surgery (prostatectomy), and a standard MRI scan. It's not open to those who've had hormone or radiation therapy affecting the pelvis or prostate, prefer other treatments over surgery, or can't have MRIs due to metal implants or pacemakers.

Inclusion Criteria

I have prostate cancer confirmed by biopsy and will have surgery to remove my prostate.

I am scheduled for a prostate MRI to check the cancer stage.

Patients who have signed their informed consent form to undergo the study

Exclusion Criteria

Contraindication to conventional MR imaging (e.g. metal implants, pacemaker, etc.)

I have had hormone therapy or radiation for my pelvic or prostate area.

I prefer not to have surgery for my prostate condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Imaging

Patients undergo MRI with additional Dixon based sequences with fat and water over a total of 49 minutes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

• Dixon MRI

Trial Overview The study is testing whether a modified MRI technique using Dixon based imaging sequences can provide better images of prostate cancer compared to the usual MRI scans. The goal is to see if this new scanning method improves the detection and visualization of prostate tumors.

Participant Groups

Group I: Diagnostic (standard MRI, Dixon MRI) Experimental Treatment 2 Interventions

Patients undergo MRI with additional Dixon based sequences with fat and water over a total of 49 minutes.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Magnetic resonance imaging (MRI) has a significant diagnostic performance for detecting prostate cancer in patients with prior negative biopsies and elevated PSA levels, with a mean detection rate of 37.5% across 14 studies involving 698 patients.

MRI combined with magnetic resonance spectroscopy imaging (MRSI) shows the highest accuracy, achieving a pooled sensitivity of 91% and specificity of 73%, indicating it is a valuable tool for targeting prostate cancer in challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of magnetic resonance imaging in the detection of prostate cancer in patients with previous negative biopsies and elevated prostate-specific antigen levels: a meta-analysis. Zhang, ZX., Yang, J., Zhang, CZ., et al.[2022]

MRI is becoming increasingly important for diagnosing and monitoring prostate cancer, with ongoing research aimed at identifying specific imaging characteristics that enhance its effectiveness.

The article discusses the Prostate Imaging Reporting and Data System (PI-RADS), a standardized scoring and reporting system that helps radiologists evaluate prostate MRI results, particularly for patients with varying biopsy histories and PSA levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging for prostate cancer: what the urologist needs to know. Kiechle, J., Pahwa, S., Gulani, V., et al.[2017]

In a study of 122 men with Gleason 6 prostate cancer, transrectal prostate biopsy was found to have a significantly greater temporary negative impact on quality of life compared to prostate multiparametric MRI (mpMRI), with quality of life scores of 0.82 versus 0.95, respectively.

The most notable difference in health impact was related to intraprocedural pain, where biopsy patients reported much higher pain levels than those undergoing mpMRI, indicating that mpMRI may be a safer and less painful option for monitoring prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporary Health Impact of Prostate MRI and Transrectal Prostate Biopsy in Active Surveillance Prostate Cancer Patients. Shankar, PR., Maturen, KE., George, AK., et al.[2020]

Magnetic resonance imaging (MRI) is becoming increasingly important for diagnosing prostate cancer due to its high resolution, which allows for effective detection, localization, and evaluation of cancer spread beyond the prostate.

MRI is recommended by clinical guidelines for patients with at least one negative biopsy, and it is particularly useful for staging advanced tumors (cT3/4) or those with a high Gleason score (≥8), enhancing the accuracy of targeted biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prostate cancer]. Franiel, T., Eckardt, N., Waginger, M., et al.[2022]

References

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

The value of magnetic resonance imaging in the detection of prostate cancer in patients with previous negative biopsies and elevated prostate-specific antigen levels: a meta-analysis. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

Survey on prostate MRI reading and interpretation among urology residents in Italy, Brazil and the UK: a cry for help. [2023]

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

Prostate cancer-specific mortality after radical prostatectomy: value of preoperative MRI. [2017]

4. Italy pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging for prostate cancer: what the urologist needs to know. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging for the diagnosis of prostate cancer metastatic to bone. [2019]

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

The utility of prostate MRI within active surveillance: description of the evidence. [2022]

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

Temporary Health Impact of Prostate MRI and Transrectal Prostate Biopsy in Active Surveillance Prostate Cancer Patients. [2020]

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

Magnetic resonance imaging in prostate brachytherapy: Evidence, clinical end points to data, and direction forward. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Multiparametric magnetic resonance imaging findings in men with low-risk prostate cancer followed using active surveillance. [2022]

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

[Prostate cancer]. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Nuclear magnetic resonance (NMR) imaging of the prostate. [2019]

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

MRI of the prostate: clinical relevance and emerging applications. [2015]

13. Germany pubmed.ncbi.nlm.nih.gov

[Imaging modalities for primary diagnosis and staging of prostate cancer]. [2021]