Advanced MRI Techniques for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Low-risk prostate cancer, Other malignancy, Cardiac pacemaker, others

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

Compensation: Varies

Number of Visits: 1

33 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial studies examines a 3D magnetic resonance imaging (MRI) compared to standard MRI imaging techniques in screening patients with prostate cancer. Diagnostic procedures, such as MRI, may help find and diagnose prostate cancer. Computer systems that allow doctors to create a 3-dimensional (3-D) picture of the tumor may help in planning.

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

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

What data supports the effectiveness of the treatment Novel Synthetic T2W MR Imaging and Spin Parameter Mapping Techniques for prostate cancer?

Research shows that advanced MRI techniques, like multiparametric MRI, can effectively identify and assess prostate cancer, helping to detect aggressive forms of the disease. These techniques improve the quality of imaging, which is crucial for accurate diagnosis and treatment planning. ^{1 2 3 4 5}

How is the treatment Novel Synthetic T2W MR Imaging and Spin Parameter Mapping Techniques different from other prostate cancer treatments?

This treatment is unique because it uses advanced MRI techniques to improve the detection and localization of prostate cancer, potentially offering higher resolution and better image quality compared to standard MRI methods. It focuses on novel imaging sequences and mapping techniques that may provide more detailed information about prostate tissue composition and cancer presence. ^{3 6 7 8 9}

Research Team

Tharakeswara Bathala

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for men aged 18 or older with intermediate to high-risk prostate cancer that hasn't been treated yet. They must be considering a radical prostatectomy (surgery to remove the prostate) and able to undergo scanning with a 3T magnet MRI. Exclusions include having a pacemaker, metal in the pelvis/spine, active cancers within 2 years, claustrophobia, low-risk cancer types or specific cellular features.

Inclusion Criteria

You are being considered for a surgery called radical prostatectomy to treat your prostate cancer with the goal of curing it.

Patient has provided written informed consent for participation in this trial

Male, age >= 18

Exclusion Criteria

You have a pacemaker for your heart.

You have metal implants in your spine or pelvis.

You had another type of cancer within the past two years that is still active.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo 3D MRI imaging over 15 minutes with standard of care MRI or at a separate time

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

1 year

Treatment Details

Interventions

• Novel Synthetic T2W MR Imaging and Spin Parameter Mapping Techniques

Trial Overview The study is testing how well a new type of 3D MRI technique works compared to standard MRI methods in screening patients with prostate cancer. The goal is to see if this new imaging can create better three-dimensional pictures of tumors which may improve diagnosis and treatment planning.

Participant Groups

Group I: Screening (3D MRI) Experimental Treatment 1 Intervention

Patients undergo 3D MRI imaging over 15 minutes with standard of care MRI or at a separate time.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

1. The study found that 1.5T mpMRI can effectively identify high-grade prostate cancers, with a positive predictive value of 45% and a negative predictive value of 82%, indicating its utility in guiding prostate biopsies.

2. In patients with a normal mpMRI, 81.8% were negative for clinically significant cancer at biopsy, suggesting that targeted biopsies alone may miss significant cancers in about 50% of cases, highlighting the importance of combining mpMRI with saturation biopsies for accurate diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does 1.5 T mpMRI play a definite role in detection of clinically significant prostate cancer? Findings from a prospective study comparing blind 24-core saturation and targeted biopsies with a novel data remodeling model. Dal Moro, F., Zecchini, G., Morlacco, A., et al.[2019]

The 1H MR spectroscopic imaging sequence (1H-2D-CSI) successfully distinguished prostate cancer from benign prostate hyperplasia using the citrate/(choline + creatine) ratio in a study of 18 patients.

However, the method could not differentiate between high-grade prostatic intraepithelial neoplasia and prostate cancer, indicating that higher spatial resolution may be needed for better tumor differentiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Spectroscopic imaging (1H-2D-CSI) of the prostate: sequence optimization and correlation with histopathological results]. Stanka, M., Eltze, E., Semjonow, A., et al.[2013]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

MRI-Derived Restriction Spectrum Imaging Cellularity Index is Associated with High Grade Prostate Cancer on Radical Prostatectomy Specimens. [2020]

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

Multiparametric MRI identifies and stratifies prostate cancer lesions: implications for targeting intraprostatic targets. [2018]

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

MR imaging of the prostate: 1.5T versus 3T. [2015]

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

Does 1.5 T mpMRI play a definite role in detection of clinically significant prostate cancer? Findings from a prospective study comparing blind 24-core saturation and targeted biopsies with a novel data remodeling model. [2019]

5. Ireland pubmed.ncbi.nlm.nih.gov

Evaluation of semi-quantitative dynamic contrast-enhanced MRI parameters for prostate cancer in correlation to whole-mount histopathology. [2022]

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

Prostate tissue composition and MR measurements: investigating the relationships between ADC, T2, K(trans), v(e), and corresponding histologic features. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

T1 mapping of the prostate using Single-Shot T1FLASH and MOLLI MRI Techniques: Comparison of artifact burden and image quality. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Prostate cancer discrimination in the peripheral zone with a reduced field-of-view T(2)-mapping MRI sequence. [2018]

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

[Spectroscopic imaging (1H-2D-CSI) of the prostate: sequence optimization and correlation with histopathological results]. [2013]