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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of using MRI scans to better visualize prostate cancer. The goal is to determine if 3D MRI images can provide doctors with a clearer view of the tumor, aiding in treatment planning. It targets men diagnosed with medium to high-risk prostate cancer who are considering prostate removal surgery. Participants should not have received any prior treatment for prostate cancer and must be comfortable spending about 15 minutes in an MRI scanner. As an unphased trial, this study allows participants to contribute to innovative imaging techniques that could enhance future prostate cancer treatment 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 prior data suggests that these advanced MRI techniques are safe for prostate cancer screening?

Research has shown that the 3D MRI techniques used in this study are generally safe for people. MRI scans, including the new imaging methods used here, do not involve radiation, making them a low-risk option for capturing images of the body.

Studies have found that these advanced MRI methods can effectively detect prostate cancer without causing harm. Some individuals might feel uncomfortable in the machine or experience mild anxiety, but no serious side effects have been reported.

Overall, these advanced MRI techniques are well-tolerated. Prospective participants can feel confident that the imaging procedure is considered safe based on current research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores advanced MRI techniques that could revolutionize prostate cancer diagnosis. Unlike traditional MRI methods, which can sometimes miss small or aggressive tumors, the novel synthetic T2W MR Imaging and Spin Parameter Mapping Techniques offer enhanced imaging clarity and detail. This could lead to more accurate detection and characterization of prostate cancer, potentially catching issues earlier and guiding more effective treatment plans. By providing a clearer picture, these advanced imaging techniques could significantly improve patient outcomes.

What evidence suggests that these advanced MRI techniques are effective for prostate cancer?

Research has shown that a new 3D MRI technique, which participants in this trial will undergo, could improve prostate cancer screening. Studies indicate that using C-SENSE AI technology speeds up imaging by 58% while providing clearer images and better tumor detection. This advancement allows doctors to identify cancerous areas more easily and quickly. One study found that this imaging technique performs as well as or better than current methods in detecting cancer in over 3,000 patients. This new approach offers the potential for more accurate and faster prostate cancer diagnosis. ^{1 6 7 8 9}

Who Is on the Research Team?

Tharakeswara Bathala

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05055843

Novel Synthetic T2W MR Imaging and Spin Parameter ... This clinical trial studies examines a 3D magnetic resonance imaging (MRI) compared to standard MRI imaging techniques in screening patients with prostate ...

2. analyticalsciencejournals.onlinelibrary.wiley.com analyticalsciencejournals.onlinelibrary.wiley.com/doi/10.1002/nbm.5069

Uncovering prostate cancer aggressiveness signal in T2 ... We will apply the normalization technique in longitudinal T2W datasets obtained before and following radiotherapy to characterize the quantitative changes in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9738899/

Prospectively Accelerated T2-Weighted Imaging of the ... C-SENSE AI enabled a 58% acceleration in T2w imaging of the prostate while obtaining significantly better image quality and tumor detection.

4. nature.com nature.com/articles/s41598-022-06872-7

Synthetic correlated diffusion imaging hyperintensity ... T2-weighted MRI (T2w) has been well-studied for PCa screening and diagnosis, where potentially cancerous regions are characterized by signal ...

5. arxiv.org arxiv.org/html/2411.07416v1

T2-only prostate cancer prediction by meta-learning from bi ... Using multiple datasets from more than 3,000 prostate cancer patients, we report superior or comparable performance in localising radiologist- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11612117/

Value of MRI - T2 Mapping to Differentiate Clinically ... Multiparametric MRI (mpMRI) is the preferred imaging modality for prostate cancer and includes T1-weighted, T2-weighted (T2w), diffusion ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6364699/

Novel Imaging of Prostate Cancer with MRI, MRI/US, and PET We review novel imaging techniques to image local and metastatic diseases. The discussion regarding the detection of local disease centers on the use of ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0302283824000678

The Transatlantic Recommendations for Prostate Gland ... All 20 studies (100%) reporting suspicious imaging features cited focal contrast enhancement as suspicious for cancer recurrence. Of 31 studies reporting MRI ...

9. ajronline.org ajronline.org/doi/10.2214/AJR.07.2211

Combined T2-Weighted and Diffusion-Weighted MRI for ... The objective of our study was to compare T2-weighted MRI alone and T2 combined with diffusion-weighted imaging (DWI) for the localization of prostate cancer.