MRI Scans for Prostate Cancer

Overseen By Tharakeswara K. Bathala, MBBS,MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

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

Compensation: Varies

Number of Visits: 1

98 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how well magnetic resonance whole body diffusion-weighted imaging works in finding cancer that has spread to the bone or lymph nodes (metastasis) in participants with high-risk prostate cancer. Diagnostic procedures, such as magnetic resonance whole body diffusion-weighted imaging (a method to show how water moves in a certain area) may help find bone or lymph nodes metastasis.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently receiving or have a history of taking testosterone suppressing medications or local radiation therapy.

What data supports the effectiveness of the treatment Magnetic Resonance Whole Body Diffusion-Weighted Imaging for prostate cancer?

Research shows that diffusion-weighted imaging (DWI) is useful for detecting and monitoring prostate cancer, as it helps in identifying tumors and assessing their response to treatments. This suggests that Magnetic Resonance Whole Body Diffusion-Weighted Imaging could be effective in evaluating prostate cancer. ^{1 2 3 4 5}

Is MRI scanning for prostate cancer safe for humans?

MRI scans, including diffusion-weighted imaging (DWI), are generally considered safe for humans as they are noninvasive and do not use ionizing radiation, which is harmful. These scans have been used in various studies for prostate cancer without specific safety concerns reported. ^{3 5 6 7 8}

How is Magnetic Resonance Whole Body Diffusion-Weighted Imaging different from other treatments for prostate cancer?

Magnetic Resonance Whole Body Diffusion-Weighted Imaging is unique because it uses MRI technology to create detailed images of the entire body without radiation, helping to detect and monitor prostate cancer spread more effectively than traditional imaging methods. This approach is particularly useful for assessing bone and soft tissue involvement, which can be challenging with other techniques. ^{3 9 10 11 12}

Research Team

Tharakeswara Bathala

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for individuals with high-risk prostate cancer, specifically those who have a PSA level over 20 ng/ml and/or a Gleason score of 8 or higher. Participants must be able to understand and sign consent. It's not for those on testosterone suppressing drugs, previous radiation therapy, low-risk patients (Gleason score < 8), or anyone who can't undergo MRI.

Inclusion Criteria

My PSA level is over 20 ng/ml or my Gleason score is 8 or higher, indicating high-risk prostate cancer.

Ability to understand and sign informed consent

Exclusion Criteria

I have been treated with hormone therapy or radiation for my condition.

My initial Gleason score for prostate cancer was below 8, indicating low risk of spreading.

Contraindication to magnetic resonance imaging (MRI)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Imaging

Participants undergo standard of care bone scan, CT of the abdomen and pelvis, and pelvic MRI. Participants also undergo magnetic resonance whole body diffusion-weighted imaging (WB-DWI) over 20-30 minutes.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after diagnostic imaging procedures

Up to 9 years

Treatment Details

Interventions

• Magnetic Resonance Whole Body Diffusion-Weighted Imaging

Trial Overview The study is testing the effectiveness of magnetic resonance whole body diffusion-weighted imaging in detecting the spread of prostate cancer to bones or lymph nodes compared to traditional bone scans and CT scans.

Participant Groups

Group I: Diagnostic (bone scan, CT, MRI, magnetic resonance WB-DWI) Experimental Treatment 4 Interventions

Participants undergo standard of care bone scan, CT of the abdomen and pelvis, and pelvic MRI. Participants also undergo magnetic resonance WB-DWI over 20-30 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

In a study of 43 patients at high risk for prostate cancer, diffusion-weighted imaging (DWI) at 3 Tesla successfully detected prostate cancer in 39.5% of cases, highlighting its efficacy in identifying lesions that were missed in previous biopsies.

DWI was particularly effective in locating tumors in the transitional zone of the prostate, with 76.4% of detected cancers found there, and it provided valuable information that was not always visible on traditional T2-weighted imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lesion localization in patients with a previous negative transrectal ultrasound biopsy and persistently elevated prostate specific antigen level using diffusion-weighted imaging at three Tesla before rebiopsy. Park, BK., Lee, HM., Kim, CK., et al.[2009]

Diffusion-weighted imaging (DWI) can effectively monitor changes in prostate cancer after 6 months of antiandrogen therapy, showing reduced hypointense signals in most patients, which indicates a response to treatment.

In some cases, DWI provided clearer visualization of residual tumors compared to traditional imaging methods, suggesting it may enhance the understanding of prostate cancer dynamics, especially in patients with low PSA recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in diffusion-weighted images for visualizing prostate cancer during antiandrogen therapy: preliminary results. Nemoto, K., Tateishi, T., Ishidate, T.[2016]

In a study of 51 patients, computed diffusion-weighted imaging (cDWI) in whole-body MRI (bpWB-MRI) showed diagnostic performance for detecting clinically significant prostate cancer (PCa) that is comparable to traditional pelvic MRI, with areas under the curve (AUCs) of 0.86 and 0.89 respectively.

The results suggest that cDWI can be effectively integrated into standard whole-body MRI protocols, allowing for simultaneous detection of both primary and metastatic prostate cancer, enhancing the efficiency of cancer evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic value of computed high b-value whole-body diffusion-weighted imaging for primary prostate cancer. Arita, Y., Yoshida, S., Waseda, Y., et al.[2021]

In a study of 88 prostate cancer patients, both acquired diffusion-weighted imaging (aDWI) and computed diffusion-weighted imaging (cDWI) showed similar sensitivity for tumor detection, with sensitivities of 94% and 90% respectively, indicating that both imaging techniques are effective for diagnosing prostate cancer.

The inter-observer agreement for tumor detection was moderate for both imaging methods, with kappa values of 0.495 for aDWI and 0.422 for cDWI, suggesting that both techniques provide reliable results that can be consistently interpreted by different reviewers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Computed Diffusion-Weighted Imaging b2000 and Acquired Diffusion-Weighted Imaging b2000 for Detection of Prostate Cancer. Kim, YJ., Kim, SH., Baek, TW., et al.[2023]

References

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

Lesion localization in patients with a previous negative transrectal ultrasound biopsy and persistently elevated prostate specific antigen level using diffusion-weighted imaging at three Tesla before rebiopsy. [2009]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Changes in diffusion-weighted images for visualizing prostate cancer during antiandrogen therapy: preliminary results. [2016]

3. Ireland pubmed.ncbi.nlm.nih.gov

Diagnostic value of computed high b-value whole-body diffusion-weighted imaging for primary prostate cancer. [2021]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Comparison of Computed Diffusion-Weighted Imaging b2000 and Acquired Diffusion-Weighted Imaging b2000 for Detection of Prostate Cancer. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Computed diffusion-weighted imaging of the prostate at 3 T: impact on image quality and tumour detection. [2022]

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

Diffusion-weighted magnetic resonance imaging in patients with prostate cancer treated with radiotherapy. [2017]

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

DWI-MRI: single, informative, and noninvasive technique for prostate cancer diagnosis. [2021]

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

Whole-body MRI including diffusion-weighted imaging (DWI) for patients with recurring prostate cancer: technical feasibility and assessment of lesion conspicuity in DWI. [2011]

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

Metastasis Reporting and Data System for Prostate Cancer in Practice. [2019]

10. Italy pubmed.ncbi.nlm.nih.gov

Unenhanced whole-body MRI versus PET-CT for the detection of prostate cancer metastases after primary treatment. [2022]

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

Clinical utility of diffusion-weighted magnetic resonance imaging in prostate cancer. [2022]

12. Australia pubmed.ncbi.nlm.nih.gov

Whole-body diffusion-weighted magnetic resonance imaging: Diagnosis and follow up of prostate cancer and beyond. [2021]