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

Must not be taking: Testosterone suppressants

Disqualifiers: Low metastasis risk, MRI contraindication, 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 explores a special type of MRI scan, called Magnetic Resonance Whole Body Diffusion-Weighted Imaging, to assess its effectiveness in detecting prostate cancer that has spread to bones or lymph nodes. The aim is to determine if this imaging method can more effectively identify areas of cancer spread. It is suitable for individuals with high-risk prostate cancer, particularly those with a PSA level over 20 or a Gleason score of 8 or higher, which indicates aggressive cancer. Participants will undergo several scans, including the experimental MRI, to collect comprehensive data. This trial is not suitable for individuals who have already received certain cancer treatments or have low-risk prostate cancer. As an unphased trial, it offers a unique opportunity to contribute to innovative imaging research that could enhance future cancer detection.

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 prior data suggests that magnetic resonance whole body diffusion-weighted imaging is safe for detecting metastasis in prostate cancer?

Research has shown that Magnetic Resonance Whole Body Diffusion-Weighted Imaging (MRI WB-DWI) safely checks for cancer spread. Studies recommend this MRI as the first choice for examining prostate cancer because it avoids radiation, making it safer than X-rays or CT scans.

MRI WB-DWI has successfully monitored men with advanced prostate cancer. It captures clear images quickly, usually in under 40 minutes. With no harmful radiation, it involves fewer risks.

Overall, patients tolerate MRI WB-DWI well, and studies have not reported major side effects. This makes it a reliable option for those considering clinical trials for prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Magnetic Resonance Whole Body Diffusion-Weighted Imaging (WB-DWI) for prostate cancer because it offers a non-invasive way to detect cancer spread throughout the body. Unlike traditional methods like bone scans and CT scans, which can expose patients to radiation, WB-DWI uses magnetic resonance imaging to map out cancerous tissue, offering a safer alternative. This technique also provides detailed images that can help in identifying cancer earlier and more accurately, potentially leading to better treatment outcomes.

What evidence suggests that magnetic resonance whole body diffusion-weighted imaging is effective for detecting metastasis in high-risk prostate cancer?

Research has shown that Magnetic Resonance Whole Body Diffusion-Weighted Imaging (WB-DWI), which participants in this trial will undergo, effectively detects cancer spread to bones or lymph nodes in high-risk prostate cancer patients. Studies have found that WB-DWI matches advanced PET/CT scans in detecting bone cancer and provides better details of soft tissues. One study found that WB-DWI has a high accuracy rate of 96% for identifying cancer spread, compared to traditional CT scans. This imaging method helps identify cancer spread with fewer unnecessary findings, providing clearer results. Overall, it offers significant advantages over other imaging methods for pinpointing cancer spread. ^{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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8978253/

Whole-body magnetic resonance imaging (WB-MRI) with ... In a previous study of WB-MRI with DWIBS in patients with prostate cancer, incidental findings were found in only 31% (31/100) of them. This lower detection ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/iju.14497

Whole‐body diffusion‐weighted magnetic resonance ... WB-DWI appears to be as effective as 11C-choline PET/CT for detection of bone metastases in patients with prostate cancer and shows a higher ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04117594

Whole Body Magnetic Resonance Imaging Study For this study the Whole body MRI (WB-MRI) includes a measurement called diffusion-weighted imaging (DWI) which is relatively new and has a high sensitivity for ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5966219/

UK quantitative WB-DWI technical workgroup Whole body MRI, including diffusion-weighted imaging (DWI), offers significant advantages over other cancer imaging modalities; combining a high soft tissue ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1076633218300953

Multiparametric Whole-body MRI with Diffusion-weighted ... Multiparametric WB-MRI had excellent sensitivity (96%) for detection of metastatic lesions compared to CT. ADC map values and the ADC ratio in metastatic bone ...

6. mdpi.com mdpi.com/2072-6694/17/2/275

The Whole-Body MRI Reporting and Data System ... MET-RADS-P was developed to stage and monitor men with advanced prostate cancer using WB-MRI. It has emerged as a reliable imaging biomarker for predicting ...

7. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/ryai.2021200279

Accelerating Whole-Body Diffusion-weighted MRI with ... A developed model, called quickDWI, enabled accelerated acquisition protocols for whole-body diffusion-weighted MRI of metastatic prostate, breast, and myeloma ...

8. ecancer.org ecancer.org/en/journal/article/1164-whole-body-magnetic-resonance-imaging-technique-guidelines-and-key-applications

Whole-body magnetic resonance imaging: technique ... WB-MRI is an imaging method without ionising radiation that can provide WB coverage with a core protocol of essential imaging contrasts in less than 40 minutes.

9. ajronline.org ajronline.org/doi/10.2214/AJR.11.7866

Whole-Body Diffusion-Weighted MRI: Tips, Tricks, and ... We examine the clinical impetus for whole-body diffusion-weighted MRI and discuss how to implement the technique with clinical MRI systems.