mpMRI Monitoring for Prostate Cancer

Overseen By Karen Holcomb

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: National Cancer Institute (NCI)

Disqualifiers: Metastatic cancer, Radiation, Bleeding disorder, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

508 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: Active surveillance (AS) is a standard approach to treat low and intermediate risk prostate cancer. For AS, disease progression is monitored. AS uses biopsies, prostate specific antigen (PSA) blood tests, and other tools. Researchers want to see if multiparametric magnetic resonance imaging (mpMRI) can help improve AS. Objective: To see if mpMRI can improve how people are monitored during AS. Eligibility: Men age 18 and older who have been diagnosed with prostate cancer within the last 2 years. Design: Participants will undergo AS. Their PSA level will be checked once a year via blood test. They will have a digital rectal exam once a year. Participants will have biopsies every 2-3 years. Needles will be put into different parts of the prostate. The needles are guided by ultrasound imaging. Participants will also have targeted biopsies with mpMRI and MRI guided fusion (MRI-US fusion). MRI-US fusion combines previous MRI images with live ultrasound images. For MRIs, participants will lie on their stomach on the scanner table. A coil may be placed in the rectum. Participants will have a physical exam and medical record review at least every 3 years. Their weight and vital signs will be checked. They will give data about their daily activities, side effects, and symptoms. Every 2-3 years, participants will fill out surveys about their prostate health and quality of life. Participants may give blood, urine, prostate secretion, and saliva samples. The samples will be used for research. Participation will last for as long as the participant does not need actual treatment for his prostate cancer....

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. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment mpMRI for prostate cancer?

Research shows that mpMRI can accurately detect high-grade and larger prostate cancers, making it a useful tool for identifying significant cases. It is also effective in assessing the local extent of prostate cancer and predicting the pathology and staging of tumors. ^{1 2 3 4 5}

Is mpMRI safe for humans?

The research does not provide specific safety data for mpMRI, but it is commonly used in monitoring prostate cancer and is generally considered safe for humans. ^{1 5 6 7 8}

How does mpMRI monitoring differ from other treatments for prostate cancer?

mpMRI (multiparametric magnetic resonance imaging) is unique because it is a non-invasive imaging technique that helps accurately locate prostate cancer, assess its risk, and guide treatment decisions without the need for invasive procedures like biopsies. Unlike traditional methods, mpMRI combines detailed anatomical images with functional imaging techniques, improving the detection and staging of clinically significant prostate cancers. ^{9 10 11 12 13}

Research Team

Peter A Pinto, M.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

Men over 18 with prostate cancer diagnosed within the last two years, who have chosen active surveillance and meet specific health criteria. They must not have advanced disease, prior pelvic radiation or surgeries that affect imaging or biopsy accuracy, severe bleeding disorders, extreme immunocompromise, contraindications to mpMRI including allergies to contrast agents or poor kidney function.

Inclusion Criteria

Subjects must be co-enrolled to NCI protocol 16-C-0010 Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue

I am a man and I am 18 years old or older.

My prostate cancer has a Gleason score of 7 or less, with a primary pattern of 3.

Exclusion Criteria

I have had treatment directly on my prostate for cancer.

My prostate cancer has spread beyond the prostate.

I have had radiation treatment to my pelvic area.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Active Surveillance

Participants undergo active surveillance with PSA checks, digital rectal exams, and biopsies. mpMRI is used to monitor disease progression.

Ongoing

Annual PSA and DRE, biopsies every 2-3 years

Follow-up

Participants are monitored for safety and effectiveness after active surveillance interventions

4 weeks

Treatment Details

Interventions

• mpMRI

Trial Overview The trial is testing if multiparametric magnetic resonance imaging (mpMRI) can better monitor disease progression in men undergoing active surveillance for low and intermediate risk prostate cancer. It involves regular PSA tests, biopsies guided by ultrasound and mpMRI technology, physical exams and questionnaires about quality of life.

Participant Groups

Group I: AS + mpMRI Experimental Treatment 1 Intervention

Active surveillance (AS) with the following: a) Initial PSA and DRE screen; then, PSA screening every 12 months, with DRE every year mpMRI or prostate biopsy is performed; b) Initial mpMRI and then prior to all biopsies; c) Initial systemic prostate biopsy and MRI/US fusion-guided prostate biopsy of all suspicious lesions; then, every 2 years for 5 years and then every 3 years

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

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]

Multi-parametric MRI (mpMRI) is an effective tool for detecting and staging early prostate cancer, with a high negative predictive value of 95% for significant cancer when results are normal, making it a reliable option before biopsy.

mpMRI enhances treatment planning by guiding targeted therapies and surgical options, and its high spatial resolution allows for detailed assessment of disease spread, including extra-capsular extension and involvement of nearby structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of multi-parametric MRI in loco-regional staging of men diagnosed with early prostate cancer. Appayya, MB., Johnston, EW., Punwani, S.[2015]

Multiparametric magnetic resonance imaging (mpMRI) demonstrated a high predictive value for significant prostate cancer detection, with a positive predictive value (PPV) of 95% and a sensitivity of 91% for cases with a PI-RADS score of 3 or higher, based on an analysis of 235 patients who underwent radical prostatectomy.

The accuracy of mpMRI improved significantly with the adoption of PI-RADS version 2, showing higher sensitivity for predicting significant prostate cancer and T3 disease, indicating that updated technical specifications and reporting criteria enhance diagnostic performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the accuracy of multiparametric MRI for predicting prostate cancer pathology and tumour staging in the real world: an multicentre study. Kam, J., Yuminaga, Y., Krelle, M., et al.[2020]

The automated analysis tool for assessing prostate cancer using multiparametric MRI demonstrated a high sensitivity of 85.7% and specificity of 87.5% in a study involving 45 patients, indicating its effectiveness in detecting prostate cancer.

The tool's diagnostic accuracy of 86.7% is comparable to that of human readers using the PI-RADS system, suggesting it could be a valuable support system for less experienced radiologists in diagnosing and assessing prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an Automated Analysis Tool for Prostate Cancer Prediction Using Multiparametric Magnetic Resonance Imaging. Roethke, MC., Kuru, TH., Mueller-Wolf, MB., et al.[2022]

In a pilot study involving 8 patients with localized prostate cancer, multiparametric MRI (mpMRI) was shown to effectively measure changes in tumor characteristics after 6 months of neoadjuvant androgen deprivation therapy (ADT), indicating its potential as a biomarker for treatment response.

The study found that while certain mpMRI metrics (like Ktrans and AUC90) decreased post-treatment, the apparent diffusion coefficient (ADC) did not change, suggesting that mpMRI can provide valuable insights into tumor response and residual cancer burden, correlating well with pathology results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiparametric MRI as a Biomarker of Response to Neoadjuvant Therapy for Localized Prostate Cancer-A Pilot Study. Fennessy, FM., Fedorov, A., Vangel, MG., et al.[2021]

Multiparametric magnetic resonance imaging (mpMRI) can enhance the risk assessment for men with prostate cancer considering active surveillance (AS) by effectively visualizing high-grade tumors, which may lead to better patient selection compared to standard biopsy methods.

The high negative predictive value of mpMRI allows for the possibility of avoiding unnecessary repeat biopsies, while the presence of a positive lesion on mpMRI can indicate a higher risk of disease progression during AS, highlighting its role in monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of multiparametric magnetic resonance imaging in prostate cancer active surveillance. Glass, AS., Dall'Era, MA.[2020]

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]

Multiparametric magnetic resonance imaging (mpMRI) did not show significant differences in PI-RADS scores between patients eligible for active surveillance (AS) and those not eligible (NOT-AS), indicating that mpMRI alone may not effectively distinguish between these groups.

However, patients with a PI-RADS score of 5 had a high rate of unfavorable disease (83.3%) upon radical prostatectomy, suggesting that these lesions, particularly in the anterior part of the prostate, may indicate a need for more aggressive treatment rather than AS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complementing the active surveillance criteria with multiparametric magnetic resonance imaging. Kim, TU., Baek, SR., Song, WH., et al.[2023]

Multiparametric magnetic resonance imaging (mpMRI) significantly enhances the detection of clinically significant prostate cancer (csPCa) during biopsy, as shown by a study of 40 patients where 20% were diagnosed with PCa.

The use of mpMRI improved the decision-making process for biopsies, with an area under the curve (AUC) of 0.771 indicating good diagnostic performance, allowing for better patient management by identifying those who may not need a biopsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of individual prostate cancer via multiparametric magnetic resonance imaging in own material - initial experience. Porzycki, P., Ciszkowicz, E.[2022]

A consensus among 16 European prostate cancer experts established standardized methods for conducting and interpreting multiparametric MRI (mpMRI) to improve the detection and localization of clinically significant prostate cancer, focusing on key imaging sequences like T2-weighted, dynamic contrast-enhanced, and diffusion-weighted MRI.

The panel agreed on a structured 5-point scale to communicate the probability of malignancy, emphasizing the need for a minimum of 16 prostatic regions of interest in imaging, although these recommendations require further validation in prospective trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging for the detection, localisation, and characterisation of prostate cancer: recommendations from a European consensus meeting. Dickinson, L., Ahmed, HU., Allen, C., et al.[2022]

Multiparametric MRI (mpMRI) is a crucial tool for diagnosing and managing prostate cancer, showing significant growth and acceptance in the medical field over the past decade.

As the demand for prostate mpMRI increases globally, there is a pressing need to train specialized imagers to ensure high-quality imaging results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education of prostate MR imaging: commentary. Merritt, BA., Behr, SC.[2021]

Multiparametric magnetic resonance imaging (mpMRI) has become a crucial tool for detecting clinically significant prostate cancers and guiding biopsies, especially in high-risk populations.

The use of mpMRI in clinical practice has significantly influenced treatment decisions for men diagnosed with prostate cancer, marking a shift from traditional imaging methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiparametric prostate magnetic resonance imaging in the evaluation of prostate cancer. Turkbey, B., Brown, AM., Sankineni, S., et al.[2022]

Multiparametric magnetic resonance imaging (mpMRI) is a promising noninvasive technique for detecting and staging prostate cancer, addressing the limitations of traditional methods like digital rectal exams and biopsies.

mpMRI combines high-resolution anatomical imaging with functional assessments, making it effective for evaluating the aggressiveness of prostate cancer and monitoring treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiparametric MR Imaging for Detection and Locoregional Staging of Prostate Cancer. Bittencourt, LK., de Hollanda, ES., de Oliveira, RV.[2017]

References

1. 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]

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

The role of multi-parametric MRI in loco-regional staging of men diagnosed with early prostate cancer. [2015]

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

Evaluation of the accuracy of multiparametric MRI for predicting prostate cancer pathology and tumour staging in the real world: an multicentre study. [2020]

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

Evaluation of an Automated Analysis Tool for Prostate Cancer Prediction Using Multiparametric Magnetic Resonance Imaging. [2022]

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

Multiparametric MRI as a Biomarker of Response to Neoadjuvant Therapy for Localized Prostate Cancer-A Pilot Study. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Use of multiparametric magnetic resonance imaging in prostate cancer active surveillance. [2020]

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

Complementing the active surveillance criteria with multiparametric magnetic resonance imaging. [2023]

9. Poland pubmed.ncbi.nlm.nih.gov

Detection of individual prostate cancer via multiparametric magnetic resonance imaging in own material - initial experience. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging for the detection, localisation, and characterisation of prostate cancer: recommendations from a European consensus meeting. [2022]

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

Education of prostate MR imaging: commentary. [2021]

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

Multiparametric prostate magnetic resonance imaging in the evaluation of prostate cancer. [2022]

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

Multiparametric MR Imaging for Detection and Locoregional Staging of Prostate Cancer. [2017]