Multiparametric MRI After Radiotherapy for Prostate Cancer

Not currently recruiting at 8 trial locations

Overseen By Michael Zelefsky, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Radical prostatectomy, Metastatic disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how prostate cancer changes after radiation treatment using advanced MRI scans. MRI (magnetic resonance imaging) is a non-invasive test that allows doctors to examine the prostate gland and identify tumors without surgery. The study aims to use MRI to help doctors manage treatment more effectively for patients with newly diagnosed prostate cancer. Ideal candidates are those diagnosed with prostate cancer, planning to undergo specific types of radiation therapy, and willing to have MRI scans as part of their treatment at the MSK Main Campus.

As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to advancements in prostate cancer care.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that patients who will receive hormonal therapy are eligible, suggesting that some treatments may continue.

What prior data suggests that multiparametric MRI is safe for prostate cancer patients?

Research has shown that multiparametric MRI (MP-MRI) is a safe and well-tolerated method for managing prostate cancer. Studies have found that MP-MRI aids in diagnosing prostate cancer and making treatment decisions. It presents no major safety concerns. In one study, many participants avoided unnecessary biopsies, indicating that MP-MRI can safely reduce the need for invasive procedures.

Moreover, MP-MRI is already a standard part of prostate cancer care, underscoring its safety and effectiveness. No significant reports of negative side effects have been linked to MP-MRI, making it a dependable option for imaging in prostate cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using multiparametric MRI (MP-MRI) after radiotherapy for prostate cancer because it offers a non-invasive way to monitor treatment effectiveness over time. Unlike traditional methods that rely heavily on post-treatment biopsies, MP-MRI allows doctors to visualize changes in the prostate with advanced imaging techniques, providing real-time insights into how well the cancer is responding to treatment. This approach could potentially reduce the need for invasive procedures and offer a more accurate assessment of local cancer control, helping to tailor future treatments more precisely.

What evidence suggests that multiparametric MRI is effective for understanding prostate cancer changes after radiotherapy?

Research has shown that multiparametric MRI (MP-MRI) is a valuable tool for diagnosing and managing prostate cancer. Studies have found that combining MP-MRI with traditional biopsy methods can reduce deaths by 126 and 118 per 100,000 people, depending on the method used. This imaging technique helps doctors locate tumors more accurately and assess the risk and stage of the disease. In this trial, participants will undergo MP-MRI at various intervals after radiotherapy to monitor treatment effects. These findings suggest that MP-MRI could improve prostate cancer outcomes by aiding doctors in making better treatment decisions. ^{3 6 7 8 9}

Who Is on the Research Team?

Neelam Tyagi, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for men over 18 with confirmed prostate adenocarcinoma, planning to undergo various forms of radiotherapy. They must have a visible tumor on MRI and can't have had hormone therapy in the last month. It's not for those with metallic pelvic implants, gadolinium contrast issues, metastatic disease, or conditions preventing MRI use like pacemakers.

Inclusion Criteria

I have prostate cancer confirmed by biopsy and will receive specific types of radiation therapy.

I haven't had hormone therapy for cancer in the last month.

Willing to come to MSK Main Campus for baseline and follow-up MP-MRIs.

Exclusion Criteria

I do not have any metallic implants in my hip or pelvis that could affect MRI quality.

I cannot have gadolinium contrast due to health reasons.

Patients who are unwilling or unable to undergo MRI including patients with contraindications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants undergo radiotherapy treatment for prostate cancer

Duration not specified

Follow-up

Participants undergo follow-up MRIs at approximately 3, 6, 12, 18, and 24 months after radiotherapy to monitor changes in tumor characteristics

24 months

5 visits (in-person)

Biopsy

A standard post-treatment biopsy is performed at 24 months to assess local control status

1 visit

What Are the Treatments Tested in This Trial?

Interventions

• biopsy
• dynamic contrast-enhanced MRI (DCE)
• multi-parametric MRI(MP-MRI)

Trial Overview The study uses advanced MRI techniques (MP-MRI and DCE) to monitor prostate cancer response after radiation treatments. The goal is to improve how doctors assess changes in the tumor post-therapy which could lead to better treatment management.

How Is the Trial Designed?

Group I: Multiparametric MRI Experimental Treatment 3 Interventions

Patients undergo baseline standard (clinical) MP-MRI prior to therapy (ADT or RT). After completion of radiotherapy, follow-up MRIs will be obtained using the same 3T Philips MRI unit at approximately 3, 6, 12, 18 \& 24 (+/- 4 weeks) months after radiotherapy. A standard post-tx biopsy will be performed at 24 months (+/- 4 weeks) after therapy which will serve to define the local control status after therapy. Local control based on this biopsy will be interpreted as negative or adenoca with severe tx effect; a positive biopsy will be a specimen which demonstrates adenocarcinoma that can be classified with a Gleason score as we have previously reported.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4495493/

Multiparametric-MRI in diagnosis of prostate cancer - PMC Multiparametric-magnetic resonance imaging (mp-MRI) has shown promising results in diagnosis, localization, risk stratification and staging of clinically ...

2. dirjournal.org dirjournal.org/articles/long-term-follow-up-results-of-multiparametric-prostate-mri-and-the-prognostic-value-of-pi-rads-a-single-center-retrospective-cohort-study/dir.2023.232414

Long-term follow-up results of multiparametric prostate MRI ... Among cases that were downgraded to PI-RADS 2–3, malignancy was observed in 23%, whereas 62.5% of cases with persistent lesions were diagnosed ...

3. urotoday.com urotoday.com/conference-highlights/eau-2024/eau-2024-prostate-cancer/150992-eau-2024-comparison-of-biparametric-and-multiparametric-mri-for-prostate-cancer-detection-the-prime-study.html

Comparison of Biparametric and Multiparametric MRI for ... Biparametric MRI is non-inferior to multiparametric MRI for clinical significant prostate cancer diagnosis, with no increase in number of men with a biopsy ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2021.39.6_suppl.224

Effectiveness of early diagnosis for prostate cancer based ... Using mpMRI was estimated to result in an additional 126 and 118 fewer deaths per 100,000 if mpMRI was used in conjunction with SB (S2) or with ...

5. auanet.org auanet.org/guidelines-and-quality/guidelines/other-clinical-guidance/mri-of-the-prostate-sop

Prostate Cancer Multi-parametric MRI (mpMRI) has been proven to be a valuable tool in the diagnostic and management pathway in men at risk of prostate cancer.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6309696/

Multiparametric MRI and prostate cancer diagnosis and risk ... We will review multiparametric MRI (MP-MRI) for localized prostate cancer, emphasizing its potential role in risk stratification and improving outcomes.

7. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2827887

Oncological Safety of MRI-Informed Biopsy Decision ... Findings In this cohort study involving 593 biopsy-naive men, 48% had negative MRI results, 86% of whom avoided biopsy over 3 years. After 3 ...

8. pubs.rsna.org pubs.rsna.org/doi/10.1148/rycan.240269

Multiparametric MRI before and after Focal Therapy for ... mpMRI consistently underestimates the size and extent of prostate cancer, particularly for larger tumors and tumors containing high-grade cancer ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0302283820302104

Prostate Cancer Five-year Outcomes of Magnetic ... Primary outcomes were event-free survival (EFS; event defined as prostate cancer treatment, transition to watchful waiting, or death) and treatment-free ...