Multiparametric MRI After Radiotherapy for Prostate Cancer

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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to better understand prostate cancer changes after radiation treatment, through magnetic resonance imaging (MRI). MRI is an imaging test that allows doctors to see prostate gland without any operation procedures. It can help identifying the tumors in the prostate. For patients with newly diagnosed prostate cancer, MRI may help doctors manage treatment better and sooner.

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 data supports the effectiveness of the treatment 'Multiparametric MRI After Radiotherapy for Prostate Cancer'?

Research shows that multiparametric MRI (MP-MRI), which includes dynamic contrast-enhanced MRI (DCE-MRI), is effective in detecting and staging recurrent prostate cancer after radiotherapy. It helps in accurately identifying cancer recurrence, which can guide further treatment decisions. ^{1 2 3 4 5}

Is multiparametric MRI safe for humans after radiotherapy for prostate cancer?

Research on multiparametric MRI (mpMRI) and related techniques like dynamic contrast-enhanced MRI (DCE-MRI) and diffusion-weighted MRI (DW-MRI) in prostate cancer patients suggests these imaging methods are generally safe. They are used to monitor changes after radiotherapy and have been studied in various settings without significant safety concerns reported. ^{6 7 8 9 10}

How does multiparametric MRI after radiotherapy for prostate cancer differ from other treatments?

Multiparametric MRI (mp-MRI) after radiotherapy for prostate cancer is unique because it combines different imaging techniques, including T2-weighted, diffusion-weighted, and dynamic contrast-enhanced scans, to detect and stage recurrent cancer. This approach can identify cancer that might be missed by other imaging methods and helps in assessing the extent and aggressiveness of the disease after treatment. ^{2 5 11 12 13}

Research Team

Neelam Tyagi, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Recurrent prostate cancer after external beam radiotherapy: value of contrast-enhanced dynamic MRI in localizing intraprostatic tumor--correlation with biopsy findings. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Detection and staging of radio-recurrent prostate cancer using multiparametric MRI. [2022]

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

Response on DCE-MRI predicts outcome of salvage radiotherapy for local recurrence after radical prostatectomy. [2022]

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

3.0 T multiparametric prostate MRI using pelvic phased-array coil: utility for tumor detection prior to biopsy. [2016]

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

Multiparametric prostate MR imaging with T2-weighted, diffusion-weighted, and dynamic contrast-enhanced sequences: are all pulse sequences necessary to detect locally recurrent prostate cancer after radiation therapy? [2022]

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

Temporary Health Impact of Prostate MRI and Transrectal Prostate Biopsy in Active Surveillance Prostate Cancer Patients. [2020]

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

Magnetic resonance imaging radiomic features for recurrent prostate cancer following proton radiation therapy-A pilot study. [2023]

8. France pubmed.ncbi.nlm.nih.gov

Monitoring radiotherapy induced tissue changes in localized prostate cancer by multi-parametric magnetic resonance imaging (MP-MRI). [2020]

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

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

10. Germany pubmed.ncbi.nlm.nih.gov

Incremental value of diffusion weighted and dynamic contrast enhanced MRI in the detection of locally recurrent prostate cancer after radiation treatment: preliminary results. [2021]

11. India pubmed.ncbi.nlm.nih.gov

Evaluation of clinically significant prostate cancer using biparametric magnetic resonance imaging: An evolving concept. [2022]

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

Arguments against using an abbreviated or biparametric prostate MRI protocol. [2021]

13. France pubmed.ncbi.nlm.nih.gov

Prostate MRI: can we do without DCE sequences in 2013? [2016]