Multiparametric MRI After Radiotherapy for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen byNeelam Tyagi, PhD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

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.

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.

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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.

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Treatment Details

Interventions

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

Trial OverviewThe 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

1Treatment groups

Experimental Treatment

Group I: Multiparametric MRIExperimental Treatment3 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.