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Multiparametric MRI After Radiotherapy for Prostate Cancer

Phase 2

Waitlist Available

Led By Michael Zelefsky, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with biopsy proven (completed and/or reviewed at MSK) adenocarcinoma of the prostate, who will undergo external beam radiotherapy using conventional fractionation IGRT including moderate hypofractionated radiation, low rate brachytherapy alone, brachytherapy (either high dose or low dose) combined with supplemental image guided radiation (including IGRT, EBRT, and SBRT), SBRT, or proton radiotherapy.

Age ≥ 18 years old

Must not have

Patients with a metallic hip implant, metallic implant or device in the pelvis or ferromagnetic fiducial beacons (Calypso) that might distort local magnetic field and compromise quality of MP-MRI

Patients in which gadolinium contrast is contra-indicated.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 24 months after completion of radiotherapy

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if MRI can help manage prostate cancer treatment better and sooner for patients who have newly diagnosed prostate cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on imaging rather than medication or invasive procedures, typical drug-related side effects are not expected. However, patients may experience discomfort from lying still during MRIs or anxiety if claustrophobic.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I cannot have gadolinium contrast due to health reasons.

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I have had surgery to remove my prostate.

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My cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 24 months after completion of radiotherapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 24 months after completion of radiotherapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 24 months after completion of radiotherapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

characterize the changes in tumor characteristics by functional imaging changes with post-treatment prostate biopsy outcomes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

biopsy

2002

Completed Phase 4

~8270

0 / 6Eligibility criteria met