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MRI-Guided Radiation for Prostate Cancer

N/A

Recruiting

Led By Stanley Liauw

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

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

Must have

Histologically-confirmed, MRI-visible prostate adenocarcinoma with NCCN intermediate- or high-risk disease without extra-pelvic metastasis

Adult (≥ 18 years old) male patients with an ECOG Performance Status 0-2

Must not have

Additional active concurrent malignancies (except localized cutaneous squamous or basal cell carcinomas)

Distant metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 year after start of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial studies MRI to lower radiation dose to healthy prostate tissue while increasing dose to cancerous areas.

Who is the study for?

This trial is for men with prostate cancer. Participants should be suitable for radiation treatment and willing to undergo MRI scans. Specific details about inclusion and exclusion criteria are not provided, but typically these would relate to the stage of cancer, overall health, and prior treatments.

What is being tested?

The study is testing if using MRI can help target radiation more precisely in prostate cancer treatment—lowering doses to healthy areas while increasing it where the cancer is concentrated. This could improve safety and effectiveness.

What are the potential side effects?

Potential side effects may include typical reactions from radiation therapy such as fatigue, skin changes in treated area, urinary issues or bowel discomfort. Androgen Deprivation Therapy might cause hot flashes, reduced sexual desire or other hormonal changes.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer is visible on MRI, without spread beyond the pelvic area.

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I am a man over 18 and can care for myself.

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 other active cancers except for skin cancer.

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My cancer has spread to distant parts of my body.

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I have had radiation therapy to my pelvic area before.

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I am unable to understand and give consent for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 year after start of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 year after start of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year after start of treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Improvement in bowel related quality of life

Secondary study objectives

Biochemical control

Patient reported quality of life

Relationship between Imaging findings and Pathologic (tissue) findings

+1 more

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: Radiation therapyExperimental Treatment3 Interventions

Participants will receive MRI scan before starting Radiation treatment. The results of this scan will be used to identify areas of the prostate to receive low doses of radiation (areas that show no cancer cells seen by the MRI scan).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MRI

2009

Completed Phase 2

~2810

Radiation

2003

Completed Phase 2

~780