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Brachytherapy

MR-Guided Radiotherapy for Prostate Cancer

N/A

Waitlist Available

Led By Michael Zelefsky, M.D

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

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

Must have

Karnofsky Performance Status (KPS) > 80

Prostate size < 90 cc

Must not have

Prior or concurrent androgen deprivation therapy for prostate cancer

Evidence of metastatic disease on bone scan or MRI/CT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 12-18

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see how MR-guided radiotherapy affects tumor control in patients with intermediate risk prostate cancer by using ultra-hypofractionated external beam radiation therapy with a high-dose boost to

Who is the study for?

This trial is for patients with intermediate-risk prostate cancer. Participants should have a dominant lesion within the prostate visible on MRI. Key eligibility criteria include having a specific type of prostate cancer and being suitable for MR-guided radiotherapy.

What is being tested?

The study tests ultra-hypofractionated, MR-adaptive radiation therapy targeting the dominant intraprostatic lesion (DIL) using an advanced MR-Linac system, along with a hydrogel rectal spacer to minimize damage to surrounding tissues.

What are the potential side effects?

Potential side effects may include typical radiation therapy-related issues such as skin irritation, fatigue, urinary problems, bowel discomfort or changes in bowel habits due to the proximity of treatment area.

Eligibility Criteria

Inclusion Criteria

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

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I can carry out normal activities without assistance.

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My prostate is smaller than 90 cubic centimeters.

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My prostate symptoms are mild to moderate.

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My prostate cancer is classified as intermediate-risk.

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I am older than 18.

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My prostate cancer has a visible lesion larger than 0.5 cm and no more than two high-risk areas.

Exclusion Criteria

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

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I have received hormone therapy for prostate cancer.

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My scans show cancer has spread to my bones.

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My prostate cancer has a Gleason score above 7.

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I cannot have gadolinium contrast due to health reasons.

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My health limits my daily activities significantly.

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My scans show advanced prostate cancer.

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I have a history of inflammatory bowel disease.

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I am unable to understand and give consent for treatment.

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I have had radiation therapy to my pelvic area before.

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I have had surgery to remove part of my prostate.

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I have had a urethral stricture in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 12-18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, month 12-18

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 12-18 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Negative biopsy rate 24 months post-treatment

Serious toxicity rate 24 months post-treatment

Secondary study objectives

Change in GC Decipher score

Change in International Index of Erectile Function (IIEF) score

Change in International Prostate Symptom Score (I-PSS)

+3 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: MRI-guided Intensity Modulated RadiotherapyExperimental Treatment2 Interventions

All patients will undergo the injection of a hydrogel rectal spacer (SpaceOAR) 1 week before simulation. Patients will undergo ultra-hypofractionated radiation utilizing MR-guided, daily online adaptive planning. Patients will receive 9 Gy/fraction for five fractions for a total dose of 45 Gy to the prostate DIL while the rest of the prostate will be treated to a minimum dose to the rest of the prostate of 30 Gy in five fractions. Radiation will be given every other day, Monday through Friday, until 5 treatments have been completed. Patients will be followed at three and six months after treatment, and every six months thereafter through month 24 (+/- 4 weeks).

0 / 17Eligibility criteria met