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Radiation Therapy

Intensity-Modulated Radiotherapy for Prostate Cancer

Phase 1
Waitlist Available
Led By Daniel Gorovets, 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
Intermediate risk prostate cancer patients as per NCCN guidelines with PSA 10-20 ng/ml or Gleason score = 7 or Clinical stage T2b/T2c
International Prostate Symptom Score < 15
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trial is testing a new, shorter course of radiation therapy for prostate cancer. They want to see if it is just as effective as the current standard of care, but with fewer side effects.

Who is the study for?
Men over 18 with intermediate risk prostate cancer, defined by specific PSA levels, Gleason score, and clinical stage. They must have a dominant prostatic lesion of a certain size and no more than two smaller disease foci. Participants need good physical function (KPS > 80), prostate size < 60cc, manageable urinary symptoms, and must pass MRI screening without contraindications like metallic implants or severe claustrophobia.Check my eligibility
What is being tested?
The trial is testing ultra-hypofractionated radiotherapy targeting the prostate and its main tumor site in men with intermediate-risk prostate cancer. The goal is to assess the treatment's feasibility and effectiveness as a definitive therapy using advanced MR-based imaging techniques for precise delivery.See study design
What are the potential side effects?
Potential side effects may include skin reactions in treated areas, fatigue, urinary issues such as increased frequency or discomfort during urination, bowel changes like diarrhea or rectal bleeding, erectile dysfunction due to nerve damage around the prostate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer is at an intermediate risk level with specific PSA, Gleason score, or stage.
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My prostate symptoms are mild.
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My prostate is smaller than 60cc.
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I am older than 18 years.
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I can carry out normal activities without significant restrictions.
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My prostate cancer has one main tumor larger than 0.5cm and up to two smaller tumors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment related toxicity of ultra-hypofractionated radiotherapy will be assessed according to NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity

Trial Design

1Treatment groups
Experimental Treatment
Group I: MR Image Guided, Intensity-Modulated RadiotherapyExperimental Treatment1 Intervention
Patients enrolled in this study will undergo MR-based, image-guided, intensity-modulated radiotherapy using similar equipment, techniques, and treatment-planning procedures as currently practiced at MSKCC.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,927 Previous Clinical Trials
591,372 Total Patients Enrolled
131 Trials studying Prostate Cancer
65,869 Patients Enrolled for Prostate Cancer
Daniel Gorovets, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
326 Total Patients Enrolled
3 Trials studying Prostate Cancer
326 Patients Enrolled for Prostate Cancer
Michael Zelefsky, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
11 Previous Clinical Trials
1,007 Total Patients Enrolled
8 Trials studying Prostate Cancer
700 Patients Enrolled for Prostate Cancer

Media Library

Ultra-hypofractionated Radiotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03269422 — Phase 1
Prostate Cancer Research Study Groups: MR Image Guided, Intensity-Modulated Radiotherapy
Prostate Cancer Clinical Trial 2023: Ultra-hypofractionated Radiotherapy Highlights & Side Effects. Trial Name: NCT03269422 — Phase 1
Ultra-hypofractionated Radiotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03269422 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment open to new participants at present?

"This clinical trial, which was first made public on August 28th 2017, is not currently accepting patients. However, according to clinicaltrials.gov there are 1,321 other studies actively recruiting individuals at this time."

Answered by AI

Are there multiple sites administering this research in the state?

"Currently, there are 7 locations enrolling patients in this trial. These include Memorial Sloan Kettering Nassau (Uniondale) and Memorial Sloan Kettering Basking Ridge (Basking Ridge), as well as 5 additional medical sites."

Answered by AI

To what extent could MR-based image-guided, intensity-modulated radiotherapy jeopardize a patient's health?

"Due to the limited evidence of safety and effectiveness, MR-based image-guided, intensity-modulated radiotherapy was rated a 1 on our team's scale."

Answered by AI
~2 spots leftby Aug 2024