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Radiation Therapy

Hypofractionated Radiation Therapy for Prostate Cancer

Phase 1

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

Low risk prostate cancer patients: PSA < or = to 10 ng/ml, Gleason score = 6, Clinical Stage < or = to T2a

Intermediate risk prostate cancer patients: PSA 10-20 ng/ml, Gleason score = 7, Clinical stage T2b/T2c

Must not have

History of inflammatory bowel disease

Unable to give informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if it's safe to give a higher dose of radiation during each treatment day for cancer, which would reduce the number of treatments from 48 to 5.

Who is the study for?

Men aged 18 or older with low to intermediate risk prostate cancer, defined by specific PSA levels, Gleason scores, and clinical stages. They must have a good performance status (able to carry out daily activities), no severe urinary symptoms, a prostate size ≤60 cc, and no evidence of advanced disease on MRI/CT scans.

What is being tested?

The trial is testing an advanced form of radiation therapy for prostate cancer called ultra-hypofractionated IG-IMRT. It involves fewer treatment sessions (5 over two weeks) with higher doses each time compared to the standard 45-48 treatments.

What are the potential side effects?

Potential side effects may include skin reactions in the treated area, fatigue, urinary issues such as increased frequency or discomfort during urination, bowel changes like diarrhea or rectal bleeding, and erectile dysfunction.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer is low risk with a PSA of 10 or less, Gleason score of 6, and stage T2a or lower.

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My prostate cancer is at an intermediate stage with specific PSA levels and Gleason score.

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I am 18 years old or older.

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I am mostly able to care for myself.

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My prostate symptoms are mild.

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My prostate is 60 cc or smaller.

Exclusion Criteria

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

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I have a history of inflammatory bowel disease.

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I am unable to understand and agree to the study's details on my own.

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I am choosing to have radiation therapy on my pelvic lymph nodes.

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I have had a urethral stricture in the past.

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I have had radiation therapy to my pelvic area before.

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My physical condition limits my ability to care for myself.

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My scans show my cancer has spread to nearby tissues or lymph nodes.

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My cancer has spread to distant parts of my body, confirmed by specific tests.

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I have had surgery to remove part of my prostate.

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I have undergone hormone therapy for prostate cancer.

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I have a history of long-term prostate inflammation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: RadiationExperimental Treatment1 Intervention

Patients enrolled in the study will undergo image-guided, intensity-modulated radiotherapy using the same equipment, techniques, and treatment-planning procedures as currently practiced as MSKCC. MSKCC patients will have the option of continued follow-up through MSKCC's established Prostate Survivorship Clinic for an indefinite period of time, meaning patients enrolled in the protocol will be encouraged to remain at MSKCC for life-long follow-up after their treatment. The standard assessments obtained in the Survivorship Clinic will not be altered. All protocol relevant data collected at these visits through month 60 will be used for protocol analysis.

0 / 17Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,979 Previous Clinical Trials

599,718 Total Patients Enrolled

55 Trials studying Adenocarcinoma

9,847 Patients Enrolled for Adenocarcinoma

Montefiore Medical CenterOTHER

458 Previous Clinical Trials

588,494 Total Patients Enrolled

1 Trials studying Adenocarcinoma

22 Patients Enrolled for Adenocarcinoma

Michael Zelefsky, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

11 Previous Clinical Trials

819 Total Patients Enrolled

Sean McBride, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

$Hypofractionated, image-guided, intensity-modulated external beam radiation (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00911118 — Phase 1$

Adenocarcinoma Research Study Groups: Radiation

$Adenocarcinoma Clinical Trial 2023: Hypofractionated, image-guided, intensity-modulated external beam radiation Highlights & Side Effects. Trial Name: NCT00911118 — Phase 1$

$Hypofractionated, image-guided, intensity-modulated external beam radiation (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00911118 — Phase 1$