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Proton Beam Therapy

High-Dose Radiation Therapy for Prostate Cancer

Phase 2

Recruiting

Led By Victoria Brennan, MBBCH BAO

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

Age ≥ 18

Karnofsky Performance Status (KPS) ≥ 80

Must not have

History of inflammatory bowel disease

Contra-indications to receiving gadolinium contrast

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether giving a higher dose of radiation to the main tumor will cure prostate cancer or prevent it from coming back.

Who is the study for?

Men over 18 with intermediate-risk prostate cancer can join this trial. They should have a PSA level of 10-20 ng/ml, Gleason score equal to 7, and clinical stage T2b/T2c. Their prostate size must be ≤80 cc with a visible lesion on MRI that's at least 0.5 cm. They need to be in good health (KPS ≥80), have mild urinary symptoms (IPSS ≤15), and meet specific MRI criteria without severe claustrophobia or metal implants that affect the scan.

What is being tested?

This study tests if giving a high 'boost' dose of radiation directly to the main tumor along with standard doses to the rest of the prostate is more effective in treating intermediate-risk prostate cancer than current methods. The goal is longer-lasting prevention of cancer return with minimal side effects.

What are the potential side effects?

Potential side effects from high-dose radiation may include skin changes, fatigue, frequent urination, painful urination, rectal bleeding or irritation, erectile dysfunction, and other urinary or bowel issues.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I can carry out normal activities with minimal symptoms.

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My prostate is 80 cc or smaller.

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My prostate cancer is at an intermediate stage with specific PSA, Gleason score, or clinical stage.

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I meet all MRI requirements and agree to complete the MRI form.

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My prostate symptoms are mild.

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My prostate cancer shows one main tumor larger than 0.5 cm and at most one small tumor.

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 cannot have MRI contrast dye due to health reasons.

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My prostate cancer has a Gleason score above 7.

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I have had surgery to remove part of my prostate.

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I have had radiation therapy to my pelvic area before.

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My daily activity is significantly limited by my health.

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My scans show advanced prostate cancer.

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I have had a urethral stricture in the past.

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

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My body size is too large for certain types of medical imaging.

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I have had hormone therapy for prostate cancer and my MRI shows possible cancer spread outside the prostate.

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My scans show cancer has spread to my bones.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Comparison of pretreatment biopsy with post-treatment biopsy

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: Prostate cancer patientsExperimental Treatment1 Intervention

Intermediate-risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines. Intermediate-risk patients will be defined as: * PSA 10-20 ng/ml or * Gleason score = 7 * Clinical stage T2b/T2c

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 19Eligibility criteria met