RecruitingNot ApplicableNCT04725903

Proton Radiation Therapy for the Treatment of Patients With High Risk Prostate Cancer

Extended-Field Lymph Node Proton Irradiation for High Risk Prostate Cancer


Sponsor

Emory University

Enrollment

30 participants

Start Date

Feb 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial investigates whether proton radiation therapy directed to the prostate tumor, pelvic, and para-aortic lymph nodes, is an effective way to treat patients with high-risk or lymph node positive prostate cancer who are receiving radiation therapy, and if it will result in fewer gastrointestinal and genitourinary side effects. Proton beam therapy is a new type of radiotherapy that directs multiple beams of protons (positively charged subatomic particles) at the tumor target, where they deposit the bulk of their energy with essentially no residual radiation beyond the tumor. By reducing the exposure of the healthy tissues and organs to radiation in the treatment of prostate cancer, proton therapy has the potential to better spare healthy tissue and reduce the side effects of radiation therapy.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates the use of proton radiation therapy — a precise form of radiation — for men with high-risk prostate cancer. Proton therapy can target tumors more accurately and may reduce damage to nearby healthy tissue compared to standard radiation. **You may be eligible if:** - You have pathologically confirmed high-risk prostate cancer, defined by a Gleason score of 8 or higher, cancer that has grown into the seminal vesicles (cT3b) or beyond (cT4), a PSA over 20, or cancer that has spread to regional lymph nodes - You have adequate blood counts - You are able to give informed consent **You may NOT be eligible if:** - You have bone metastases or distant lymph node metastases - You have previously had a prostatectomy, cryotherapy, or prior radiation to the prostate area - You have uncontrolled illness such as inflammatory bowel disease, active infection, or severe heart or psychiatric conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHigh-Dose Rate Brachytherapy

Receive high-dose rate brachytherapy boost

RADIATIONProton Beam Radiation Therapy

Undergo proton beam therapy

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERSurvey Administration

Ancillary studies


Locations(1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

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NCT04725903


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