← Back to Search

Proton Beam Therapy

Proton Radiation Therapy for Prostate Cancer

N/A

Recruiting

Led By Pretesh R Patel

Research Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

Zubrod performance status 0-2

Clinically or pathologically positive regional lymph nodes within the inguinal, external iliac, internal iliac, obturator, peri-rectal, pre-sacral, common iliac, or lower para-oaortc (inferior to the L2-L3 interspace) basins

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is testing whether proton radiation therapy is an effective way to treat patients with high-risk or lymph node positive prostate cancer, with fewer side effects.

Who is the study for?

This trial is for men with high-risk prostate cancer, confirmed by pathology, who haven't had radical surgery or prior radiotherapy. They should have a Gleason grade of 8 or higher and may have lymph node involvement but no distant metastasis or bone metastasis. Participants need to be in good enough health to consent and follow the trial procedures.Check my eligibility

What is being tested?

The study is testing proton radiation therapy aimed at the prostate tumor and certain lymph nodes. It's compared with standard treatments to see if it can more effectively target tumors while causing fewer side effects like gastrointestinal and genitourinary issues.See study design

What are the potential side effects?

Proton beam therapy aims to minimize side effects by sparing healthy tissue; however, potential side effects might include irritation of the digestive tract, urinary complications, skin reactions in treated areas, fatigue, and other typical radiation-related symptoms.

Eligibility Criteria

Inclusion Criteria

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

Select...

I can take care of myself and am up more than 50% of my waking hours.

Select...

My cancer has spread to lymph nodes in the lower body area.

Select...

My cancer has spread to the seminal vesicles or is very advanced.

Select...

My prostate cancer is aggressive (Gleason grade 8+).

Select...

My PSA level is above 20, or above 10 if I'm taking finasteride.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acute grade 2+ gastrointestinal (GI) toxicity

Secondary outcome measures

Acute grade 2+ genitourinary (GU) toxicity rate

Biochemical failure

Chronic GI Toxicity

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (proton beam therapy)Experimental Treatment4 Interventions

Patients undergo conventionally fractionated proton beam therapy daily on Monday-Friday directed to the prostate, pelvic lymph nodes, and para-aortic lymph nodes. Patients may receive an optional high-dose rate brachytherapy boost. Androgen deprivation therapy is required.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

High-Dose Rate Brachytherapy

2004

Completed Phase 2

~530

Proton Beam Radiation Therapy

2013

Completed Phase 2

~110

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,640 Previous Clinical Trials

2,560,666 Total Patients Enrolled

17 Trials studying Prostate Cancer

7,157 Patients Enrolled for Prostate Cancer

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,824 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,095 Patients Enrolled for Prostate Cancer

Pretesh R PatelPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute

Media Library

Prostate Cancer Research Study Groups: Treatment (proton beam therapy)

Prostate Cancer Clinical Trial 2023: Proton Beam Radiation Therapy Highlights & Side Effects. Trial Name: NCT04725903 — N/A

Frequently Asked Questions

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

Are there any vacancies for willing participants in this experiment?

"Affirmative. The clinical trial is still recruiting participants, as evidenced by the information provided on clinicaltrials.gov. This medical experiment was originally posted on February 1st 2021 and has experienced subsequent updates that were made most recently on July 8th 2022. It requires 30 volunteers who will be trialed at a single site."

Answered by AI

What is the current size of the participant pool in this investigation?

"Verified. Data hosted on clinicaltrials.gov confirms that the outlined medical study, which was initially published on February 1st 2021, is actively enrolling patients. The trial site requires 30 participants from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Pretesh Patel 2021. "Proton Radiation Therapy for the Treatment of Patients With High Risk Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04725903.