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Proton Beam Therapy

Radiation + Androgen Suppression for Prostate Cancer

Phase 3
Recruiting
Led By Carlos Vargas, MD
Research Sponsored by Proton Collaborative Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be at least 18 years old
Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range of 2-7. > 6 cores are strongly recommended
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after the initial 100 patients have had a median follow up of at least three years and then every year.
Awards & highlights

Study Summary

This trial will compare the effectiveness of two treatments for prostate cancer.

Who is the study for?
Men with intermediate-risk prostate cancer who have not had previous prostate surgery, androgen suppression therapy, or pelvic radiation. They must be in good physical condition (ECOG 0-1), have a Gleason Score of 7, PSA levels between 10-20 ng/ml, T stage T2b-T2c, and no major medical issues that could affect the study.Check my eligibility
What is being tested?
The trial is testing hypofraction proton therapy alone versus proton therapy combined with androgen suppression. Participants will receive either just the radiation treatment or both treatments to see which is more effective at treating localized prostate cancer.See study design
What are the potential side effects?
Potential side effects include skin reactions from radiation like redness or irritation, fatigue due to treatment stress on the body, urinary issues such as increased frequency or discomfort during urination, bowel changes including diarrhea or rectal discomfort.

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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My prostate cancer has a Gleason score between 2 and 7, based on more than 6 biopsy samples.
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My breast cancer is in an early stage and has not spread to lymph nodes or other parts of my body.
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My prostate is smaller than 55cc before starting active surveillance.
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My prostate cancer is at intermediate risk of coming back, confirmed by tests within the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after the initial 100 patients have had a median follow up of at least three years and then every year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and after the initial 100 patients have had a median follow up of at least three years and then every year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Morbidity Outcomes
Secondary outcome measures
Correlate PSA and free PSA levels with outcomes
Correlate pathologic and radiologic findings with outcomes
Correlate testosterone levels and variation with proton therapy and outcomes
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Radiation + Androgen SuppressionExperimental Treatment2 Interventions
Androgen Suppression Therapy x 6 months + Radiation
Group II: Radiation AloneActive Control1 Intervention
Proton Radiation Total Dose=70 Gy(RBE) OR High Dose Radiation with IMRT Alone=81 Gy OR Intraoperative LDR Brachytherapy and IMRT=45 Gy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation
2003
Completed Phase 3
~1020

Find a Location

Who is running the clinical trial?

Proton Collaborative GroupLead Sponsor
9 Previous Clinical Trials
40,942 Total Patients Enrolled
3 Trials studying Prostate Cancer
222 Patients Enrolled for Prostate Cancer
Carlos Vargas, MDPrincipal InvestigatorProton Collaborative Group
4 Previous Clinical Trials
40,167 Total Patients Enrolled
2 Trials studying Prostate Cancer
152 Patients Enrolled for Prostate Cancer

Media Library

Proton Beam Radiation Therapy (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01492972 — Phase 3
Prostate Cancer Research Study Groups: Radiation Alone, Radiation + Androgen Suppression
Prostate Cancer Clinical Trial 2023: Proton Beam Radiation Therapy Highlights & Side Effects. Trial Name: NCT01492972 — Phase 3
Proton Beam Radiation Therapy (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01492972 — Phase 3

Frequently Asked Questions

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

What is the maximum dosage of radiation that a patient can receive safely?

"Radiation has been studied relatively extensively, so it's been given a safety score of 3."

Answered by AI

Are new participants being accepted into this clinical trial?

"Yes, that is accurate. The information hosted on clinicaltrials.gov supports that this trial is still recruiting patients. The original posting date was January 1st, 2012 and the data was last updated on October 24th, 2021. A total of 192 individuals are needed for the study across 6 sites."

Answered by AI

What other similar medical trials have been conducted in the past?

"Radiation has been studied since the year 2000, when AstraZeneca first sponsored a trial of the medication. That initial study had 600 participants. After that Phase 3 drug approval was received in 2000, there are now 120 ongoing clinical trials for Radiation being conducted in 59 different nations and across 1596 cities."

Answered by AI

What are the benefits of Radiation therapy?

"Radiation is an effective treatment for breast cancer, endometrial thinning, and other health concerns."

Answered by AI

What is the body of research on Radiation like?

"The first scientific research on radiation was conducted in 2000 at Centre de Recherche Clinique du CHUS. In the two decades since, there have been a total of 331 completed trials. Right now, 120 live clinical trials are ongoing, with a notable concentration in Oklahoma City, Oklahoma."

Answered by AI

At how many locations is this experiment being conducted?

"To make participation more convenient for patients, this clinical trial is being conducted at 6 different sites. These facilities are situated in Oklahoma City, Scottsdale, Warrenville and other locations."

Answered by AI

What is the total number of people participating in this clinical trial?

"In order to run this clinical trial, we require 192 participants that fit the pre-specified inclusion criteria. Patients can travel to ProCure Proton Therapy Center in Oklahoma City, Oklahoma or Oklahoma Proton Center in Scottsdale, Arizona in order to take part."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
California Protons Cancer Therapy Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer
2012. "Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01492972.
All > Oklahoma > Paid Studies California
~22 spots leftby Dec 2025
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