High Five Trial: High-Risk Prostate Cancer

What is the Purpose of this Study?

The purpose of this study is to compare 2 radiation schedules that can be used to treat patients with high-risk prostate cancer. One approach delivers a higher dose of radiation per treatment and uses fewer treatments over a shorter length of time (called stereotactic body radiation therapy-SBRT). The other delivers a lower dose of radiation per treatment but for more treatments over a longer time, which is a more standard approach. SBRT delivers the high dose of radiation more precisely to the tumor to spare normal tissue. The study will determine whether a higher dose/shorter course treatment is as effective as the lower dose/longer course treatment plan. Participants will be randomly assigned to 1 of 2 groups: the study approach (higher dose/shorter course), or the usual radiation therapy (lower dose/longer course).


Eligibility

  • * Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer
  • * High-risk disease defined as having at least one or more of the following:
  • * cT3a-T3b by digital exam or imaging (American Joint Committee on Cancer \[AJCC\] 8th edition \[Ed.\]) Note: cT4 by imaging or on digital rectal exam is not allowed
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Where can I participate?

  • CS Cancer at Beverly Hills
  • CS Cancer at Cedars-Sinai Medical Center


More about this Clinical Trial

What is the full name of this clinical trial?

NRG-GU013: The Phase III High Five Trial Five Fraction Radiation For High-Risk Prostate Cancer

Study Details
Disease Type/Condition

Prostate

Principal Investigator

Ballas, Leslie

Co-Investigators

Andrew Horodner, Andrew Schumacher, Anthony Nguyen, Bryan Chang, David Chan, Edwin Posadas, Howard Sandler, Hugo Hool, Jeremy Lorber, Jun Gong, Justin Wayne Tiulim, Kevin Scher, Mitchell Kamrava, Swati Sikaria, Syed Jilani, Thomas Lowe, Thyra Endicott, Usama Mahmood, Zachary Zumsteg

Age Group

Adult

Phase

III

IRB Number

STUDY00003636

ClinicalTrials.gov ID

NCT05946213

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Prostate

Principal Investigator

Ballas, Leslie

Age Group

Adult

Phase

III

IRB Number

NRG-GU013

ClinicalTrials.gov ID

NCT05946213

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org