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Radiation Therapy

Group I (SBRT) for Prostate Cancer

Phase 3

Recruiting

Led By Carlos E. Vargas, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Histologically confirmed prostate adenocarcinoma at the time of surgery

Patients must be ≥ 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is comparing two types of radiation therapy for treating patients with prostate cancer that has come back or has spread to a limited number of sites. One type, called stereotactic body radiation therapy (

Who is the study for?

This trial is for men with prostate adenocarcinoma that has either returned after initial treatment or spread to a few other places. Participants should have undergone some prior therapy and be able to undergo imaging tests like PET scans, bone scans, and MRIs.Check my eligibility

What is being tested?

The study compares two radiation therapies: SBRT, which delivers precise doses over several days aiming to minimize damage to healthy tissue; versus hypofractionated radiotherapy, which gives higher doses in a shorter time frame potentially killing more tumor cells.See study design

What are the potential side effects?

Possible side effects include skin reactions at the treatment site, fatigue, urinary issues such as increased frequency or discomfort, bowel changes like diarrhea or pain during bowel movements, and erectile dysfunction.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer was confirmed through a tissue examination.

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I am 18 years old or older.

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My prostate cancer has spread to no more than 5 places.

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My cancer is at a specific stage according to my pathology report.

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My PSA level is between 0.1 and 2.0 ng/mL after prostate surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Incidence of grade 3 or higher genitourinary (GU)/gastrointestinal (GI) radiation treatment-related adverse events

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group II (Hypofractionated radiation therapy)Experimental Treatment7 Interventions

Patients undergo hypofractionated radiation therapy over 15-20 minutes once per day for a total of 20 treatments over 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive androgen deprivation therapy for up to 18 months, as clinically indicated. Patients undergo bone scan and PET at screening and treatment failure, and undergo MRI and blood sample collection throughout the study.

Group II: Group I (SBRT)Experimental Treatment7 Interventions

Patients undergo SBRT over 15-20 minutes every other day for a total of 5 treatments over 1-2 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive androgen deprivation therapy for up to 18 months, as clinically indicated. Patients undergo bone scan and PET at screening and treatment failure, and undergo MRI and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Antiandrogen Therapy

2015

Completed Phase 1

~10

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~780

Positron Emission Tomography

2008

Completed Phase 2

~2240

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Biospecimen Collection

2004

Completed Phase 2

~1700

Hypofractionated Radiation Therapy

2016

Completed Phase 2

~130

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,216 Previous Clinical Trials

3,767,370 Total Patients Enrolled

34 Trials studying Prostate Cancer

8,388 Patients Enrolled for Prostate Cancer

Carlos E. Vargas, M.D.Principal InvestigatorMayo Clinic

5 Previous Clinical Trials

311 Total Patients Enrolled

Frequently Asked Questions

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

Is the enrollment process currently in progress for participants of this research study?

"According to the information provided on clinicaltrials.gov, this particular trial is not currently accepting new participants. The trial was first posted on February 9th, 2024 and was last updated on January 4th, 2024. However, it's worth noting that there are a total of 4933 other ongoing clinical trials actively recruiting participants at this time."

Answered by AI

Has the United States Food and Drug Administration granted official approval to Group I (SBRT) treatment?

"Due to the availability of data supporting efficacy and multiple rounds of safety data, Group I (SBRT) has been assigned a safety rating of 3 by our team at Power."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma

2024. "SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06205316.

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