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Radiation Therapy

SBRT vs Hypofractionated Radiotherapy for Recurrent 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

Must not have

Previous pelvic radiation

Prior systemic chemotherapy for prostate cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation therapy to my pelvic area before.

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I have had chemotherapy for prostate cancer before.

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I have had a procedure to widen the upper part of my urethra.

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I have not had a heart attack or severe heart failure in the last 6 months.

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My cancer has spread to more than 5 places in my body.

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I have had hormone therapy for prostate cancer and my PSA level is at least 0.1 ng/mL.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~790

Positron Emission Tomography

2011

Completed Phase 2

~2200