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Radiation Therapy

SBRT for Prostate Cancer

N/A

Waitlist Available

Research Sponsored by Hoag Memorial Hospital Presbyterian

Eligibility Criteria Checklist

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

Must have

Clinical stage T1-3 (AJCC 7th edition).

Males age ≥ 18

Must not have

Evidence of distant metastases

Regional lymph node involvement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the long term efficacy and side effects of SBRT done with the Elekta Versa or Agility System versus the standard EBRT.

Who is the study for?

This trial is for men over 18 with early to moderately advanced prostate cancer (stage T1-3) who haven't had previous treatments like surgery, cryosurgery, or radiation. They must be able to consent and fill out a quality of life questionnaire. Men with distant metastases, lymph node involvement, severe bowel disease, or prior chemotherapy are excluded.

What is being tested?

The study tests the effectiveness and side effects of Stereotactic Body Radiation Therapy (SBRT) using Elekta Versa or Agility Systems in treating prostate cancer. SBRT is an advanced technique delivering targeted radiation in fewer sessions compared to traditional therapy—5 versus 42-45 treatments.

What are the potential side effects?

Potential side effects include typical reactions from radiation such as skin irritation near the treatment area, fatigue, urinary issues like 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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My cancer is in an early to mid-stage, not the most advanced.

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I am a man aged 18 or older.

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My prostate cancer diagnosis was confirmed through a tissue examination.

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My prostate biopsy was analyzed and given a Gleason score.

Exclusion Criteria

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

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My cancer has spread to distant parts of my body.

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My cancer has spread to nearby lymph nodes.

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I have had surgery or specific treatments for prostate cancer.

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I have had chemotherapy for prostate cancer.

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I have had radiation therapy to my pelvis or seed implantation in my prostate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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

Malignant neoplasm of prostate

Secondary study objectives

The secondary aim is to obtain quality of life data to examine the potential complications associated with SBRT: detailed symptom questionnaire

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Agility SystemsExperimental Treatment1 Intervention

This study seeks to investigate biochemical failure rates for patients treated with SBRT utilizing Agility Systems, as well as obtain quality of life data and assess the intrafraction motion in approximately 15 patients for 5 years following SBRT.

Group II: Elekta Versa HDActive Control1 Intervention

This study seeks to investigate biochemical failure rates for patients treated with SBRT utilizing Elekta machines, as well as obtain quality of life data and assess the intrafraction motion in approximately 15 patients for 5 years following SBRT.

0 / 9Eligibility criteria met