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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Malignant neoplasm of prostate
Secondary outcome measures
The secondary aim is to obtain quality of life data to examine the potential complications associated with SBRT: detailed symptom questionnaire
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.
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Who is running the clinical trial?
Hoag Memorial Hospital PresbyterianLead Sponsor
34 Previous Clinical Trials
14,595 Total Patients Enrolled
1 Trials studying Prostate Cancer
184 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to distant parts of my body.My cancer is in an early to mid-stage, not the most advanced.There are no restrictions based on your life expectancy.My cancer has spread to nearby lymph nodes.I have had surgery or specific treatments for prostate cancer.I have had a physical exam that included a prostate check.I am a man aged 18 or older.I have had chemotherapy for prostate cancer.My prostate cancer diagnosis was confirmed through a tissue examination.My prostate biopsy was analyzed and given a Gleason score.I do not have severe inflammatory bowel disease.I have had radiation therapy to my pelvis or seed implantation in my prostate.
Research Study Groups:
This trial has the following groups:- Group 1: Agility Systems
- Group 2: Elekta Versa HD
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have any new participants been welcomed into this research endeavor recently?
"According to the clinicaltrials.gov website, this study has not been actively recruiting since March 14th 2022. Although recruitment for this trial is currently paused, there are 1,322 other medical trials looking for volunteers right now."
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