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Radiation Therapy

stereotactic body radiation therapy (SBRT) - 47.5 Gy for Prostate Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Gleason score ≤ 7
Stage T2a or T2b
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights

Study Summary

This trial is testing a new way to give radiation for prostate cancer that may cause less damage to normal tissue.

Eligible Conditions
  • Prostate Cancer

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
No. of Late Severe GI Toxicity (for Phase 2 Only)
No. of Late Severe GU Toxicity (for Phase 2 Only)
Number of Participants With Dose Limiting Toxicity (Phase 1 Only)
Secondary outcome measures
Clinical Progression Including Local/Regional and Distant Relapse
Disease Specific Survival
Freedom From Biochemical Failure
+5 more

Side effects data

From 2022 Phase 1 & 2 trial • 94 Patients • NCT00547339
53%
Rectal Toxicity
33%
Urinary Frequency
20%
Urinary Urgency
20%
Urinary Incontinence
7%
Dysuria
7%
Cystitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1: SBRT- 47.5 Gy
Phase 1: SBRT- 45 Gy
Phase 1: SBRT- 50 Gy
Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy

Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 GyExperimental Treatment1 Intervention
The dose of SBRT is escalated - 50 Gy in Phase 2
Group II: Phase 1: Stereotactic Body Radiation Therapy (SBRT)- 50 GyExperimental Treatment1 Intervention
The Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated- 50 Gy
Group III: Phase 1: Stereotactic Body Radiation Therapy (SBRT)- 47.5 GyExperimental Treatment1 Intervention
The Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated- 47.5 Gy
Group IV: Phase 1: Stereotactic Body Radiation Therapy (SBRT) 45 GyExperimental Treatment1 Intervention
The Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated - 45 Gy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
stereotactic body radiation therapy (SBRT) - 47.5 Gy
2006
Completed Phase 2
~100
stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2)
2006
Completed Phase 2
~100
stereotactic body radiation therapy (SBRT)- 45 Gy
2006
Completed Phase 2
~100
stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 1)
2006
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,039 Previous Clinical Trials
1,048,005 Total Patients Enrolled
15 Trials studying Prostate Cancer
2,041 Patients Enrolled for Prostate Cancer
Robert D. Timmerman, MDStudy ChairSimmons Cancer Center
9 Previous Clinical Trials
368 Total Patients Enrolled
1 Trials studying Prostate Cancer

Frequently Asked Questions

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

Is this trial open to minors or only adults?

"The admission guidelines of this clinical trial stipulate that participants must be 18 years old or older, and no more than 120."

Answered by AI

What are the objectives of this clinical experiment?

"This 18-month trial will assess the prevalence of Late Severe Gastrointestinal Toxicity (for Phase 2 Only). Secondary objectives include analyzing Gastrointestinal and Non-Genitourinary Toxicities using the National Cancer Institute Common Toxicity Criteria for Adverse Events, as well as measuring overall survival from date of accession to date of death."

Answered by AI

Are there any sites in North America administering this experiment?

"This research is accepting patients from the Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, as well as other centres such as the University of Minnesota Cancer Centre and UC Health Sciences Centre. Additionally, there are 5 more locations that have been added to this clinical trial."

Answered by AI

Does my profile meet the criteria for participating in this research project?

"This trial is searching for 94 individuals aged between 18 and 120 with a diagnosis of prostate cancer. Eligible participants must meet the following criteria: T2a or T2b stage, histologically confirmed adenocarcinoma of the prostate, no direct evidence of metastases, Gleason score ≤ 7, PSA ≤ 20 ng/mL (if Gleason 2-6) or 15 ng/mL (if Gleason 7), calculated risk of pelvic lymph node involvement <20%, and an ultrasound estimated volume of the prostate gland not exceeding 60 g."

Answered by AI

Is recruitment for this experimental protocol still open?

"The details on clinicaltrials.gov reveal that this research project is not currently enrolling patients. It was originally posted in July 2006 and last updated in March 2022, making it inactive compared to the other 1,321 medical studies actively recruiting participants at present."

Answered by AI
~5 spots leftby Mar 2025