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Radiation
Stereotactic Ablative Radiotherapy for Prostate Cancer
Phase 1
Waitlist Available
Led By Raquibul Hannan, MD
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
All patients must be willing and capable to provide informed consent to participate in the protocol
Histologic confirmation of diagnosis of adenocarcinoma of the prostate will be required by biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is being done to find the maximum amount of radiation that can be given to the prostate and pelvic areas without causing too much toxicity. They will also be using cone-beam computed tomography (CT) and high-speed graphics processing unit (GPU) to help plan and give the radiation treatment. Another goal is to find out if temporal enhanced ultrasound can help track the prostate lesion during radiation therapy.
Who is the study for?
Men over 18 with high-risk prostate cancer (Gleason score ≥8, PSA ≥20 ng/ml, or advanced stage) who can undergo MRI and are eligible for a rectal spacer. They must agree to use contraception during treatment and be able to give informed consent. Excluded are those with prior pelvic cancer treatments, certain heart conditions, active infections, recent TURP surgery, planned antineoplastic therapies, metastases evidence after staging studies, severe co-morbidities like AIDS or significant psychiatric illness.Check my eligibility
What is being tested?
The trial tests the highest safe radiation dose that can be given to the prostate and pelvis using Stereotactic Ablative Radiotherapy (SABR). It also assesses real-time planning safety with cone-beam CT scans and GPU systems for each treatment fraction. The study aims to determine if higher doses improve tumor control without compromising quality of life.See study design
What are the potential side effects?
Potential side effects include typical radiation therapy risks such as skin irritation at the treatment site, fatigue, urinary issues like increased frequency or discomfort during urination; bowel changes including diarrhea; erectile dysfunction; and possibly more serious complications related to high-dose exposure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing and able to agree to the study's procedures.
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My prostate cancer diagnosis was confirmed through a biopsy.
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I am a man over 18 years old.
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I can take care of myself and am up and about more than 50% of my waking hours.
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
maximum tolerated dose (MTD)
Secondary outcome measures
Adverse events
Health-related quality of life
Overall survival
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Stereotactic Ablative RadiotherapyExperimental Treatment1 Intervention
Stereotactic Ablative Radiotherapy (SABR)
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,739 Total Patients Enrolled
16 Trials studying Prostate Cancer
2,100 Patients Enrolled for Prostate Cancer
Raquibul Hannan, MDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center
1 Previous Clinical Trials
25 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had pelvic radiotherapy, chemotherapy, or surgery for prostate cancer.I have been cancer-free for at least 3 years, except for non-melanoma skin cancer.I have used hormonal therapy for less than 9 months before joining this study.I am not planning to receive any other cancer treatments while on this trial.My tests show no cancer spread to other parts of my body.I do not have inflammatory colitis, active lupus, scleroderma, or any active collagen vascular disease.I have not had a prostate surgery in the last year.My PSA level is 20 ng/ml or higher, or I haven't started hormone therapy for prostate cancer yet.My lymph nodes are not cancerous as confirmed by tests within the last 3 months.I can undergo an MRI of the pelvis/prostate for cancer staging.My doctor agrees I can have hormone therapy for prostate cancer.My doctor has approved me for a rectal spacer procedure.My prostate cancer is aggressive (Gleason score ≥ 8) or is advanced (stage T3+).I agree to use effective birth control or practice abstinence during the study.I am willing and able to agree to the study's procedures.I have had imaging tests like ultrasound, CT, or MRI for my pelvis/prostate.My prostate is not larger than 80 grams, even after hormone treatment.My prostate cancer diagnosis was confirmed through a biopsy.I am a man over 18 years old.I can take care of myself and am up and about more than 50% of my waking hours.
Research Study Groups:
This trial has the following groups:- Group 1: Stereotactic Ablative Radiotherapy
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.
Are there any remaining vacancies for this trial's participants?
"This experiment, which debuted on October 1st 2015 and was last edited on February 14th 2022, is not currently recruiting. However, there are 1321 other clinical trials that participants can still join."
Answered by AI
Has the U.S. Food and Drug Administration officially sanctioned Stereotactic Ablative Radiotherapy?
"The safety of Stereotactic Ablative Radiotherapy has been assessed to be a 1 by the Power team, denoting that there is limited clinical evidence available for efficacy and safety in this Phase 1 trial."
Answered by AI
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