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Radiation
SUPR-SABR Treatment for Prostate Cancer (SUPR-SABR Trial)
N/A
Recruiting
Led By Harriet Eldredge-Hindy, MD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
SUPR-SABR Trial Summary
This trial tests a novel way of treating prostate cancer with radiation that could reduce side effects.
Who is the study for?
Men over 18 with untreated, localized prostate cancer (cT1-T2c, PSA<20 or <10 if on certain medications, Grade Group 1-3) and in good health can join. They must be able to undergo specific MRI scans for treatment planning and have a prostate volume less than 120 cc. Those with prior treatments for prostate cancer or other pelvic malignancies, distant metastases from prostate cancer, lymph node involvement by the disease, or severe urinary symptoms are excluded.Check my eligibility
What is being tested?
The trial is testing SUPR-SABR—a high-dose radiation therapy targeting the prostate while sparing surrounding areas like the urethra and rectum. It aims to see if this method reduces side effects compared to standard SABR in treating low- and intermediate-risk prostate cancer.See study design
What are the potential side effects?
Potential side effects may include genitourinary issues such as urinary frequency/urgency/incontinence and gastrointestinal problems like diarrhea or discomfort due to targeted high-dose radiation near sensitive areas.
SUPR-SABR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
12 month Expanded Prostate Cancer Index Composite (EPIC) gastrointestinal score
12 month Expanded Prostate Cancer Index Composite (EPIC) genitourinary score
Secondary outcome measures
1 month genitourinary toxicity as assessed by the International Prostate Symptom Score (IPSS)
12 and 24 month erectile function as assessed by the Sexual Health Inventory for Men (SHIM) score.
24 month Expanded Prostate Cancer Index Composite (EPIC) gastrointestinal score
+4 moreSUPR-SABR Trial Design
1Treatment groups
Experimental Treatment
Group I: SUPR-SABR treatmentExperimental Treatment1 Intervention
The prescription dose of this study will be 40 Gy in 5 fractions assigned to PTV_4000 which permits sparing of the rectum, urethra and pudendal artery. There will be a secondary dose level of 36.25 Gy in 5 fractions. A minimum dose of 36.25 Gy will be given to the entire prostate PTV_3625. 36.25 Gy in five fractions is currently endorsed as a standard of care for localized prostate cancer by the National Comprehensive Cancer Network guidelines in prostate cancer. Escalating the therapeutic radiation dose above 36.25 Gy provides potential for improved biochemical control of prostate cancer and decrease in relapse free survival.
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Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,600 Total Patients Enrolled
18 Trials studying Prostate Cancer
743 Patients Enrolled for Prostate Cancer
Harriet Eldredge-Hindy, MDPrincipal InvestigatorMUSC Department of Radiation Oncology
1 Previous Clinical Trials
158 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had treatments like surgery, cryotherapy, or radiation for prostate cancer.I am a man aged 18 or older.I have had radiation therapy to my pelvic area before.My health does not allow for radiation therapy aimed at curing my condition.I have been cancer-free for at least 5 years from any invasive pelvic, lymphoma, or blood cancer.I have a confirmed ATM gene mutation.I can take care of myself and perform daily activities.I am in good health and can undergo treatment aimed at curing my prostate cancer.I am a female.My prostate cancer has spread to my lymph nodes.I have prostate cancer and haven't received any treatment for it yet.My prostate cancer has spread to distant parts of my body.My prostate is smaller than 120 cc.My prostate cancer is early stage, with low PSA levels, and not aggressive.I am currently using testosterone supplements.I can undergo pelvic radiotherapy and follow the SUPR-SABR regimen.I've had bone and soft tissue scans within the last 4 months due to my symptoms or risk level.I am willing and able to have an MRI of my prostate and pelvis for radiation therapy planning.I had a physical and rectal exam within the last 90 days.
Research Study Groups:
This trial has the following groups:- Group 1: SUPR-SABR treatment
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.
Is enrollment for this medical experiment still open?
"Affirmative. Information on clinicaltrials.gov reveals that this medical experiment, posted in May of 2023, is still recruiting patients for participation. This research requires 36 individuals to be recruited from 1 separate location."
Answered by AI
What is the scale of engagement with this research project?
"Affirmative. Clinicaltrials.gov has evidence that this clinical investigation, first published on May 12th 2023, is currently enrolling participants. Altogether 36 individuals must be recruited from one trial site."
Answered by AI
What are the goals of this research experiment?
"This medical trial's primary outcome of measurement is a 12-month Expanded Prostate cancer Index Composite (EPIC) gastrointestinal score. Secondary endpoints encompass Common Terminology Criteria for Adverse Events, version 5 grade 3 or higher adverse events from radiation therapy; 24 month biochemical failure rate expressed as a percentage; and the 24-month EPIC genitourinary score which measures severity of symptoms on a scale of 0 to 100, where lower scores indicate greater impact."
Answered by AI
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