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Radiation
Adaptive Radiotherapy + Hormone Therapy for Prostate Cancer
N/A
Recruiting
Led By Hiram Gay, M.D.
Research Sponsored by Washington University School of Medicine
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 at screening, end of radiotherapy (week 5), 3 months after start of radiotherapy, and every 3 months until month 24
Awards & highlights
Study Summary
This trial tests a new radiation therapy for prostate cancer, aiming to reduce side effects and be safe & feasible.
Who is the study for?
Men over 18 with high-risk or unfavorable intermediate-risk prostate cancer, who haven't had prior treatments like chemotherapy or radical prostatectomy in the last 3 years. They should have an ECOG performance status ≤1, no evidence of metastatic disease, and be able to start hormone therapy within 60 days of radiation treatment.Check my eligibility
What is being tested?
The trial is testing a new way to deliver radiation (Ethos Varian system) that adapts to the shape of the tumor daily, combined with hormone therapy. It aims to see if this method can target tumors more precisely while reducing side effects.See study design
What are the potential side effects?
Potential side effects include severe urinary and gastrointestinal issues such as pain when urinating, blood in urine, frequent urination, diarrhea, abdominal cramping, and rectal bleeding; however these are expected in less than 15% of patients.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at screening, end of radiotherapy (week 5), 3 months after start of radiotherapy, and every 3 months until month 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at screening, end of radiotherapy (week 5), 3 months after start of radiotherapy, and every 3 months until month 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of acute grade ≥3 GI and GU adverse events
Secondary outcome measures
Biochemical recurrence free-survival
Changes in global function as measured by EQ-5D-5L
Changes in patient-reported quality of life as measured by EPIC-26
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Adaptive stereotactic body radiotherapy (SBRT)Experimental Treatment3 Interventions
Treatment consists of adaptive dose-escalated stereotactic body radiotherapy (SBRT) to the pelvic nodes to 25 Gy in 5 weekly fractions with simultaneous integrated boosts (SIB) to the prostate and proximal seminal vesicles to 36.25 Gy in 5 fractions (full seminal vesicles if involved), to the prostate to 40 Gy in 5 fractions, and to the involved MR-detected nodule(s) to up to 50 Gy in 5 fractions.
Androgen deprivation therapy (ADT) will be administered to study patients according to institutional standard. Unfavorable Intermediate-risk Disease: Patients should receive a minimum of 4 months of ADT. Patients can receive longer duration of ADT at the discretion of the treating physician. High-risk disease: Patients should receive a minimum of 1 year of ADT. Patients can receive up to 2 years of ADT at the discretion of the treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Androgen deprivation therapy
2021
Completed Phase 4
~260
Find a Location
Who is running the clinical trial?
Varian Medical SystemsIndustry Sponsor
59 Previous Clinical Trials
3,754 Total Patients Enrolled
3 Trials studying Prostate Cancer
386 Patients Enrolled for Prostate Cancer
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,730 Total Patients Enrolled
17 Trials studying Prostate Cancer
4,246 Patients Enrolled for Prostate Cancer
Hiram Gay, M.D.Principal InvestigatorWashington University School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have undergone major prostate cancer treatment.My scans show cancer has spread to my lymph nodes or other parts of my body.I haven't had chemotherapy in the last 3 years.My cancer has grown into nearby structures.I cannot have markers placed in my prostate for radiation treatment.My prostate MRI showed only PIRADS 3 lesions without a biopsy.I had a prostate surgery (TURP) within the last 3 months.My condition is classified as unfavorable intermediate-risk with specific risk factors.My prostate gland is larger than 90 cc.I do not have any severe illnesses that would prevent me from receiving radiation or hormone therapy.I am 18 years old or older.I have high-risk prostate cancer with specific characteristics and plan to undergo specific treatments.I have a history of inflammatory bowel disease.I have scleroderma or a moderately severe autoimmune disease.I cannot lie on a treatment couch for 30 minutes.I have received hormone therapy for cancer within the last 60 days.I have a history of HIV or chronic hepatitis B or C.My prostate cancer is confirmed high-risk or unfavorable intermediate-risk.I have or had an anal fissure or a history of abnormal connections between my bowel and bladder.I have not had any cancer except for non-melanoma skin cancer in the past 2 years.I am fully active and can carry on all my pre-disease activities without restriction.
Research Study Groups:
This trial has the following groups:- Group 1: Adaptive stereotactic body radiotherapy (SBRT)
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 recruitment still ongoing for this trial?
"Clinicaltrials.gov reports that this trial has no longer been actively seeking participants since its last update on November 16th 2022. First posted 31st December of the same year, it is now one among 1321 other studies still recruiting patients at present."
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