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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
No Placebo-Only Group
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Changes in global function as measured by EQ-5D-5L
Changes in patient-reported quality of life as measured by EPIC-26
Other study objectives
Biochemical recurrence free-survival
Failure-free survival
Metastasis-free survival
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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 once or twice 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
62 Previous Clinical Trials
3,727 Total Patients Enrolled
4 Trials studying Prostate Cancer
395 Patients Enrolled for Prostate Cancer
Washington University School of MedicineLead Sponsor
2,000 Previous Clinical Trials
2,344,285 Total Patients Enrolled
17 Trials studying Prostate Cancer
4,356 Patients Enrolled for Prostate Cancer
Hiram Gay, M.D.Principal InvestigatorWashington University School of Medicine
Amit Bhatt, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine
Brian Baumann, 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.