Adaptive stereotactic body radiotherapy (SBRT) for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Washington University School of Medicine, Saint Louis, MOProstate CancerEthos Varian treatment system - Device
Eligibility
18+
Male
What conditions do you have?
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Study Summary

This trial tests a new radiation therapy for prostate cancer, aiming to reduce side effects and be safe & feasible.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 18 Secondary · Reporting Duration: At screening, end of radiotherapy (week 5), 3 months after start of radiotherapy, and every 3 months until month 24

Month 24
Changes in global function as measured by EQ-5D-5L
Changes in patient-reported quality of life as measured by EPIC-26
Month 60
Rate of late GI and GU adverse events
Rate of late grade ≥3 adverse events at least possibly related to radiotherapy
Week 5
Number of displacements of the targets
Day 90
Rate of acute <grade 3 GI and GU adverse events
Rate of acute grade ≥3 GI and GU adverse events
Rate of acute grade ≥3 adverse events at least possibly related to radiotherapy
Month 60
Biochemical recurrence free-survival
Failure-free survival
Metastasis-free survival
Overall survival
Prostate cancer-specific mortality
Week 5
Change in PTV coverage for the scheduled versus adapted plans
Change in dose to the critical organs for the scheduled versus adapted plans
Frequency of using the adapted plan versus scheduled plan
Percentage of MR-defined GTV receiving prescription dose (50 Gy) and >45 Gy
Time on the treatment table
Time to complete adaptive planning

Trial Safety

Safety Progress

1 of 3

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Trial Design

1 Treatment Group

Adaptive stereotactic body radiotherapy (SBRT)
1 of 1

Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: Adaptive stereotactic body radiotherapy (SBRT) · No Placebo Group · N/A

Adaptive stereotactic body radiotherapy (SBRT)Experimental Group · 3 Interventions: Ethos Varian treatment system, Adaptive stereotactic body radiotherapy, Androgen deprivation therapy · Intervention Types: Device, Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Androgen deprivation therapy
2015
Completed Phase 4
~240

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at screening, end of radiotherapy (week 5), 3 months after start of radiotherapy, and every 3 months until month 24

Who is running the clinical trial?

Varian Medical SystemsIndustry Sponsor
39 Previous Clinical Trials
2,960 Total Patients Enrolled
1 Trials studying Prostate Cancer
66 Patients Enrolled for Prostate Cancer
Washington University School of MedicineLead Sponsor
1,821 Previous Clinical Trials
2,280,983 Total Patients Enrolled
17 Trials studying Prostate Cancer
7,508 Patients Enrolled for Prostate Cancer
Brian Baumann, M.D.Principal InvestigatorWashington University School of Medicine

Eligibility Criteria

Age 18+ · Male Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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