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Radiation

Arm I (near margin-less ART) for Prostate Cancer

N/A
Waitlist Available
Led By Mark R. Waddle, M.D.
Research Sponsored by Mayo Clinic
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 2 and 5 years
Awards & highlights

Study Summary

"This trial is comparing two different radiation therapies for localized prostate cancer. One treatment involves fewer but higher doses of radiation given over a shorter period, while the other involves more treatments with lower doses given over a

Who is the study for?
This trial is for men with localized prostate cancer, meaning the cancer hasn't spread. Participants should be suitable for and have not yet received radiation therapy. Specific details about who can join or reasons someone might be excluded aren't provided.Check my eligibility
What is being tested?
The study compares two types of radiation therapy: near margin-less Adaptive Radiation Therapy (ART) given in fewer treatments versus standard Stereotactic Ablative Body Radiotherapy (SABR) over more sessions. It aims to see if ART affects quality of life less than SABR while still being effective.See study design
What are the potential side effects?
Radiation therapies like ART and SABR may cause side effects such as skin irritation, fatigue, urinary issues, bowel problems, and sexual dysfunction. The severity varies from person to person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 and 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment-related, patient-reported early quality of life (QOL) changes
Secondary outcome measures
Biochemical recurrence
Bladder filling
Change in International Index of Erectile Function (IIEF)
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (near margin-less ART)Experimental Treatment5 Interventions
Patients undergo near margin-less ART for 2 treatments at least 3 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo CBCT and may undergo CT and/or MRI on study.
Group II: Arm II (standard SABR)Active Control4 Interventions
Patients undergo standard SABR for 5 treatments at least 2 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Image-Guided Adaptive Radiation Therapy
2015
Completed Early Phase 1
~50
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Cone-Beam Computed Tomography
2017
N/A
~70
Computed Tomography
2017
Completed Phase 2
~2720

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,227 Previous Clinical Trials
3,771,524 Total Patients Enrolled
34 Trials studying Prostate Cancer
8,388 Patients Enrolled for Prostate Cancer
Mark R. Waddle, M.D.Principal InvestigatorMayo Clinic in Rochester

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are prospective participants able to enroll in this research study at the present time?

"The trial listed on clinicaltrials.gov, posted initially on March 15th, 2024 and most recently revised the same day, is currently not in active recruitment. However, there are a substantial number of 1292 other trials available for potential participants to consider at this time."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluating Changes in Quality of Life After Near Margin-less Adaptive Radiation Therapy Compared to Standard Stereotactic Ablative Body Radiotherapy in Localized Prostate Cancer
2024. "Evaluating Changes in Quality of Life After Near Margin-less Adaptive Radiation Therapy Compared to Standard Stereotactic Ablative Body Radiotherapy in Localized Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06325046.
~96 spots leftby Jun 2026
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