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Radiation Therapy
Hypofractionated Intensity Modulated Radiotherapy (HIMRT) for Prostate Cancer
Phase 3
Waitlist Available
Led By Deborah A. Kuban, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8.5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing two different types of radiation therapy for prostate cancer. One has more days at a lower dose, and one has fewer days at a higher dose. The safety of these treatments will be compared.
Eligible Conditions
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8.5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Conventional Radiotherapy (CIMRT) Versus Hypofractionated Radiotherapy (HIMRT)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Hypofractionated Intensity Modulated Radiotherapy (HIMRT)Experimental Treatment1 Intervention
A total dose of 72 Gy will be delivered in 30 fractions to the PTV.
Group II: Intensity Modulated Radiotherapy (IMRT)Active Control1 Intervention
A total dose of 75.6 Gy will be delivered in 42 fractions to the planning target volume (PTV).
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,063 Previous Clinical Trials
1,800,556 Total Patients Enrolled
87 Trials studying Prostate Cancer
28,403 Patients Enrolled for Prostate Cancer
Deborah A. Kuban, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
1,051 Total Patients Enrolled
1 Trials studying Prostate Cancer
1,051 Patients Enrolled for Prostate Cancer
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