Docetaxel, Androgen Deprivation and Proton Therapy for High Risk Prostate Cancer
NCT01040624 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77
Last updated 2023-10-03
Summary
The purpose of this study is to see what effects, good and/or bad, proton based radiation combined with low dose chemotherapy and hormonal therapy, has on patients and their cancer.
Conditions
Interventions
- RADIATION
-
< 15% risk of + LN
Total of 54 Cobalt gray equivalent (CGE) over 30 treatments to prostate + seminal vesicles (SV), then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during radiation therapy (RT) followed by androgen deprivation therapy for 6 months.
- RADIATION
-
> 15% risk of + LN
Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.
Sponsors & Collaborators
-
University of Florida
lead OTHER
Principal Investigators
-
Nancy P Mendenhall, MD · University of Florida Proton Therapy Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-12-31
- Primary Completion
- 2015-01-31
- Completion
- 2022-04-11
Countries
- United States
Study Locations
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