Proton Therapy for High Risk Prostate Cancer
NCT01811810 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2019-04-23
Summary
The most common treatment for men with high risk prostate cancer is radiation therapy (XRT) followed by long term androgen deprivation therapy (ADT). Long-term AD is toxic, with substantial metabolic, physical, mental and sexual side-effects. In this study, the investigators propose a treatment strategy to optimize the control of high risk prostate cancer by using dose-escalated external beam radiation (proton therapy or IMRT) concurrent with docetaxel and adjuvant short-course AD. The investigators hypothesize that this approach will be superior to the current standard of care and obviate the need for long term AD. In this study, subjects will be randomized to either XRT with long term ADT or XRT and chemotherapy and short term ADT.
Conditions
Interventions
- RADIATION
-
Radiation therapy (XRT)
- OTHER
-
Androgen Deprivation Therapy (ADT)
- OTHER
-
Chemotherapy
Sponsors & Collaborators
-
Abramson Cancer Center at Penn Medicine
lead OTHER
Principal Investigators
-
John Christodouleas, MD · Abramson Cancer Center at Penn Medicine
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-03-31
- Primary Completion
- 2014-04-30
- Completion
- 2014-04-30
Countries
- United States
Study Locations
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