Docetaxel, Androgen Deprivation and Proton Therapy for High Risk Prostate Cancer
Not Applicable
Completed
- Conditions
- Prostate Cancer
- Registration Number
- NCT01040624
- Lead Sponsor
- University of Florida
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 77
Inclusion Criteria
* Adenocarcinoma of the prostate.
Exclusion Criteria
- Previous prostate cancer treatment such as chemotherapy and/or pelvic radiation.
- Active inflammatory bowel disease (diverticulitis, Crohn's disease or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed.)
- History of hip replacement.
- Prior intrapelvic surgery. This includes the following:
- Transrectal or rectal surgery other than polypectomy or hemorrhoid removal or banding
- Transabdominal pelvic surgery
- Bladder surgery
- Prior myocardial infarction (MI) or congestive heart failure (CHF).
- Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Acute Grade 3 or Higher Treatment-related Toxicity Rate. 6 months after the completion of radiation therapy Number of participants that experienced acute grade 3 or higher, treatment-related toxicity based on CTCAE version 3.0 criteria.
- Secondary Outcome Measures
Name Time Method Collect and Analyze Quality of Life, Treatment-related Late Morbidity, Disease Control, and Survival Outcome Parameters. After radiation: every 6 months for 3 years, then annually for 20 years Collect and Analyze Treatment, Biologic and Diagnostic Information That May Impact Quality of Life, Disease Control, Morbidity and/or Survival Outcomes. After radiation: every 6 months for 3 years, then annually for 20 years
Trial Locations
- Locations (1)
University of Florida Proton Therapy Institute
🇺🇸Jacksonville, Florida, United States
University of Florida Proton Therapy Institute🇺🇸Jacksonville, Florida, United States