Clinical trial NCT01040624: Docetaxel, Androgen Deprivation and Proton Therapy for High Risk Prostate Cancer
Official title: A Phase II Study of Proton-Based Radiation Therapy With Elective Pelvic Nodal Irradiation, Concomitant Docetaxel, and Adjuvant Androgen Deprivation for High-Risk Prostate Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer, Proton Radiation
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2009-12-29
Enrollment: 77
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Acute Grade 3 or Higher Treatment-related Toxicity Rate.
timeFrame: 6 months after the completion of radiation therapy
Secondary outcomes:
measure: Collect and Analyze Quality of Life, Treatment-related Late Morbidity, Disease Control, and Survival Outcome Parameters.
timeFrame: After radiation: every 6 months for 3 years, then annually for 20 years
measure: Collect and Analyze Treatment, Biologic and Diagnostic Information That May Impact Quality of Life, Disease Control, Morbidity and/or Survival Outcomes.
timeFrame: After radiation: every 6 months for 3 years, then annually for 20 years
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Proton Therapy Institute
state: Florida
Study officials:
affiliation: University of Florida Proton Therapy Institute
name: Nancy P Mendenhall, MD
role: PRINCIPAL_INVESTIGATOR
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