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

University of Florida1 site in 1 country77 target enrollmentDecember 2009

ConditionsProstate Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: University of Florida
Enrollment: 77
Locations: 1
Primary Endpoint: Acute Grade 3 or Higher Treatment-related Toxicity Rate.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2009

End Date

April 11, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

University of Florida

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Acute Grade 3 or Higher Treatment-related Toxicity Rate.

Time Frame: 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 Outcomes

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)