NCT01045226

Proton Radiation Therapy in Treating Patients With Prostate Cancer

A Phase II Trial of Proton Radiation Therapy of Using Standard Fractionation for Low-and Low-Intermediate Risk Adenocarcinoma of the Prostate

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This clinical trial is studying how well proton radiation therapy works in treating patients with prostate cancer.

Detailed description

Detailed Description PRIMARY OBJECTIVES: I. Feasibility of proton radiation therapy (RT) using standard fractionation. SECONDARY OBJECTIVES: I. To determine freedom from failure (FFF) (vs. biochemical/clinical progression-free survival) with standard fractionation. II. To determine the incidence of grade 2 or greater GU and GI toxicity with this regimen at 6 months, 2 years and 3 years. III. To assess quality of life issues following completion of radiation therapy at 6 months and at 2 years. IV. To assess incidence of impotence after the use of proton therapy at 3 years. V. To determine freedom from biochemical failure (BF) at 5 years. VI. To determine clinical failure: local and/or distant at 5 years. VII. To determine salvage androgen deprivation (SAD) use at 5 years. VIII. To determine progression free survival: using clinical, biochemical and SAD as events at 5 years. IX. To determine overall survival at 5 years. X. To determine disease-specific survival at 5 years. XI. Estimate prostate and normal structures movement during RT with the use of scans. XII. Correlate pathologic and radiologic findings with outcomes at 5 years. XIII. Correlate PSA and free PSA levels with outcomes at 5 years. XIV. Correlate testosterone levels and variation with proton therapy and outcomes at 5 years. XV. Develop a quality assurance process for proton prostate therapy. OUTLINE: Patients undergo proton radiotherapy once daily 5 days a week for approximately 9 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 3 months, every 6 months for 5 years, and then annually thereafter.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Proton Beam Radiation Therapy	Proton Beam Radiation Therapy
OTHER	Quality-of-Life assessment	Quality of Life Assessment
OTHER	Questionnaire Administration	Questionnaire Administration

Timeline

• Start date: 2009-08-01
• Primary completion: 2020-12-01
• Completion: 2022-03-17
• First posted: 2010-01-08
• Last updated: 2023-02-01

Locations

1 site across 1 country: United States