Clinical Trial: Radiation Therapy in Treating Patients With Prostate Cancer

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Randomized Phase II Trial of Hypofractionated Radiotherapy for Favorable Risk Prostate Cancer

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Given radiation therapy in different ways may kill more tumor cells.

PURPOSE: This randomized phase II trial studies radiation therapy to see how well it works in treating patients with prostate cancer.


Detailed Summary:

OBJECTIVES:

Primary

  • To demonstrate that 1-year health-related quality of life (HRQOL) for at least one hypofractionated arm is not significantly lower than baseline as measured by the Bowel and Urinary domains of the Expanded Prostate Cancer Index Composite (EPIC) instrument.

Secondary

  • To estimate the degree of change in HRQOL in each arm for the Sexual and Hormonal EPIC domains and the Utilization of Sexual Medications/Devices from baseline to 1 year, 2 years, and 5 years.
  • To estimate the degree of change in global HRQOL in each arm as measured by the Euro Quality of Life, 5 dimensions (EQ-5D) from baseline to 1 year, 2 years, and 5 years.
  • To estimate the rate of acute and late gastrointestinal (GI) and genitourinary (GU) toxicity for each arm at 1, 2, and 5 years.
  • To estimate prostate-specific antigen (PSA) failure in each arm at 1, 2, and 5 years.
  • To estimate disease-free survival (DFS) in each arm at 1, 2, and 5 years.
  • To estimate Quality Adjusted Life Years for each arm at 1, 2, and 5 years using the EQ-5D and DFS.
  • To identify genetic markers associated with normal tissue toxicities resulting from radiotherapy.
  • To collect tumor tissue for biomarker studies.
  • To estimate EPIC bowel and urinary HRQOL as continuous variables.

OUTLINE: This is a multicenter study. Patients are stratified according to treatment techniques/mac
Sponsor: Radiation Therapy Oncology Group

Current Primary Outcome:

  • The proportion of patients with change from baseline to the 1-year EPIC bowel-domain score that exceeds 5 points [ Time Frame: Pre-treatment to 1 year from the end of protocol treatment ]
  • The proportion of patients change from baseline to 1 year EPIC urinary-domain score that exceeds 2 points [ Time Frame: Pre-treatment to 1 year from the end of protocol treatment ]


Original Primary Outcome:

  • The proportion of patients with change from baseline to the 1-year EPIC bowel-domain score that exceeds 5 points
  • The proportion of patients change from baseline to 1 year EPIC urinary-domain score that exceeds 2 points


Current Secondary Outcome:

  • Acute and late GI and GU toxicity for each arm at 1, 2, and 5 years [ Time Frame: Study entry to 5 years from the end of protocol treatment ]
  • PSA failure at 1, 2, and 5 years [ Time Frame: Date of registration to 5 years from the end of protocol treatment ]
  • Disease-free survival at 1, 2, and 5 years [ Time Frame: Date of registration to 5 years from the end of protocol treatment ]
  • Quality Adjusted Life Years at 1, 2, and 5 years using the EQ-5D and DFS [ Time Frame: Pre-treatment to 5 years from the end of protocol treatment ]
  • Genetic markers associated with normal tissue toxicities resulting from radiotherapy [ Time Frame: Study entry to 5 years from the end of protocol treatment ]
  • Estimation of EPIC bowel and urinary HRQOL as continuous variables [ Time Frame: Study entry to 5 years from the end of protocol treatment ]


Original Secondary Outcome:

  • Acute and late GI and GU toxicity for each arm at 1, 2, and 5 years
  • PSA failure at 1, 2, and 5 years
  • Disease-free survival at 1, 2, and 5 years
  • Quality Adjusted Life Years at 1, 2, and 5 years using the EQ-5D and DFS
  • Genetic markers associated with normal tissue toxicities resulting from radiotherapy
  • Estimation of EPIC bowel and urinary HRQOL as continuous variables


Information By: Radiation Therapy Oncology Group

Dates:
Date Received: September 13, 2011
Date Started: September 2011
Date Completion:
Last Updated: November 14, 2015
Last Verified: November 2015