Radiation Therapy in Treating Patients With Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
NRG Oncology Foundation, Inc.
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT01434290
First received: September 13, 2011
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Psychosocial Effects of Cancer and Its Treatment
Radiation Toxicity
Sexual Dysfunction
Radiation: hypofractionated radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial of Hypofractionated Radiotherapy for Favorable Risk Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • PSA failure at 1, 2, and 5 years [ Time Frame: Date of registration to 5 years from the end of protocol treatment ] [ Designated as safety issue: No ]
  • Disease-free survival at 1, 2, and 5 years [ Time Frame: Date of registration to 5 years from the end of protocol treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Genetic markers associated with normal tissue toxicities resulting from radiotherapy [ Time Frame: Study entry to 5 years from the end of protocol treatment ] [ Designated as safety issue: No ]
  • Estimation of EPIC bowel and urinary HRQOL as continuous variables [ Time Frame: Study entry to 5 years from the end of protocol treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: September 2011
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients undergo intensity-modulated radiation therapy (IMRT) twice a week for approximately 2½ weeks (36.25 Gy total).
Radiation: hypofractionated radiation therapy
Given twice a week for 2½ weeks (36.25 fractions)
Experimental: Arm II
Patients undergo IMRT once a day, 5 days a week, for approximately 2½ weeks (51.6 Gy total).
Radiation: hypofractionated radiation therapy
Given twice a week for 2½ weeks (36.25 fractions)

Detailed Description:

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/machine (all linear accelerator-based treatment [excluding cyberknife] vs cyberknife vs protons). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo hypofractionated radiotherapy using intensity-modulated radiation therapy (IMRT), cyberknife, or protons twice a week for approximately 2½ weeks (36.25 Gy total).
  • Arm II: Patients undergo hypofractionated radiotherapy using IMRT, cyberknife, or protons once a day, 5 days a week, for approximately 2½ weeks (51.6 Gy total).

Patients may undergo blood and tumor tissue collection for correlative studies.

Patients may also complete the Utilization of Sexual Medications/Devices, the European Questionnaire-5D, and the Bowel and Urinary domains of the Expanded Prostate Cancer Index Composite (EPIC) questionnaires at baseline and at 1, 2, and 5 years after completion of radiation therapy.

After completion of study therapy, patients are followed-up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180 days of randomization

    • History/physical examination with digital rectal examination of the prostate within 60 days prior to registration
    • Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason scores 2-6 within 180 days of randomization
    • Clinical stage T1-2a (AJCC 7th edition) within 90 days of randomization
    • Prostate-specific antigen (PSA) < 10 ng/mL within 60 days prior to registration;

      • PSA should not be obtained within 10 days after prostate biopsy
  • No evidence of distant metastases
  • No regional lymph node involvement

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
  • No prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease-free for a minimum of 5 years (for example, carcinoma of the oral cavity is permissible; however, patients with prior history of bladder cancer are not allowed)
  • No severe, active co-morbidity, defined as follows:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
    • Transmural myocardial infarction within the last 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

      • Laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
    • Acquired Immune Deficiency Syndrome (AIDS) based upon current Center for Disease Control (CDC) definition

      • HIV testing is not required for entry into this protocol
      • Protocol-specific requirements may also exclude immuno-compromised patients

PRIOR CONCURRENT THERAPY:

  • No prior radical surgery (prostatectomy), cryosurgery, or high-intensity focused ultrasonography (HIFU) for prostate cancer
  • No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
  • No prior hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., goserelin, leuprolide) or LHRH antagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., diethylstilbestrol (DES)), or surgical castration (orchiectomy)
  • No finasteride within 30 days prior to registration

    • Prostate-specific antigen (PSA) should not be obtained prior to 30 days after stopping finasteride
  • No dutasteride within 90 days prior to registration

    • PSA should not be obtained prior to 90 days after stopping dutasteride
  • No prior or concurrent cytotoxic chemotherapy for prostate cancer
  • Patients on Coumadin or other blood-thinning agents are eligible for this study
  • No concurrent 3D-conformal radiation therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434290

  Show 37 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
NRG Oncology Foundation, Inc.
Investigators
Principal Investigator: Himu R. Lukka, MD Margaret and Charles Juravinski Cancer Centre
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01434290     History of Changes
Other Study ID Numbers: RTOG 0938, CDR0000703580, NCI-2011-03629
Study First Received: September 13, 2011
Last Updated: July 30, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
radiation toxicity
sexual dysfunction
psychosocial effects of cancer and its treatment
adenocarcinoma of the prostate
stage I prostate cancer
stage IIA prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Radiation Injuries
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on August 28, 2014