Clinical trial NCT01434290: Radiation Therapy in Treating Patients With Prostate Cancer
Official title: A Randomized Phase II Trial of Hypofractionated Radiotherapy for Favorable Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Psychosocial Effects of Cancer and Its Treatment
Radiation Toxicity
Sexual Dysfunction
Keywords: radiation toxicity
sexual dysfunction
psychosocial effects of cancer and its treatment
adenocarcinoma of the prostate
stage I prostate cancer
stage IIA prostate cancer
Lead sponsor: Radiation Therapy Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: NRG Oncology
First posted: 2011-09-14
Enrollment: 255
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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

Primary outcomes:
measure: Percentage of Patients With Reduction From Baseline to the One-year EPIC Bowel Domain Score That Exceeds 5 Points
timeFrame: Baseline and one year from the end of protocol treatment
measure: The Percentage of Patients With Reduction From Baseline to One-year EPIC Urinary Domain Score That Exceeds 2 Points
timeFrame: Baseline and one year from the end of protocol treatment
Secondary outcomes:
measure: Acute and Late Gastrointestinal (GI) and Genitourinary (GU) Toxicity for Each Arm
timeFrame: Start of protocol treatment to one year from the end of protocol treatment
measure: Rate of PSA Failure
timeFrame: Registration to five years
measure: Rate of Disease-free Survival (DFS)
timeFrame: Registration to 5 years
measure: Mean Quality Adjusted Life Years at 5 Years
timeFrame: Registration to 5 years from the end of protocol treatment
measure: Change From Baseline in EPIC Bowel and Urinary HRQOL as Continuous Variables at One Year
timeFrame: Baseline and one year from the end of protocol treatment
measure: The Percentage of Patients With Reduction From Baseline at One Year in EPIC Sexual Domain Score That Exceeds 11 Points
timeFrame: Baseline one year from the end of protocol treatment
measure: The Percentage of Patients With Reduction From Baseline at One Year in EPIC Hormonal Domain Score That Exceeds 3 Points
timeFrame: Baseline and one year from the end of protocol treatment
measure: Change From Baseline in EQ-5D Scores
timeFrame: Baseline and one year from the end of protocol treatment
measure: Utilization of Sexual Medications/Devices Questionnaire Response Frequences
timeFrame: Baseline and one year from the end of protocol treatment
measure: Genetic Markers Associated With Normal Tissue Toxicities Resulting From Radiotherapy
timeFrame: Study entry to 5 years from the end of protocol treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Comprehensive Cancer Center
state: Alabama
city: Peoria
country: United States
facility: Arizona Center for Cancer Care - Peoria
state: Arizona
city: Phoenix
country: United States
facility: Arizona Oncology Services Foundation
state: Arizona
city: Oakland
country: United States
facility: Kaiser Permanente - Division of Research - Oakland
state: California
city: Rohnert Park
country: United States
facility: Rohnert Park Cancer Center
state: California
city: Roseville
country: United States
facility: Kaiser Permanente Medical Center - Roseville
state: California
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Santa Clara Medical Center
state: California
city: South San Francisco
country: United States
facility: Kaiser Permanente Medical Center - South San Francisco
state: California
city: Denver
country: United States
facility: Urology Center of Colorado
state: Colorado
city: Atlanta
country: United States
facility: Emory Crawford Long Hospital
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Honolulu
country: United States
facility: Queen's Cancer Institute at Queen's Medical Center
state: Hawaii
city: Boston
country: United States
facility: Boston University Cancer Research Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Saint Louis
country: United States
facility: Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
state: Missouri
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
state: North Carolina
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma University Cancer Institute
state: Oklahoma
city: Tulsa
country: United States
facility: Natalie Warren Bryant Cancer Center at St. Francis Hospital
state: Oklahoma
city: Abington
country: United States
facility: Rosenfeld Cancer Center at Abington Memorial Hospital
state: Pennsylvania
city: Bensalem
country: United States
facility: Rothman Specialty Hospital
state: Pennsylvania
city: Furlong
country: United States
facility: Fox Chase Cancer Center Buckingham
state: Pennsylvania
city: King Of Prussia
country: United States
facility: Academic Urology Prostate Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center - Philadelphia
state: Pennsylvania
city: Charleston
country: United States
facility: Hollings Cancer Center at Medical University of South Carolina
state: South Carolina
city: Spartanburg
country: United States
facility: Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
state: South Carolina
city: Charlottesville
country: United States
facility: University of Virginia Cancer Center
state: Virginia
city: Milwaukee
country: United States
facility: Columbia-Saint Mary's Cancer Care Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Cancer Center
state: Wisconsin
city: Edmonton
country: Canada
facility: Cross Cancer Institute at University of Alberta
state: Alberta
city: Hamilton
country: Canada
facility: Margaret and Charles Juravinski Cancer Centre
state: Ontario
city: Kitchener
country: Canada
facility: Grand River Regional Cancer Centre at Grand River Hospital
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Program at London Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: Hopital Notre-Dame du CHUM
state: Quebec
Study officials:
affiliation: Margaret and Charles Juravinski Cancer Centre
name: Himu R. Lukka, MD
role: PRINCIPAL_INVESTIGATOR
References: