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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01434290
Other study ID # RTOG 0938
Secondary ID CDR0000703580NCI
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2011
Est. completion date May 20, 2022

Study information

Verified date May 2022
Source Radiation Therapy Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 255
Est. completion date May 20, 2022
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
36.25 Gy IMRT
36.25 Gy in 5 fractions of 7.5 Gy twice a week over 15-17 days. A minimum of 72 hours and a maximum of 96 hours will separate each treatment. IMRT or similar techniques that use inverse treatment planning or protons are required.
51.6 Gy IMRT
51.6 Gy in 12 fractions of 4.3 Gy 5 days a week over 16-18 days. IMRT or similar techniques that use inverse treatment planning or protons are required.

Locations

Country Name City State
Canada Cross Cancer Institute at University of Alberta Edmonton Alberta
Canada Margaret and Charles Juravinski Cancer Centre Hamilton Ontario
Canada Grand River Regional Cancer Centre at Grand River Hospital Kitchener Ontario
Canada London Regional Cancer Program at London Health Sciences Centre London Ontario
Canada Hopital Notre-Dame du CHUM Montreal Quebec
United States Rosenfeld Cancer Center at Abington Memorial Hospital Abington Pennsylvania
United States Emory Crawford Long Hospital Atlanta Georgia
United States Winship Cancer Institute of Emory University Atlanta Georgia
United States Rothman Specialty Hospital Bensalem Pennsylvania
United States UAB Comprehensive Cancer Center Birmingham Alabama
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Boston University Cancer Research Center Boston Massachusetts
United States Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill North Carolina
United States Hollings Cancer Center at Medical University of South Carolina Charleston South Carolina
United States University of Virginia Cancer Center Charlottesville Virginia
United States Case Comprehensive Cancer Center Cleveland Ohio
United States Urology Center of Colorado Denver Colorado
United States Fox Chase Cancer Center Buckingham Furlong Pennsylvania
United States Queen's Cancer Institute at Queen's Medical Center Honolulu Hawaii
United States Academic Urology Prostate Center King Of Prussia Pennsylvania
United States Columbia-Saint Mary's Cancer Care Center Milwaukee Wisconsin
United States Medical College of Wisconsin Cancer Center Milwaukee Wisconsin
United States Kaiser Permanente - Division of Research - Oakland Oakland California
United States Oklahoma University Cancer Institute Oklahoma City Oklahoma
United States Arizona Center for Cancer Care - Peoria Peoria Arizona
United States Fox Chase Cancer Center - Philadelphia Philadelphia Pennsylvania
United States Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania
United States Arizona Oncology Services Foundation Phoenix Arizona
United States Mayo Clinic Cancer Center Rochester Minnesota
United States Rohnert Park Cancer Center Rohnert Park California
United States Kaiser Permanente Medical Center - Roseville Roseville California
United States Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Saint Louis Missouri
United States UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California
United States Kaiser Permanente Santa Clara Medical Center Santa Clara California
United States Kaiser Permanente Medical Center - South San Francisco South San Francisco California
United States Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg South Carolina
United States Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa Oklahoma

Sponsors (3)

Lead Sponsor Collaborator
Radiation Therapy Oncology Group National Cancer Institute (NCI), NRG Oncology

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Patients With Reduction From Baseline to the One-year EPIC Bowel Domain Score That Exceeds 5 Points The co-primary endpoint is the percentage of patients with a reduction in the Expanded Prostate Cancer Index Composite (EPIC) bowel domain score from baseline to 1 year that exceeds 5 points (baseline - one year > 5). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other. Baseline and one year from the end of protocol treatment
Primary The Percentage of Patients With Reduction From Baseline to One-year EPIC Urinary Domain Score That Exceeds 2 Points The co-primary endpoint is the proportion of patients with a reduction in the Expanded Prostate Cancer Index Composite (EPIC) urinary domain score from baseline to 1 year that exceeds 2 points (baseline - one year > 2). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other. Baseline and one year from the end of protocol treatment
Secondary Acute and Late Gastrointestinal (GI) and Genitourinary (GU) Toxicity for Each Arm Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. An acute adverse event is defined as the first occurrence of worst severity of the adverse event =30 days after the completion of radiation therapy (RT). The high dose RT arm of Radiation Therapy Oncology Group (RTOG) study RTOG-0126 (NCT00033631) reported 1% of patients experienced grade 3+ GI/GU acute toxicity with no patient experiencing a grade 4 or 5 toxicity. If the lower confidence interval is >1%, then that arm will be further investigated for acceptability. A late adverse event is defined as the first occurrence of worst severity of adverse event >30 days after RT completion. Arms are not compared to each other. Start of protocol treatment to one year from the end of protocol treatment
Secondary Rate of PSA Failure Failure occurs when the PSA is first noted to be 2 ng/mL or more than the current nadir value (PSA > current nadir + 2) post RT completion. Time to PSA failure is defined as time from registration to the date of PSA failure, last known follow-up (censored), or death without PSA failure (competing risk). Rate of PSA failure is estimated by the cumulative incidence method. The protocol specified that one-, two-, and five-year rates would be reported. Arms are not compared to each other. Registration to five years
Secondary Rate of Disease-free Survival (DFS) Disease-free survival duration is time from the date of randomization to the date of documentation of disease progression or until the date of death from any cause (censored). DFS is estimated by the Kaplan-Meier method. The protocol specified that one-, two-, and five-year rates would be reported. Arms are not compared to each other. Registration to 5 years
Secondary Mean Quality Adjusted Life Years at 5 Years Quality-adjusted survival time combines disease-free survival time and quality of life as measured by the EuroQol 5-dimensional (EQ-5D) index score. It is calculated for each patient as the weighted sum of different time episodes and added up to total quality-adjusted life years . The EQ-5D measures health-related quality of life and consists of two parts, a general health visual analog scale and 5 general health questions. The latter questions are transformed into a single index score ranging from 0 (worst health state) to 1 (best health state). Arms are not compared to each other. Registration to 5 years from the end of protocol treatment
Secondary Change From Baseline in EPIC Bowel and Urinary HRQOL as Continuous Variables at One Year The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life and a positive change from baseline indicating improvement over time. For this endpoint, in each domain, the actual change score calculated as timepoint score - baseline score will be used as the statistic. Baseline and one year from the end of protocol treatment
Secondary The Percentage of Patients With Reduction From Baseline at One Year in EPIC Sexual Domain Score That Exceeds 11 Points The percentage of patients with a reduction in the EPIC sexual domain score from baseline that exceeds 11 points (baseline - one year > 11). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other. Baseline one year from the end of protocol treatment
Secondary The Percentage of Patients With Reduction From Baseline at One Year in EPIC Hormonal Domain Score That Exceeds 3 Points The percentage of patients with a reduction in the EPIC hormonal domain score from baseline that exceeds 3 points (baseline - one year > 3). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other. Baseline and one year from the end of protocol treatment
Secondary Change From Baseline in EQ-5D Scores The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). Change from baseline is calculated as score at the timepoint of interested - baseline score. One, 2, and 5 years will be entered when they are available. Arms are not compared. Baseline and one year from the end of protocol treatment
Secondary Utilization of Sexual Medications/Devices Questionnaire Response Frequences The Utilization of Sexual Medications/Devices questionaire is designed to assess the use of erectile aids among patients treated for prostate cancer. This instrument is used to complement the sexual symptom domain in the EPIC. The number of subjects responding "Yes" to the following questions are reported: "Do you have a penile prosthesis", "Have you used an medications or devices to aid or improve erections?". Arms are not compared to each other. One, 2, and 5 years will be entered when they are available. Baseline and one year from the end of protocol treatment
Secondary Genetic Markers Associated With Normal Tissue Toxicities Resulting From Radiotherapy Study entry to 5 years from the end of protocol treatment
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