Prostate Cancer Clinical Trial
Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer
Summary
This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.
Full Description
PRIMARY OBJECTIVE:
I. To compare metastasis-free survival, determined using conventional imaging, between men with high-risk prostate cancer randomized to ultrahypofractionation (stereotactic body radiation therapy [SBRT]) to those randomized to moderate hypofractionation and conventional fractionation.
SECONDARY OBJECTIVES:
I. To compare physician-reported toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5 between treatment arms.
II. To determine if ultrahypofractionation is non-inferior to moderate hypofractionation and conventional fractionation with respect to patient-reported urinary function (assessed by Expanded Prostate Cancer Index Composite [EPIC]-26 urinary domains).
III. To determine if ultrahypofractionation is non-inferior to moderate hypofractionation and conventional fractionation with respect to patient-reported bowel function (assessed by EPIC-26 bowel domain).
IV. To compare patient-reported fatigue (assessed by Patient Reported Outcomes Measurement Information System [PROMIS]-Fatigue) between treatment arms.
V. To compare patient-reported treatment burden (assessed by COmprehensive Score for financial Toxicity [COST]) between treatment arms.
VI. To compare failure-free survival between treatment arms. VII. To compare metastasis-free survival based on molecular imaging between treatment arms.
VIII. To compare overall survival between treatment arms.
EXPLORATORY OBJECTIVES:
I. To compare patient-reported sexual function (assessed by EPIC-26 sexual domain) between treatment arms.
II. To compare patient-reported quality of life (assessed by European Quality of Life Five Dimension Five Level Scale Questionnaire [EQ-5D-5L]) between treatment arms.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo SBRT for a total of 5 treatments over 2 weeks.
ARM II: Patients undergo external beam radiation treatment (EBRT) for 20-45 treatments over 4 to 9 weeks.
Patients are followed up every 6 months for 5 years.
Eligibility Criteria
Inclusion Criteria:
Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer
High-risk disease defined as having at least one or more of the following:
cT3a-T3b by digital exam or imaging (American Joint Committee on Cancer [AJCC] 8th edition [Ed.]) Note: cT4 by imaging or on digital rectal exam is not allowed
The patient's prostate specific antigen (PSA) > 20 ng/mL prior to starting ADT Note: Patients taking a 5-alpha reductase inhibitor (ex finasteride or dutasteride) are eligible. The baseline PSA value should be doubled for PSAs taken while on 5-alpha reductase inhibitors
Gleason Score of 8-10
Pelvic node positive by conventional imaging with a short axis of at least 1.0 cm
Prostate gland volume less than 100 cc prior to initiation of ADT as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities including MRI or computed tomography (CT) scan
No definitive clinical or radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI); Negative prostate-specific membrane antigen (PSMA) positron emission tomography (PET) is an acceptable substitute
Age >= 18
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
No prior radical prostatectomy
Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both luteinizing hormone releasing hormone [LHRH] agonist and oral anti-androgen) is =< 185 days prior to registration
Patients enrolled in NRG-GU009 must be enrolled in NRG-GU013 prior to radiation therapy treatment planning and start of radiation therapy
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 61 Locations for this study
Antioch California, 94531, United States More Info
Principal Investigator
Dublin California, 94568, United States More Info
Principal Investigator
Fremont California, 94538, United States More Info
Principal Investigator
Fresno California, 93720, United States More Info
Principal Investigator
Fresno California, 93720, United States More Info
Principal Investigator
Modesto California, 95356, United States More Info
Principal Investigator
Oakland California, 94611, United States More Info
Principal Investigator
Oakland California, 94611, United States More Info
Principal Investigator
Orange California, 92868, United States More Info
Principal Investigator
Rancho Cordova California, 95670, United States More Info
Principal Investigator
Redwood City California, 94063, United States More Info
Principal Investigator
Richmond California, 94801, United States More Info
Principal Investigator
Rohnert Park California, 94928, United States More Info
Principal Investigator
Roseville California, 95661, United States More Info
Principal Investigator
Roseville California, 95678, United States More Info
Principal Investigator
Sacramento California, 95814, United States More Info
Principal Investigator
Sacramento California, 95823, United States More Info
Principal Investigator
Sacramento California, 95823, United States More Info
Principal Investigator
San Francisco California, 94115, United States More Info
Principal Investigator
San Jose California, 95119, United States More Info
Principal Investigator
San Leandro California, 94577, United States More Info
Principal Investigator
San Rafael California, 94903, United States More Info
Principal Investigator
Santa Clara California, 95051, United States More Info
Principal Investigator
Santa Rosa California, 95403, United States More Info
Principal Investigator
South San Francisco California, 94080, United States More Info
Principal Investigator
South San Francisco California, 94080, United States More Info
Principal Investigator
Stockton California, 95210, United States More Info
Principal Investigator
Vacaville California, 95688, United States More Info
Principal Investigator
Vallejo California, 94589, United States More Info
Principal Investigator
Walnut Creek California, 94596, United States More Info
Principal Investigator
Newark Delaware, 19713, United States More Info
Principal Investigator
Newark Delaware, 19713, United States More Info
Principal Investigator
Jupiter Florida, 33458, United States More Info
Principal Investigator
Chicago Illinois, 60611, United States More Info
Principal Investigator
Decatur Illinois, 62526, United States More Info
Principal Investigator
DeKalb Illinois, 60115, United States More Info
Principal Investigator
Effingham Illinois, 62401, United States More Info
Principal Investigator
Geneva Illinois, 60134, United States More Info
Principal Investigator
Shiloh Illinois, 62269, United States More Info
Principal Investigator
Springfield Illinois, 62781, United States More Info
Principal Investigator
Warrenville Illinois, 60555, United States More Info
Principal Investigator
Ames Iowa, 50010, United States More Info
Principal Investigator
Ann Arbor Michigan, 48106, United States More Info
Principal Investigator
Brighton Michigan, 48114, United States More Info
Principal Investigator
Canton Michigan, 48188, United States More Info
Principal Investigator
Chelsea Michigan, 48118, United States More Info
Principal Investigator
Livonia Michigan, 48154, United States More Info
Principal Investigator
Duluth Minnesota, 55805, United States More Info
Principal Investigator
Cape Girardeau Missouri, 63703, United States More Info
Principal Investigator
Creve Coeur Missouri, 63141, United States More Info
Principal Investigator
Saint Louis Missouri, 63110, United States More Info
Principal Investigator
Saint Louis Missouri, 63129, United States More Info
Principal Investigator
Saint Louis Missouri, 63131, United States More Info
Principal Investigator
Saint Louis Missouri, 63136, United States More Info
Principal Investigator
Saint Peters Missouri, 63376, United States More Info
Principal Investigator
Great Falls Montana, 59405, United States More Info
Principal Investigator
Valhalla New York, 10595, United States More Info
Principal Investigator
Canton Ohio, 44710, United States More Info
Principal Investigator
Oklahoma City Oklahoma, 73104, United States More Info
Principal Investigator
Chadds Ford Pennsylvania, 19317, United States More Info
Principal Investigator
West Reading Pennsylvania, 19611, United States More Info
Principal Investigator
Antigo Wisconsin, 54409, United States More Info
Principal Investigator
Rhinelander Wisconsin, 54501, United States More Info
Principal Investigator
Stevens Point Wisconsin, 54481, United States More Info
Principal Investigator
Wausau Wisconsin, 54401, United States More Info
Principal Investigator
Wisconsin Rapids Wisconsin, 54494, United States More Info
Principal Investigator
How clear is this clinincal trial information?