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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05946213
Other study ID # NRG-GU013
Secondary ID NCI-2023-04142NR
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 13, 2023
Est. completion date March 31, 2041

Study information

Verified date February 2024
Source NRG Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1209
Est. completion date March 31, 2041
Est. primary completion date March 31, 2036
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
External Beam Radiation Therapy
Undergo EBRT
Stereotactic Body Radiation Therapy
Undergo SBRT

Locations

Country Name City State
United States McFarland Clinic - Ames Ames Iowa
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States Langlade Hospital and Cancer Center Antigo Wisconsin
United States Kaiser Permanente-Deer Valley Medical Center Antioch California
United States Saint Joseph Mercy Brighton Brighton Michigan
United States Aultman Health Foundation Canton Ohio
United States Saint Joseph Mercy Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Christiana Care Health System-Concord Health Center Chadds Ford Pennsylvania
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States Northwestern University Chicago Illinois
United States Siteman Cancer Center at West County Hospital Creve Coeur Missouri
United States Decatur Memorial Hospital Decatur Illinois
United States Northwestern Medicine Cancer Center Kishwaukee DeKalb Illinois
United States Kaiser Permanente Dublin Dublin California
United States Saint Luke's Hospital of Duluth Duluth Minnesota
United States Crossroads Cancer Center Effingham Illinois
United States Kaiser Permanente-Fremont Fremont California
United States Fresno Cancer Center Fresno California
United States Kaiser Permanente-Fresno Fresno California
United States Northwestern Medicine Cancer Center Delnor Geneva Illinois
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States Jupiter Medical Center Jupiter Florida
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States Kaiser Permanente-Modesto Modesto California
United States Helen F Graham Cancer Center Newark Delaware
United States Medical Oncology Hematology Consultants PA Newark Delaware
United States Kaiser Permanente Oakland-Broadway Oakland California
United States Kaiser Permanente-Oakland Oakland California
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States Kaiser Permanente-Rancho Cordova Cancer Center Rancho Cordova California
United States Kaiser Permanente- Marshall Medical Offices Redwood City California
United States Ascension Saint Mary's Hospital Rhinelander Wisconsin
United States Kaiser Permanente-Richmond Richmond California
United States Rohnert Park Cancer Center Rohnert Park California
United States Kaiser Permanente-Roseville Roseville California
United States The Permanente Medical Group-Roseville Radiation Oncology Roseville California
United States Kaiser Permanente Downtown Commons Sacramento California
United States Kaiser Permanente-South Sacramento Sacramento California
United States South Sacramento Cancer Center Sacramento California
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Siteman Cancer Center at Christian Hospital Saint Louis Missouri
United States Siteman Cancer Center-South County Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri
United States Kaiser Permanente-San Francisco San Francisco California
United States Kaiser Permanente-Santa Teresa-San Jose San Jose California
United States Kaiser Permanente San Leandro San Leandro California
United States Kaiser San Rafael-Gallinas San Rafael California
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States Kaiser Permanente-Santa Rosa Santa Rosa California
United States Memorial Hospital East Shiloh Illinois
United States Kaiser Permanente Cancer Treatment Center South San Francisco California
United States Kaiser Permanente-South San Francisco South San Francisco California
United States Memorial Medical Center Springfield Illinois
United States Ascension Saint Michael's Hospital Stevens Point Wisconsin
United States Kaiser Permanente-Stockton Stockton California
United States Kaiser Permanente Medical Center-Vacaville Vacaville California
United States Westchester Medical Center Valhalla New York
United States Kaiser Permanente-Vallejo Vallejo California
United States Kaiser Permanente-Walnut Creek Walnut Creek California
United States Northwestern Medicine Cancer Center Warrenville Warrenville Illinois
United States Aspirus Regional Cancer Center Wausau Wisconsin
United States Reading Hospital West Reading Pennsylvania
United States Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
NRG Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Patient-reported outcomes The EPIC-26 sexual domain will be assessed as an exploratory endpoint. Each response is standardized to a 0 to 100 scale, with higher scores indicating better health-related quality of life. Up to 5 years
Primary Metastasis-Free Survival (MFS) Based on conventional imaging. MFS will be estimated using the Kaplan-Meier method (Kaplan 1958). A confidence interval approach will be used adjusting for stratification factors. If the one sided 95% upper confidence limit of HR < 1.35, then the null hypothesis of inferiority will be rejected. If the 95% upper confidence limit excludes HR=1.35, then the null hypothesis of inferiority will be rejected. Cox proportional hazards models will be used to obtain unadjusted and adjusted HRs and 95% confidence intervals for the treatment effects. From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years
Secondary Failure-Free Survival Will be estimated using the Kaplan-Meier method and treatment arms compared using the stratified log-rank test. Cox proportional hazards models will be used to determine hazard ratios and to assess the effects of stratification factors and other covariates of interest, such as age, race, antiandrogen therapy (ADT) adherence, T stage, Gleason score, and performance status on outcomes. From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years
Secondary Overall Survival Will be estimated using the Kaplan-Meier method and treatment arms compared using the stratified log-rank test. Cox proportional hazards models will be used to determine hazard ratios and to assess the effects of stratification factors and other covariates of interest, such as age, race, ADT adherence, T stage, Gleason score, and performance status on outcomes. From the date of randomization to the date of death or last known follow-up date, with patients alive at the last known follow-up time treated as censored, assessed up to 15 years
Secondary MFS Based on molecular imaging. Will be estimated using the Kaplan-Meier method and treatment arms compared using the stratified log-rank test. Cox proportional hazards models will be used to determine hazard ratios and to assess the effects of stratification factors and other covariates of interest, such as age, race, ADT adherence, T stage, Gleason score, and performance status on outcomes. From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years
Secondary Incidence of Adverse Events (AEs) AEs will be graded using National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5. Counts of all AEs by grade will be provided by treatment arm. Up to 15 years
Secondary Urinary Incontinence domain of the Expanded Prostate Cancer Index Composite (EPIC-26) Each response is standardized to a 0 to 100 scale, with higher scores indicating better health-related quality of life. Up to 5 years
Secondary Urinary Irritative/Obstructive domain of the Expanded Prostate Cancer Index Composite (EPIC-26) Each response is standardized to a 0 to 100 scale, with higher scores indicating better health-related quality of life. Up to 5 years
Secondary Bowel domain of the Expanded Prostate Cancer Index Composite (EPIC-26) Each response is standardized to a 0 to 100 scale, with higher scores indicating better health-related quality of life. Up to 5 years
Secondary Fatigue Measured by the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue. Raw scores range from 7 to 35 and are standardized. A higher score indicates more fatigue. Up to 5 years
Secondary Cost Measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-COST. Up to 1 year
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