xMedica

NCT05946213ClinicalTrials.gov

Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer

The Phase III 'High Five Trial' Five Fraction Radiation For High-Risk Prostate Cancer

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.
יצירת קשר עם המחקר

בקצרה

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…

שלב 3דרושים 1,209 משתתפים413 אתרים4 מדינות

קטגוריות

אונקולוגיה72%נפרולוגיה ואורולוגיה28%

רשום במרשם אחד

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2023-07-14; recorded start 2023-12-14
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Open label (no blinding)Masking is recorded as none (open label)
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 49 other studies in this databaseCounted from the lead sponsor named in the record (NRG Oncology)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 3 conditions.
  • Lead sponsor type recorded as: other.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding0/20

    Open-label

  • Control arm15/15

    Active-comparator control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type10/10

    Mortality / MACE endpoint (hard clinical outcome)

  • Multi-centre8/8

    Multi-centre: 413 sites

  • Data monitoring committee0/7

    No data monitoring committee stated

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 1,209 participants (target), run at 413 sites, across 4 countries.

How this score is built
  • Enrolment31/40

    1,209 participants (target)

  • Site count25/25

    413 sites

  • Country count7/15

    4 countries

  • Planned duration10/10

    Planned over about 150 months

  • Sponsor scale6/10

    NRG Oncology has led 49 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

תקציר

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.

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 failure-free survival between treatment arms. VI. To compare metastasis-free survival based on molecular imaging between treatment arms. VII. 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. III. To compare patient-reported treatment burden (assessed by COmprehensive Score for financial Toxicity (COST)) 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 in the absence of disease progression or unacceptable toxicity. Patients also undergo bone scan and/or computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET)/CT during screening and CT and/or MRI on study. Additionally, patients may optionally undergo blood and urine sample collection on study. ARM II: Patients undergo external beam radiation treatment (EBRT) for 20-45 treatments over 4 to 9 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo bone scan and/or CT, MRI, or PET/CT during screening and CT and/or MRI on study. Additionally, patients may optionally undergo blood and urine sample collection on study. Patients are followed up every 6 months for 5 years.

מצבים רפואיים

  • Prostate Adenocarcinoma
  • Stage III Prostate Cancer AJCC v8
  • Stage IVA Prostate Cancer AJCC v8

זכאות

מיןזכר
גילאים18 Years – ללא מקסימום
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

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) value \> 20 ng/mL prior to starting androgen deprivation therapy (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 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 * No prior ablative or focal therapy to the prostate (including, but not limited to, transrectal or transurethral high-intensity focused ultrasound \[HIFU\], laser ablation, cryotherapy, irreversible electroporation \[IRE\], and vascular-targeted photodynamic therapy) * 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; Please note: PSA prior to the start of any ADT will be used to define disease * No contraindication to prostate MRI (required for planning of radiotherapy in both arms) * Patients enrolled in NRG-GU009 must be enrolled in NRG-GU013 prior to radiation therapy treatment planning and start of radiation therapy

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

סוג המחקרהתערבותי
שלבשלב 3
הקצאהאקראי
מודל ההתערבותPARALLEL
מטרה ראשיתTREATMENT
הסתרהNONE (0)
גיוסדרושים 1,209 משתתפים

נותן חסות ושותפים

  • NRG Oncology נותן חסות

זרועות והתערבויות

  • Arm I (SBRT)EXPERIMENTAL

    Patients undergo SBRT for a total of 5 treatments over 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo bone scan and/or CT, MRI, or PET/CT during screening and CT and/or MRI on study. Additionally, patients may optionally undergo blood and urine sample collection on study.

  • Arm II (EBRT)ACTIVE_COMPARATOR

    Patients undergo EBRT for 20 to 45 treatments over 4 to 9 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo bone scan and/or CT, MRI, or PET/CT during screening and CT and/or MRI on study. Additionally, patients may optionally undergo blood and urine sample collection on study.

התערבויות

  • פרוצדורה Biospecimen Collection

    Undergo blood and urine sample collection

  • פרוצדורה Bone Scan

    Undergo bone scan

  • פרוצדורה Computed Tomography

    Undergo CT or PET/CT

  • קרינה External Beam Radiation Therapy

    Undergo EBRT

  • פרוצדורה Magnetic Resonance Imaging

    Undergo MRI

  • פרוצדורה Positron Emission Tomography

    Undergo PET/CT

  • אחר Quality-of-Life Assessment

    Ancillary studies

  • אחר Questionnaire Administration

    Ancillary studies

  • קרינה Stereotactic Body Radiation Therapy

    Undergo SBRT

מדדי תוצאה

  1. מדד תוצאה ראשוני

    Metastasis-free survival (MFS)

    Based on conventional imaging. Median MFS time comparing the curves.

    מסגרת זמן From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years

  2. מדד תוצאה משני

    Failure-free survival

    Median failure-free survival time comparing the curves.

    מסגרת זמן From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years

  3. מדד תוצאה משני

    Overall survival

    Median survival time comparing the curves.

    מסגרת זמן 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

  4. מדד תוצאה משני

    MFS

    Median MFS time comparing the curves.

    מסגרת זמן From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years

  5. מדד תוצאה משני

    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.

    מסגרת זמן Up to 15 years

  6. מדד תוצאה משני

    Urinary incontinence

    Proportion of patients with a decline, as measured by the urinary incontinence domain of the Expanded Prostate Cancer Index Composite (EPIC-26).

    מסגרת זמן Up to 5 years

  7. מדד תוצאה משני

    Urinary irritative/obstructive

    Proportion of patients with a decline, as measured by the urinary irritative/obstructive domain of the Expanded Prostate Cancer Index Composite (EPIC-26).

    מסגרת זמן Up to 5 years

  8. מדד תוצאה משני

    Bowel function

    Proportion of patients with a decline, as measured by the bowel domain of the Expanded Prostate Cancer Index Composite (EPIC-26).

    מסגרת זמן Up to 5 years

  9. מדד תוצאה משני

    Fatigue

    Proportion of patients with a decline, as measured by the Patient Reported Outcomes Measurement Information System-Fatigue.

    מסגרת זמן Up to 5 years

  10. מדד תוצאה אחר

    Patient-reported outcomes

    The EPIC-26 sexual domain will be assessed as an exploratory endpoint but following the analysis plan specified for the EPIC-26 urinary and bowel domains.

    מסגרת זמן Up to 5 years

  11. מדד תוצאה אחר

    Cost

    Measured by the Functional Assessment of Chronic Illness Therapy-COST.

    מסגרת זמן Up to 1 year

  12. מדד תוצאה אחר

    Estimate of treatment effect by sex

    Will estimate the primary outcome treatment effect and the corresponding 95% confidence intervals (CIs) by sex.

    מסגרת זמן Up to 15 years

  13. מדד תוצאה אחר

    Estimate of treatment effect by race

    Will estimate the primary outcome treatment effect and the corresponding 95% CIs by race.

    מסגרת זמן Up to 15 years

  14. מדד תוצאה אחר

    Estimate of treatment effect by ethnicity

    Will estimate the primary outcome treatment effect and the corresponding 95% CIs by ethnicity.

    מסגרת זמן Up to 15 years

תאריכים

תאריך התחלה14 בדצמבר 2023 (בפועל)
סיום ראשוני31 במרץ 2036 (משוער)
סיום31 במרץ 2041 (משוער)
פורסם לראשונה14 ביולי 2023 (בפועל)
עודכן לאחרונה10 בספטמבר 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהספטמבר 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

409 אתרים מגייסים

Canada

מתקןעירמדינה או אזורמצב
CHUM - Centre Hospitalier de l'Universite de MontrealMontrealQuebecמגייס
The Research Institute of the McGill University Health Centre (MUHC)MontrealQuebecמגייס
CIUSSSEMTL-Hopital Maisonneuve-RosemontMontrealQuebecמגייס
Ottawa Hospital and Cancer Center-General CampusOttawaOntarioמגייס
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)QuébecQuebecמגייס
Atlantic Health Sciences Corporation-Saint John Regional HospitalSaint JohnNew Brunswickמגייס
Centre Hospitalier Universitaire de Sherbrooke-FleurimontSherbrookeQuebecמגייס
Odette Cancer Centre- Sunnybrook Health Sciences CentreTorontoOntarioמגייס
University Health Network-Princess Margaret HospitalTorontoOntarioמגייס

Hong Kong

מתקןעירמדינה או אזורמצב
Pamela Youde Nethersole Eastern HospitalChai Wanמושהה

Switzerland

מתקןעירמדינה או אזורמצב
Kantonsspital AarauAarauמגייס

United States

מתקןעירמדינה או אזורמצב
Cleveland Clinic Akron GeneralAkronOhioמגייס
University of New Mexico Cancer CenterAlbuquerqueNew Mexicoמגייס
Alton Memorial HospitalAltonIllinoisמגייס
American Fork Hospital / Huntsman Intermountain Cancer CenterAmerican ForkUtahמגייס
McFarland Clinic - AmesAmesIowaמגייס
University of Michigan Rogel Cancer CenterAnn ArborMichiganמגייס
Trinity Health Saint Joseph Mercy Hospital Ann ArborAnn ArborMichiganמגייס
Langlade Hospital and Cancer CenterAntigoWisconsinמגייס
Kaiser Permanente-Deer Valley Medical CenterAntiochCaliforniaמגייס
Northwest Wisconsin Cancer CenterAshlandWisconsinמגייס
Duluth Clinic AshlandAshlandWisconsinמגייס
Emory Saint Joseph's HospitalAtlantaGeorgiaמגייס
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgiaמגייס
Emory Proton Therapy CenterAtlantaGeorgiaמגייס
Emory University Hospital MidtownAtlantaGeorgiaמגייס
Grady Health SystemAtlantaGeorgiaמגייס
Advocate Outpatient Center - AuroraAuroraIllinoisמגייס
UCHealth University of Colorado HospitalAuroraColoradoמגייס
Mount Sinai Comprehensive Cancer Center at AventuraAventuraFloridaמגייס
UH Seidman Cancer Center at UH Avon Health CenterAvonOhioמגייס
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMarylandמגייס
Veterans Administration Medical Center-BaltimoreBaltimoreMarylandמגייס
University of Maryland/Greenebaum Cancer CenterBaltimoreMarylandמגייס
Maryland Proton Treatment CenterBaltimoreMarylandמגייס
Advocate Good Shepherd HospitalBarringtonIllinoisמגייס
MaineHealth Coastal Cancer Treatment CenterBathMaineמגייס
Mary Bird Perkins Cancer CenterBaton RougeLouisianaמגייס
Bay Pines VA Healthcare SystemBay PinesFloridaמגייס
Northwell Health Imbert Cancer CenterBay ShoreNew Yorkמגייס
UHHS-Chagrin Highlands Medical CenterBeachwoodOhioמגייס
UPMC-Heritage Valley Health System BeaverBeaverPennsylvaniaמגייס
UM Upper Chesapeake Medical CenterBel AirMarylandמגייס
Nebraska Medicine-BellevueBellevueNebraskaמגייס
PeaceHealth Saint Joseph Medical CenterBellinghamWashingtonמגייס
Sanford Joe Lueken Cancer CenterBemidjiMinnesotaמגייס
Saint Charles Health SystemBendOregonמגייס
Central Vermont Medical Center/National Life Cancer TreatmentBerlin CornersVermontמגייס
Tower Cancer Research FoundationBeverly HillsCaliforniaמגייס
Billings Clinic Cancer CenterBillingsMontanaמגייס

363 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

לא נרשמו שינויים מאז שקלטנו רשומה זו לראשונה.

שינוי נרשם בכל פעם שנותן החסות מעדכן את רשומת המרשם. מצב, תאריכים, גיוס ואתרים מופיעים כאן ככל שהם משתנים.

מרשם: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05946213