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

En recrutementAccepte des participants actuellement, selon la fiche du registre.

Contacter cette étude

En bref

Phase 31 209 participants recherchés413 sites4 pays

Catégories

Oncologie72%Néphrologie et urologie28%

Enregistré dans 1 registre

ClinicalTrials.govNCT05946213Ouvrir cette fiche sur ClinicalTrials.govSynchronisé il y a 2 semaines

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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.

Present: Registered before enrolment beganFirst posted 2023-07-14; recorded start 2023-12-14
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: 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.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 49 other studies in this databaseCounted from the lead sponsor named in the record (NRG Oncology)
Present: 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.

Résumé

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.

Affections

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

Éligibilité

Éligibilité
Sexe	Homme
Âges	18 Years – Aucun maximum
Volontaires sains	Non

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Conception de l'étude
Type d'étude	Interventionnelle
Phase	Phase 3
Répartition	Randomisée
Modèle d'intervention	PARALLEL
Objectif principal	TREATMENT
Insu	NONE (0)
Recrutement	1 209 participants recherchés

Promoteur et collaborateurs

NRG Oncology Promoteur

Groupes et interventions

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.

Interventions

Intervention Biospecimen Collection
Undergo blood and urine sample collection
Intervention Bone Scan
Undergo bone scan
Intervention Computed Tomography
Undergo CT or PET/CT
Radiothérapie External Beam Radiation Therapy
Undergo EBRT
Intervention Magnetic Resonance Imaging
Undergo MRI
Intervention Positron Emission Tomography
Undergo PET/CT
Autre Quality-of-Life Assessment
Ancillary studies
Autre Questionnaire Administration
Ancillary studies
Radiothérapie Stereotactic Body Radiation Therapy
Undergo SBRT

Critères de jugement

Critère de jugement principal
Metastasis-free survival (MFS)
Based on conventional imaging. Median MFS time comparing the curves.
Délai From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years
Critère de jugement secondaire
Failure-free survival
Median failure-free survival time comparing the curves.
Délai From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years
Critère de jugement secondaire
Overall survival
Median survival time comparing the curves.
Délai 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
Critère de jugement secondaire
MFS
Median MFS time comparing the curves.
Délai From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years
Critère de jugement secondaire
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.
Délai Up to 15 years
Critère de jugement secondaire
Urinary incontinence
Proportion of patients with a decline, as measured by the urinary incontinence domain of the Expanded Prostate Cancer Index Composite (EPIC-26).
Délai Up to 5 years
Critère de jugement secondaire
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).
Délai Up to 5 years
Critère de jugement secondaire
Bowel function
Proportion of patients with a decline, as measured by the bowel domain of the Expanded Prostate Cancer Index Composite (EPIC-26).
Délai Up to 5 years
Critère de jugement secondaire
Fatigue
Proportion of patients with a decline, as measured by the Patient Reported Outcomes Measurement Information System-Fatigue.
Délai Up to 5 years
Autre critère de jugement
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.
Délai Up to 5 years
Autre critère de jugement
Cost
Measured by the Functional Assessment of Chronic Illness Therapy-COST.
Délai Up to 1 year
Autre critère de jugement
Estimate of treatment effect by sex
Will estimate the primary outcome treatment effect and the corresponding 95% confidence intervals (CIs) by sex.
Délai Up to 15 years
Autre critère de jugement
Estimate of treatment effect by race
Will estimate the primary outcome treatment effect and the corresponding 95% CIs by race.
Délai Up to 15 years
Autre critère de jugement
Estimate of treatment effect by ethnicity
Will estimate the primary outcome treatment effect and the corresponding 95% CIs by ethnicity.
Délai Up to 15 years

Dates

Dates
Date de début	14 décembre 2023 (réelle)
Achèvement principal	31 mars 2036 (estimée)
Achèvement	31 mars 2041 (estimée)
Première publication	14 juillet 2023 (réelle)
Dernière mise à jour	10 septembre 2026
Résultats publiés	Non précisé dans la fiche du registre
Statut vérifié pour la dernière fois	septembre 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

409 sites sont en recrutement

Canada

Canada
Établissement	Ville	État ou région	Statut
CHUM - Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec	En recrutement
The Research Institute of the McGill University Health Centre (MUHC)	Montreal	Quebec	En recrutement
CIUSSSEMTL-Hopital Maisonneuve-Rosemont	Montreal	Quebec	En recrutement
Ottawa Hospital and Cancer Center-General Campus	Ottawa	Ontario	En recrutement
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)	Québec	Quebec	En recrutement
Atlantic Health Sciences Corporation-Saint John Regional Hospital	Saint John	New Brunswick	En recrutement
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont	Sherbrooke	Quebec	En recrutement
Odette Cancer Centre- Sunnybrook Health Sciences Centre	Toronto	Ontario	En recrutement
University Health Network-Princess Margaret Hospital	Toronto	Ontario	En recrutement

Hong Kong

Hong Kong
Établissement	Ville	État ou région	Statut
Pamela Youde Nethersole Eastern Hospital	Chai Wan		Suspendu

Switzerland

Switzerland
Établissement	Ville	État ou région	Statut
Kantonsspital Aarau	Aarau		En recrutement

United States

United States
Établissement	Ville	État ou région	Statut
Cleveland Clinic Akron General	Akron	Ohio	En recrutement
University of New Mexico Cancer Center	Albuquerque	New Mexico	En recrutement
Alton Memorial Hospital	Alton	Illinois	En recrutement
American Fork Hospital / Huntsman Intermountain Cancer Center	American Fork	Utah	En recrutement
McFarland Clinic - Ames	Ames	Iowa	En recrutement
University of Michigan Rogel Cancer Center	Ann Arbor	Michigan	En recrutement
Trinity Health Saint Joseph Mercy Hospital Ann Arbor	Ann Arbor	Michigan	En recrutement
Langlade Hospital and Cancer Center	Antigo	Wisconsin	En recrutement
Kaiser Permanente-Deer Valley Medical Center	Antioch	California	En recrutement
Northwest Wisconsin Cancer Center	Ashland	Wisconsin	En recrutement
Duluth Clinic Ashland	Ashland	Wisconsin	En recrutement
Emory Saint Joseph's Hospital	Atlanta	Georgia	En recrutement
Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia	En recrutement
Emory Proton Therapy Center	Atlanta	Georgia	En recrutement
Emory University Hospital Midtown	Atlanta	Georgia	En recrutement
Grady Health System	Atlanta	Georgia	En recrutement
Advocate Outpatient Center - Aurora	Aurora	Illinois	En recrutement
UCHealth University of Colorado Hospital	Aurora	Colorado	En recrutement
Mount Sinai Comprehensive Cancer Center at Aventura	Aventura	Florida	En recrutement
UH Seidman Cancer Center at UH Avon Health Center	Avon	Ohio	En recrutement
Johns Hopkins University/Sidney Kimmel Cancer Center	Baltimore	Maryland	En recrutement
Veterans Administration Medical Center-Baltimore	Baltimore	Maryland	En recrutement
University of Maryland/Greenebaum Cancer Center	Baltimore	Maryland	En recrutement
Maryland Proton Treatment Center	Baltimore	Maryland	En recrutement
Advocate Good Shepherd Hospital	Barrington	Illinois	En recrutement
MaineHealth Coastal Cancer Treatment Center	Bath	Maine	En recrutement
Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana	En recrutement
Bay Pines VA Healthcare System	Bay Pines	Florida	En recrutement
Northwell Health Imbert Cancer Center	Bay Shore	New York	En recrutement
UHHS-Chagrin Highlands Medical Center	Beachwood	Ohio	En recrutement
UPMC-Heritage Valley Health System Beaver	Beaver	Pennsylvania	En recrutement
UM Upper Chesapeake Medical Center	Bel Air	Maryland	En recrutement
Nebraska Medicine-Bellevue	Bellevue	Nebraska	En recrutement
PeaceHealth Saint Joseph Medical Center	Bellingham	Washington	En recrutement
Sanford Joe Lueken Cancer Center	Bemidji	Minnesota	En recrutement
Saint Charles Health System	Bend	Oregon	En recrutement
Central Vermont Medical Center/National Life Cancer Treatment	Berlin Corners	Vermont	En recrutement
Tower Cancer Research Foundation	Beverly Hills	California	En recrutement
Billings Clinic Cancer Center	Billings	Montana	En recrutement

363 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

Aucun changement n'a été enregistré depuis que nous avons intégré cette fiche pour la première fois.

Un changement est enregistré chaque fois que le promoteur met à jour la fiche du registre. Le statut, les dates, le recrutement et les sites apparaissent ici au fur et à mesure de leur évolution.

Registre: ClinicalTrials.gov · NCT########

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