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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.

Contatta questo studio

In breve

Fase 31209 partecipanti ricercati413 centri4 paesi

Categorie

Oncologia72%Nefrologia e urologia28%

Registrato in 1 registro

ClinicalTrials.govNCT05946213Apri questa scheda su ClinicalTrials.govSincronizzato 2 settimane fa

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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.

Sintesi

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.

Patologie

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

Idoneità

Idoneità
Sesso	Maschile
Età	18 Years – Nessun massimo
Volontari sani	No

Idoneità come riportata nel registro

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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Disegno dello studio
Tipo di studio	Interventistico
Fase	Fase 3
Assegnazione	Randomizzata
Modello di intervento	PARALLEL
Finalità principale	TREATMENT
Mascheramento	NONE (0)
Arruolamento	1209 partecipanti ricercati

Sponsor e collaboratori

NRG Oncology Sponsor

Bracci e interventi

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.

Interventi

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

Esiti misurati

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

Date

Date
Data di inizio	14 dicembre 2023 (effettiva)
Conclusione primaria	31 marzo 2036 (stimata)
Conclusione	31 marzo 2041 (stimata)
Prima pubblicazione	14 luglio 2023 (effettiva)
Ultimo aggiornamento	10 settembre 2026
Risultati pubblicati	Non indicato nella scheda del registro
Stato verificato l'ultima volta	settembre 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

409 centri stanno reclutando

Canada

Canada
Struttura	Città	Stato o regione	Stato
CHUM - Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec	In reclutamento
The Research Institute of the McGill University Health Centre (MUHC)	Montreal	Quebec	In reclutamento
CIUSSSEMTL-Hopital Maisonneuve-Rosemont	Montreal	Quebec	In reclutamento
Ottawa Hospital and Cancer Center-General Campus	Ottawa	Ontario	In reclutamento
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)	Québec	Quebec	In reclutamento
Atlantic Health Sciences Corporation-Saint John Regional Hospital	Saint John	New Brunswick	In reclutamento
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont	Sherbrooke	Quebec	In reclutamento
Odette Cancer Centre- Sunnybrook Health Sciences Centre	Toronto	Ontario	In reclutamento
University Health Network-Princess Margaret Hospital	Toronto	Ontario	In reclutamento

Hong Kong

Hong Kong
Struttura	Città	Stato o regione	Stato
Pamela Youde Nethersole Eastern Hospital	Chai Wan		Sospeso

Switzerland

Switzerland
Struttura	Città	Stato o regione	Stato
Kantonsspital Aarau	Aarau		In reclutamento

United States

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

Nella scheda del registro sono indicati altri 363 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

Non è stata registrata alcuna modifica da quando abbiamo acquisito questa scheda.

Viene registrata una modifica ogni volta che lo sponsor aggiorna la scheda del registro. Stato, date, arruolamento e centri compaiono qui man mano che cambiano.

Registro: ClinicalTrials.gov · NCT########

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