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A Study of Lower Dose Radiation Therapy for People With Prostate Cancer

4. juni 2026 opdateret af: Memorial Sloan Kettering Cancer Center

Dose dE-eScalaTion IN prostATe radIOtherapy usiNg an MR-Linac in 2 Fractions - A Randomized Trial (DESTINATION 2)

The purpose of this study is to see whether giving a lower (de-escalated) dose of radiation therapy to some parts of the prostate can reduce side effects compared to giving the same (uniform) dose of radiation therapy to the whole prostate.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

54

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Victoria Brennan, MBBCH BAO
  • Telefonnummer: 212-639-8904
  • E-mail: brennanv@mskcc.org

Undersøgelse Kontakt Backup

  • Navn: Zachary Moore, MD, PhD
  • Telefonnummer: 212-639-5803
  • E-mail: MooreZ@mskcc.org

Studiesteder

  • Forenede Stater
    • New Jersey
      • Basking Ridge, New Jersey, Forenede Stater, 07920
        • Rekruttering
        • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
        • Kontakt:
      • Middletown, New Jersey, Forenede Stater, 07748
        • Rekruttering
        • Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
        • Kontakt:
      • Montvale, New Jersey, Forenede Stater, 07645
        • Rekruttering
        • Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
        • Kontakt:
    • New York
      • Commack, New York, Forenede Stater, 11725
        • Rekruttering
        • Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)
        • Kontakt:
      • Harrison, New York, Forenede Stater, 10604
        • Rekruttering
        • Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
        • Kontakt:
      • New York, New York, Forenede Stater, 10065
        • Rekruttering
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
        • Kontakt:
          • Victoria Brennan, MBBCH BAO
          • Telefonnummer: 212-639-8904
      • Uniondale, New York, Forenede Stater, 11553
        • Rekruttering
        • Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Documentation of Disease

    o Patients must have pathologically confirmed prostate adenocarcinoma.

  • Definition of Disease

    • Grade Group (GG) 1, 2, or 3.
    • PSA less than 20 ng/mL prior to starting ADT, if used.
    • Clinical stage of TX, T1 or T2 on digital rectal examination. May have up to radiological stage T3a on MRI. MRI must be performed within 12 months of randomization.
    • MRI-visible tumor(s), all having PIRADS v2 scores of 3, 4, or 5. Each tumor should be able to be delineated on T2 and diffusion-weighted imaging (DWI) +/- dynamic contrast-enhanced imaging (DCE).
    • Tumor nodule visible on MRI should be considered able to be boosted by treating clinician (ie meet urethral constraints while maintaining mandatory GTV coverage) and <2.5cm in maximal dimension.
    • The MRI-defined lesion must be confirmed as malignant on biopsies (Grade group 1, 2, or 3).
    • Patients can be concurrently treated with androgen deprivation therapy (ADT) if this would be standard of care. LHRH analogues, LHRH agonists or Bicalutamide are permitted. ADT is not mandatory where this would usually be omitted. Patients needing greater than 6 months of ADT due to disease parameters should be excluded.
    • No high grade disease (GG3) occult to MRI-defined lesion. As a guide, any pathology for which you would consider surveillance (e.g. GG1, low volume GG2) is allowed outside of the MRI-defined area.
    • No contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia).
    • Prostate volume less than or equal to 90mL.
    • No evidence of nodal or distant metastatic disease.

  • Prior Treatment

    o No history of previous radiation to the prostate, prostate surgery (including transurethral resection of the prostate (TURP)), or other local prostate cancer treatments.

  • Age ≥ 18
  • ECOG Performance Status of ≤ 2 (See Appendix I for performance status criteria)

  • Required Organ Function

    • Adequate hematologic function defined as follows:

      • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
      • Platelets ≥ 100,000 cells/mm3
      • Hemoglobin ≥ 8 g/dl

    • Adequate renal function defined as follows:

      • Creatinine clearance (CrCL) of ≥30 mL/min by the Cockcroft-Gault formula:

CrCl (mL/min) = [140 - age (years)] x weight (kg) / 72 x creatinine (mg / dL) {x 0.85 for female patients}

  • Adequate hepatic function defined as follows:

    • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled)
    • AST and ALT ≤3 x institutional ULN

  • Adequate cardiac function defined as follows:

    • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.

    • To be eligible for this trial, patients should be class 2B or better (see Appendix II: New York Heart Association (NYHA) Functional Classification).

      • Comorbid Conditions
  • No active infection requiring parenteral antibiotic(s).
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • No severe GU symptoms that would preclude extreme hypofractionation per the discretion of the treating physician.
  • No IPSS Score greater than 19.

  • No comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up.

    • Ability of the participant to understand and the willingness to sign a written informed consent form.
    • Willing to consent to contraception during and for 1 year after treatment when applicable.
    • Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Group 1: Uniform dose SBRT
Stråling: MR-guided Stereotactic Body Radiation Therapy
MR-guided 2 fraction Stereotactic Body Radiation Therapy
Andre navne:
  • MR-styret SBRT
Eksperimentel: Group 2: De-escalated dose SBRT
Stråling: MR-guided Stereotactic Body Radiation Therapy
MR-guided 2 fraction Stereotactic Body Radiation Therapy
Andre navne:
  • MR-styret SBRT

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of participants with acute GU toxicities
Tidsramme: 12 weeks from the start of radiation therapy
To estimate the absolute and relative risk of acute GU toxicity (CTCAE v5) when delivering dose de-escalated or uniform dose prostate SBRT, both using a 2-fraction regimen.
12 weeks from the start of radiation therapy

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Memorial Sloan Kettering Cancer Center

Efterforskere

  • Ledende efterforsker: Victoria Brennan, MBBCH BAO, Memorial Sloan Kettering Cancer Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. maj 2026

Primær færdiggørelse (Anslået)

28. maj 2030

Studieafslutning (Anslået)

28. maj 2030

Datoer for studieregistrering

Først indsendt

29. maj 2026

Først indsendt, der opfyldte QC-kriterier

4. juni 2026

Først opslået (Faktiske)

9. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 26-150

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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