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Stereotactic Radiotherapy for Oligometastatic Prostate Cancer (CROP)

6. marts 2022 opdateret af: Dr. Patrick Cheung, Sunnybrook Health Sciences Centre

Comprehensive Stereotactic Radiotherapy for Oligometastatic Prostate Cancer: A Phase I/II Study

This is a study that assesses the safety and efficacy of using stereotactic radiotherapy in conjunction with hormone therapy for patients with metastatic prostate cancer where there are a limited number of metastatic tumours.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Patients will receive androgen deprivation therapy (ADT) for a minimum of 1 year. After this, an intermittent hormone therapy approach will be taken, where ADT will not be restarted until the prostate specific antigen (PSA) reaches a minimum of 10-15 ng/mL. Lupron 30 mg IM will be delivered every 4 months when on ADT.

The prostate (if not previously treated) will be treated to a dose of 35-40 Gy in 5 fractions. All visible nodal metastases will be treated to a dose of 30-35 Gy in 5 fractions. It is very likely that nodal metastases will shrink significantly (often completely) with ADT. In this scenario, the involved nodal regions will be treated to a more modest dose of 25 Gy in 5 fractions (roughly equivalent to a dose of 46 Gy in 23 fractions assuming an α/β value of 1.4). Non-spine bone metastases will be treated to a dose of 30-40 Gy in 5 fractions. Metastases in the brain, spine, lung, liver, and adrenal will be treated according to established stereotactic radiotherapy (SRT) policies at Sunnybrook Odette Cancer Centre. Comprehensive SRT should be delivered within 3 months of starting ADT.

During any "off" period of ADT (before the PSA rises above 10-15 ng/mL), comprehensive SRT can be repeated if there are new oligometastases that become visible. One month after initiation comprehensive SRT, patients will be contacted to assess for acute toxicities.

After completion of radiotherapy to all disease sites, patients will be followed every 3-4 months with PSA testing until the development of castrate resistant prostate cancer. At the same time points, late toxicity and quality of life will be collected for a minimum of 2 years. Computed tomography (CT) of the chest/abdo/pelvis +/- magnetic resonance imaging (MRI) of previously irradiated body sites and bone scan will be performed whenever the PSA reaches ≥ 10 ng/mL (prior to re-starting androgen deprivation therapy during intermittent hormone therapy approach), or at a minimum frequency of once per year.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

90

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Odette Cancer Centre

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  • Able to provide informed consent.
  • ECOG performance status 0-1.
  • Histologic confirmation of prostate adenocarcinoma.
  • Stage IV disease, with up to 5 metastatic tumours outside of the prostate and pelvic lymph nodes.
  • ≤ 3 tumours within any given organ system (e.g. up to 3 brain metastases, or 3 liver metastases).
  • All sites of disease are amenable to stereotactic radiotherapy.

Exclusion Criteria:

  • Castrate resistant prostate cancer.
  • Evidence of spinal cord compression.
  • Previous radiotherapy for current cancer (with the exception of upfront management of the primary prostate tumour, brain metastasis(es) prior to androgen deprivation therapy).
  • Inability to safely treat all sites of visible disease.
  • Prior malignancy within the past 5 years, excluding non-melanoma skin cancer, and in-situ cancer.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Stereotactic radiotherapy
Stereotactic radiotherapy will be delivered to the prostate (if not previously treated) and to all metastatic tumours.
Stråling: stereotactic radiotherapy

Patients will receive ADT for a minimum of 1 year. After this, an intermittent hormone therapy approach will be taken.

The prostate (if not previously treated) will be treated to a dose of 35-40 Gy in 5 fractions. All visible nodal metastases will be treated to a dose of 30-35 Gy in 5 fractions. Non-spine bone metastases will be treated to a dose of 30-40 Gy in 5 fractions. Metastases in the brain, spine, lung, liver, and adrenal will be treated according to established SRT policies at the Sunnybrook Odette Cancer Centre. Comprehensive SRT should be delivered within 3 months of starting ADT.

Andre navne:
  • SBRT, SABR

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of late radiotherapy toxicities after stereotactic radiotherapy to all sites of disease
Tidsramme: cumulative incidence at 2 years
common terminology criteria for adverse events (CTCAE) version 4.0
cumulative incidence at 2 years

Sekundære resultatmål

Resultatmål
Tidsramme
Quality of Life (EORTC QLQ-C30)
Tidsramme: proportion of patients who experience a significant decline in quality of life at 6 months, 12 months, 18 months, and 24 months
proportion of patients who experience a significant decline in quality of life at 6 months, 12 months, 18 months, and 24 months
Time to development of castrate resistant prostate cancer
Tidsramme: through study completion, an average of 2 years
through study completion, an average of 2 years
Radiographic local control of irradiated tumours
Tidsramme: actuarial rate at 2 years
actuarial rate at 2 years
Radiographic "distant" control rate
Tidsramme: actuarial rate at 2 years
actuarial rate at 2 years
Overall survival
Tidsramme: through study completion, an average of 4 years
through study completion, an average of 4 years

Samarbejdspartnere og efterforskere

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

Sponsor

Sunnybrook Health Sciences Centre

Efterforskere

  • Ledende efterforsker: Patrick Cheung, M.D., Toronto Sunnybrook Regional Cancer Centre

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)

1. november 2014

Primær færdiggørelse (Faktiske)

1. december 2021

Studieafslutning (Forventet)

1. december 2022

Datoer for studieregistrering

Først indsendt

3. juli 2015

Først indsendt, der opfyldte QC-kriterier

28. september 2015

Først opslået (Skøn)

30. september 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. marts 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. marts 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CROP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

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 .

Kliniske forsøg med Prostatiske neoplasmer

Kliniske forsøg med stereotactic radiotherapy

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Nigeria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
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