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Early Changes In Multiparametric MRI In Prostate Cancer

22. maj 2020 opdateret af: Fiona Fennessy, Dana-Farber Cancer Institute

Early Changes in Multiparametric MRI in Response to Neoadjuvant Androgen Deprivation and External Beam Radiation Therapy for Prostate Cancer

In this research study, the investigators are trying to determine if there are measurable changes in prostate MRI that will help predict those who will or will not respond to Androgen Deprivation Therapy (ADT) and External Beam Radiation Therapy (EBRT) The first baseline prostate MRI prior to the start of treatment is standard of care. The participant's ADT/EBRT treatment is also standard of care, as advised by their doctor. It is the 3 follow up prostate MRIs during ADT/EBRT treatment, and 4 follow up serum PSA levels that are part of this research study.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

If the participant chooses to take part in this research study, the participant will have 3 follow up prostate MRIs during a 6 month time period, while the participant is having their ADT/EBRT treatment. These follow-up prostate MRIs will use a standard imaging protocol without the use of an endorectal coil. The participant will also have a total of 4 blood samples to measure serum PSA. 1-2 mls (just less than ½ teaspoon) will be taken for each sample.

Research Study Plan

  • Baseline Visit (routine standard of care screening visit): PSA blood test and prostate MRI
  • Visit 1 (8 weeks after starting ADT): PSA blood test and prostate MRI
  • Visit 2 (6 weeks after starting EBRT): PSA blood test and prostate MRI
  • Visit 3 (on last day of EBRT): PSA blood test
  • Visit 4 (6 months after starting ADT): PSA blood test and prostate MRI

Planned Follow-up: The investigator would like to keep track of the participant's prostate cancer status while they continue to see their doctor at DFCI. The investigators would like to do this by collecting the following data from the participant's medical records, to look at long-term outcome of their ADT/EBRT treatment.

  • PSA values
  • Clinical results of your treatment. The investigator will not contact the participant to obtain this information.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

15

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, Forenede Stater, 02215
        • Dana Farber Cancer Institute

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:

  • Adult males with unfavorable intermediate- to high-risk localized disease, defined as having one of the following three categories, Clinical or radiographic T2b-T4 primary tumor or Gleason score 7-10 in any core, or PSA ≥ 10 prior to initiation of therapy
  • Patients are deemed suitable for therapy with ADT and EBRT.
  • Subjects must to able to provide informed written consent prior to study entry.

Exclusion Criteria:

  • The standard exclusion criteria for MRI exams will apply which include patients with pacemakers, non-compatible intra-cranial vascular clips, inner ear implants, and severe claustrophobia.
  • Patients who because of age, general medical or psychiatric condition, or physiologic status unrelated to the presence of prostate cancer are unlikely to be candidates for repeat MRIs, or cannot give valid informed consent.
  • Patients unwilling or unable to undergo the multiparametric MRI exam (non-endorectal coil).
  • Patients with a history of allergic reaction to latex or Gadolinium containing intravenous contrast agents.
  • Individuals with renal disease or other contraindications to gadolinium will be excluded. The BWH standard MRI contrast screening criteria will be used to establish renal status.
  • Patients who have had prior prostatectomy or prior androgen therapy.
  • Patients with hip implant or any other metallic implant or device that results in significant distortion of the local magnetic field and compromise of the quality of the multiparametric MRI data.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: MRIs and PSA Blood Test
  • Visit 1 (8 weeks after starting ADT): PSA blood test and prostate MRI
  • Visit 2 (6 weeks after starting EBRT): PSA blood test and prostate MRI
  • Visit 3 (on last day of EBRT): PSA blood test
  • Visit 4 (6 months after starting ADT): PSA blood test and prostate MRI
Enhed: MR
Andet: PSA Blood Test
Serum PSA will also be subsequently checked on the same day as each follow-up MR is performed, i.e. TP 1, 2 and 3, and right after finishing EBRT. 1-2 mls of blood will be sampled per blood test.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation Between MRI Parameter at Visit 1 and Nadir PSA
Tidsramme: 2 months after starting ADT (Visit 1)
Pearson correlation coefficient between MRI parameters at visit 1 and nadir PSA
2 months after starting ADT (Visit 1)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation Between MRI Parameter at Visit 2 With Nadir PSA
Tidsramme: 6 weeks after starting EBRT (Visit 2)
Pearson correlation coefficient between MRI parameters at visit 2 with nadir PSA
6 weeks after starting EBRT (Visit 2)

Samarbejdspartnere og efterforskere

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

Sponsor

Dana-Farber Cancer Institute

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Fiona Fennessy, MD, PhD, Dana-Farber Cancer Institute

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

1. december 2013

Primær færdiggørelse (Faktiske)

1. juni 2017

Studieafslutning (Faktiske)

1. juni 2017

Datoer for studieregistrering

Først indsendt

8. oktober 2013

Først indsendt, der opfyldte QC-kriterier

8. oktober 2013

Først opslået (Skøn)

10. oktober 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. maj 2020

Sidst verificeret

1. maj 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 13-343
  • U01CA151261 (U.S. NIH-bevilling/kontrakt)

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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Placeringer

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