Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy in Early Stage, Low Volume Prostate Cancer
19. marts 2018 opdateret af: Memorial Sloan Kettering Cancer Center
Phase II Study Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy Early Stage, Low Volume in Prostate Cancer
The purpose of this study is to see what side effects a type of radiation treatment called focal brachytherapy has in treating early stage prostate cancer.
The study is also looking at how useful focal brachytherapy will be in treating prostate cancer.
Additionally, the investigators would like to see how this type of treatment impacts quality of life.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
3
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New York
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New Hyde Park, New York, Forenede Stater, 11040
- North Shore LIJ
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New York, New York, Forenede Stater, 10065
- Memorial Sloan Kettering Cancer Center
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Texas
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Houston, Texas, Forenede Stater, 77030
- Md Anderson Cancer Center
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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
21 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- Men ≥ 21 years of age with a life expectancy estimated to be > 10-years.
- Diagnosis of adenocarcinoma of the prostate confirmed by MSKCC or participating site pathology review.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Prostate cancer clinical stage T1c-T2a
- PSA < 10ng/mL (this will be the PSA level prompting the prostate biopsy)
- MRI evidence of one-sided disease performed within 3 months of registration
- Prostate size <60 cc at time of treatment- if the prostate is larger, hormonal therapy is allowed to achieve the required size Screening biopsy parameters:
- Minimum of 10 biopsy cores
- Gleason grade 7 in two cores or less, with no primary Gleason grade 4 or 5 in any cores
- Unilateral cancer (only right-sided or left-sided, not bilateral)
- No more than 50 % cancer in any one biopsy core
- No more than 25 % of cores containing cancer
- Repeat transrectal or transperineal prostate biopsy that must meet the following parameters:
- Minimum of 12 biopsy cores
- Unilateral cancer (only right-sided or left-sided, not bilateral)
- Gleason grade 7 in two cores or less, with no primary Gleason grade 4 or 5 in any cores
- No more than 50 % cancer in any one biopsy core
- No more than 25 % of cores containing cancer
Subject Exclusion Criteria:
- Medically unfit for anesthesia
- Evidence or suspicion of extracapsular extension on MRI
- IPSS score > 18
- Unable to receive MRI
- Prior radiotherapy for the current disease
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 |
|---|---|
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Eksperimentel: Prostate Biopsy, Focal Brachytherapy , Assessment of QOL
This is a non-randomized, Phase II study examining the tolerance profile (primary endpoint) as well as the secondary endpoints of QOL changes, efficacy and the correlation of post-treatment MRI findings with post-treatment biopsy outcomes in men with early stage low volume prostate cancer treated with focal brachytherapy.
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A re-staging transrectal or transperineal ultrasound-guided prostate biopsy as currently performed at participating institutions.
Focal brachytherapy will be performed at 8 weeks following the transrectal or transperineal biopsy or sooner if the patient has recovered from the repeat biopsy and the treating physician determines it is safe to proceed with treatment.
The regions will be targeted with the prescription dose and receive 144 Gy of Iodine-125 (I-125).
The quality-of-life assessment will focus on erectile function, urinary function, bowel function, and general health related quality of life.
The patients will complete this assessment at baseline and then approximately 3 ± 1 months, 6 ± 1 months, 12 ± 2 months, 18 ± 2 months, and 24 ± 2 months after treatment.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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To Assess the Late Toxicity Outcomes
Tidsramme: 6 months to 2 years
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focal brachytherapy in patients with low risk prostate cancer This study will utilize the toxicity grading scale Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
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6 months to 2 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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To Evaluate the Local Tumor Control After Focal Brachytherapy
Tidsramme: 12 and 24 months
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as measured by the ability to obtain all negative biopsy cores 12 and 24 months after completion of therapy in the hemi-gland of where the focal therapy was administered.
"All negative" means no prostate cancer;
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12 and 24 months
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To Evaluate the Change From Baseline in QOL Indicators
Tidsramme: baseline and then approximately 3 ± 1 months, 6 ± 1 months, 12 ± 2 months, 18 ± 2 months, and 24 ± 2 months after treatment
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Following focal brachytherapy in patients with early stage low volume localized prostate cancer.
The scales to measure these domains were derived from the previously validated MSKCC Prostate-Health Related Quality of Life Questionnaire (PHRQOLQ
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baseline and then approximately 3 ± 1 months, 6 ± 1 months, 12 ± 2 months, 18 ± 2 months, and 24 ± 2 months after treatment
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To Correlate Post-treatment MRI Findings With Post-treatment Biopsy Outcomes
Tidsramme: 2 years
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Post-treatment MRI outcome is defined as a 3-level categorical variable: positive, negative and undetermined.
Post-treatment biopsy outcome is defined as a binary variable: positive and negative.
We will examine the correlation between the 12-month MRI and 12-month biopsy, and between the 24-month MRI and 24-month biopsy.
The correlation will be assessed by a Fisher exact test.
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2 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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
1. maj 2011
Primær færdiggørelse (Faktiske)
6. oktober 2017
Studieafslutning (Faktiske)
6. oktober 2017
Datoer for studieregistrering
Først indsendt
16. maj 2011
Først indsendt, der opfyldte QC-kriterier
16. maj 2011
Først opslået (Skøn)
17. maj 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. oktober 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. marts 2018
Sidst verificeret
1. november 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 11-056
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