- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00941915
Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer (SMART)
17. november 2021 opdateret af: Duke University
A Phase II Study of Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer Using Continuous Real-time Evaluation of Prostate Motion and IMRT Plan Reoptimization Based on the Anatomy of the Day
The purpose of this study is to evaluate the incidence of urinary and gastrointestinal acute and late side effects in patients treated with stereotactic body radiotherapy (SBRT) to the prostate.
Stereotactic radiation therapy is given as five treatments over a 2-3 week period.
The prostate is localized and the plan is reoptimized as needed prior to each treatment.
Studieoversigt
Detaljeret beskrivelse
This protocol requires radiation treatments to be performed with a stereotactic technique with the use of a 3-D coordinate system defined by implanted transponders (i.e.
Calypso) or use of the ExacTrac system and/or use cone-beam CT (CBCT) with fiducial markers.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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North Carolina
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Durham, North Carolina, Forenede Stater, 27710
- Duke University Medical 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
40 år til 82 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- Histologically confirmed diagnosis of adenocarcinoma of the prostate within 365 days of study enrollment
- History/physical examination with digital rectal examination of the prostate within 8 weeks prior to study enrollment
- Gleason score less than or equal to 7
- Clinical Stage T1-T2c
- PSA
- less than or = 15 ng/ml prior to start of therapy if Gleason < or = 6 or
- less than or = 10 ng/ml prior to start of therapy if Gleason = 7
- Zubrod Performance Status 0-1
- Age > 40
Exclusion Criteria:
- Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (Carcinoma in situ of the bladder or oral cavity is permissible)
- Evidence of distant metastases
- Regional lymph node involvement
- Significant urinary obstruction
- Estimated prostate gland > 100 grams
- Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
- Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
- Previous hormonal therapy, such as LHRH agonists (e.g. goserelin, leuprolide), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or surgical castration (bilateral orchiectomy) or planned concurrent androgen deprivation therapy
- Previous or concurrent cytotoxic chemotherapy for prostate cancer
- Prosthetic implants in the pelvic region that contain metal or conductive materials (e.g., an artificial hip).
- Severe, active comorbidity
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: Stereotactic Radiotherapy
Five fractions of 7.4 Gy each
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Five fractions of 7.4 Gy.
The total dose will be 37 Gy.
A minimum of 36 hours and a maximum of 96 hours should separate each treatment.
No more than 3 fractions will be delivered per week.
The total duration of treatment will be no shorter than 10 days and no longer than 18 days.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With Genitourinary Acute Toxicity
Tidsramme: </= 90 days post radiation treatment, a total of 90 days
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Genitourinary Acute Toxicity is defined as Grade 3 or higher occurring within 90 days from the end of radiation treatment
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</= 90 days post radiation treatment, a total of 90 days
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Number of Participants With Genitourinary Late Toxicity
Tidsramme: >90 days from the end of treatment, up to 3 years
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Genitourinary Late Toxicity is defined as Grade 3 or higher occurring >90 days from the end of radiation treatment
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>90 days from the end of treatment, up to 3 years
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Number of Participants With Gastrointestinal Acute Toxicity
Tidsramme: </= 90 days post radiation treatment, a total of 90 days
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Gastrointestinal Acute Toxicity is defined as Grade 3 or higher occurring within 90 days of the end of radiation treatment
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</= 90 days post radiation treatment, a total of 90 days
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Number of Participants With Gastrointestinal Late Toxicity
Tidsramme: >90 days from the end of treatment, up to 3 years
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Gastrointestinal Late Toxicity is defined as Grade 3 or higher occurring > 90 days from the end of radiation treatment
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>90 days from the end of treatment, up to 3 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Disease Free Survival
Tidsramme: 5 yrs
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5 yrs
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Quality of Life, as Measured by the Expanded Prostate Cancer Index Composite (EPIC-26) Short Form
Tidsramme: 3 years post-treatment
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The EPIC-26 Short Form is a 13-item questionnaire.
Scores range from 0-100, with higher scores representing better quality of life.
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3 years post-treatment
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: William R Lee, MD, Duke University
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.
Generelle publikationer
- Peeters ST, Heemsbergen WD, Koper PC, van Putten WL, Slot A, Dielwart MF, Bonfrer JM, Incrocci L, Lebesque JV. Dose-response in radiotherapy for localized prostate cancer: results of the Dutch multicenter randomized phase III trial comparing 68 Gy of radiotherapy with 78 Gy. J Clin Oncol. 2006 May 1;24(13):1990-6. doi: 10.1200/JCO.2005.05.2530.
- Zietman AL, DeSilvio ML, Slater JD, Rossi CJ Jr, Miller DW, Adams JA, Shipley WU. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA. 2005 Sep 14;294(10):1233-9. doi: 10.1001/jama.294.10.1233. Erratum In: JAMA. 2008 Feb 27;299(8):899-900.
- Madsen BL, Hsi RA, Pham HT, Fowler JF, Esagui L, Corman J. Stereotactic hypofractionated accurate radiotherapy of the prostate (SHARP), 33.5 Gy in five fractions for localized disease: first clinical trial results. Int J Radiat Oncol Biol Phys. 2007 Mar 15;67(4):1099-105. doi: 10.1016/j.ijrobp.2006.10.050.
- Boyer MJ, Papagikos MA, Kiteley R, Vujaskovic Z, Wu J, Lee WR. Toxicity and quality of life report of a phase II study of stereotactic body radiotherapy (SBRT) for low and intermediate risk prostate cancer. Radiat Oncol. 2017 Jan 13;12(1):14. doi: 10.1186/s13014-016-0758-8.
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)
9. november 2009
Primær færdiggørelse (Faktiske)
1. februar 2017
Studieafslutning (Faktiske)
17. juli 2020
Datoer for studieregistrering
Først indsendt
17. juli 2009
Først indsendt, der opfyldte QC-kriterier
17. juli 2009
Først opslået (Skøn)
20. juli 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. januar 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. november 2021
Sidst verificeret
1. november 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pro00018266
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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