Feasibility and Safety Study Using Preoperative High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy at High-Risk for Extraprostatic Cancer
4. marts 2015 opdateret af: Memorial Sloan Kettering Cancer Center
Phase I Feasibility and Safety Study Using Preoperative High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy at High-Risk for Extraprostatic Cancer
This study is being done to test the safety of a single high-dose of radiation therapy before radical prostatectomy (removal of the prostate).
The investigators want to find out what effects, good and/or bad, the radiation will have on men undergoing prostatectomy.
The investigators are especially interested in men who are at risk for having cancer cells that have spread outside the prostate.
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Fase
- Fase 1
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 York, New York, Forenede Stater, 10065
- Memorial Sloan Kettering 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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- Biopsy-proven prostate cancer verified at MSKCC. The biopsy will include a minimum of 10 cores
- Radical Prostatectomy (RP) chosen as the therapeutic method
- The size of the prostate will be < 70 cc by transrectal ultrasound or endorectal MRI imaging
- No radiographic evidence of lymph node metastases, bone metastases or soft tissue disease
- Risk of extraprostatic cancer of > 40% based on the MSKCC surgical nomogram
- Age > or = to 18 years
- KPS > or = to 80
- Able to tolerate immobilization cradle positioning
Exclusion Criteria:
- Allergic reaction to intravenous CT contrast (if premedicated, pt will not be excluded)
- Prior radiation to the planned target region
- Patients receiving concurrent chemotherapy
- Neoadjuvant hormonal therapy Luteinizing-hormone-releasing hormone(LHRH)agonist and/or antiandrogen)
- Prior transurethral resection of the prostate
- Normal tissue directly overlying target precluding ability to limit the bowel, bladder, rectum or other tissue to less than or equal to 15-16 Gy dose constraints
- Dominant prostatic lesion within 3 mm from the anterior rectal wall by imaging studies
- Creatinine clearance <60 ml/min/1.73m2
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: High-Dose Single-Fraction Image-Guided Radiotherapy
This will assess the feasibility and safety of this approach in men at high-risk for extraprostatic prostate cancer undergoing RP.
This initial trial has been designed in a manner intended to emphasize patient comfort and safety.
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A baseline DCE-MRI will be obtained prior to the day of radiotherapy treatment.
Immediately following the delivery of radiotherapy another DCE-MRI will be performed to assess for perfusion changes in the prostate resulting from irradiation.
RP will be completed within 6 weeks (+ 2 weeks) of radiation and the RP specimen will be assessed for radiation treatment effect and other pathologic parameters (including surgical margin status) by a dedicated genitourinary pathologist.
Following RP, participants will follow-up with their surgeon every 3 months for one year, with visits alternating between the urologist and the radiation oncologist.
After the first year follow-up will occur at 6 month intervals until the patient is 3 years out from surgery.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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To assess the feasibility and safety of single-fraction image-guided intensity modulated radiotherapy (IG-IMRT).
Tidsramme: 1 year
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Given prior to radical prostatectomy (RP) in men at high risk for extraprostatic cancer.
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1 year
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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To analyze the changes in prostate perfusion induced by single-fraction IG-IMRT.
Tidsramme: 1 before radiation simulation, 1 after radiation treatment
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via dynamic contrast enhanced magnetic resonance imaging (DCE-MRI)
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1 before radiation simulation, 1 after radiation treatment
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To assess the long-term toxicity of intensity modulated radiotherapy (IG-IMRT)
Tidsramme: weeks 3, 6, 9, 12, 18, 24, 30, and 36 months after RP
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Given prior to radical prostatectomy (RP) with respect to urinary function, erectile function, and bowel function.
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weeks 3, 6, 9, 12, 18, 24, 30, and 36 months after RP
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To assess the effect of IG-IMRT on the anticipated positive margin rate at the time of RP.
Tidsramme: 1 year
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1 year
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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. juli 2010
Primær færdiggørelse (Faktiske)
1. august 2011
Studieafslutning (Faktiske)
1. august 2011
Datoer for studieregistrering
Først indsendt
14. juli 2010
Først indsendt, der opfyldte QC-kriterier
14. juli 2010
Først opslået (Skøn)
15. juli 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
6. marts 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. marts 2015
Sidst verificeret
1. marts 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 09-013
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