Reduced Planning Target Volume (PTV) Margins for the Treatment of Prostate Cancer Using the Calypso 4D Localization System (PTV)
13. maj 2016 opdateret af: Dusten Macdonald, MD, U.S. Army Medical Research Acquisition Activity
Reduced PTV Margins for the Treatment of Prostate Cancer With IMRT Using Real-Time, State-of-the-Art Motion Tracking With the Calypso 4D Localization System: A Feasibility Study
This prospective study evaluates the clinical utility of a novel real-time localization system allowing for smaller volumes of normal tissue to be included in radiation field and determines dosimetric parameters and adverse effect profiles of radiation therapy using this technology.
Subjects will have beacon transponders implanted into the prostate to more precisely localize the position of the organ during radiation therapy.
Hypothesis: 1. Treatment with highly targeted radiation therapy can be delivered in a daily treatment time consistent with routine clinical practice.
2. Highly targeted radiation therapy with reduced PTV margin will result in a significant decrease in rectal and bladder volume treated.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
This study will seek to establish the clinical feasibility of a novel real-time localization and tracking system for use of reduced PTV margins during intensity modulated radiation therapy (IMRT), which will allow treatment of smaller volumes of normal tissue during radiation therapy. Such a reduction in the PTV margins and the exposure of healthy tissue during treatment may allow for several future improvements in prostate radiotherapy including:
- decreased acute and chronic adverse effects with similar local tumor control
- dose escalation to achieve higher cure rates with similar adverse effects to standard dose treatment
- hypofractionation to shorten the time of, and lower the expense of, treatment without increased adverse effects.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
40
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Washington
-
Tacoma, Washington, Forenede Stater, 98431
- Madigan Healthcare System
-
-
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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with localized prostate cancer for whom definitive radiation therapy is planned to the prostate only or prostate and seminal vesicle only, without ajuvant or neoadjuvant hormornal therpy will be referred by the radiation oncololgists and urologists.
Beskrivelse
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate
- Low Risk: T1a, T1b, T1c, T2a; Gleason Score less than 7, PSA less than or equal to 10
- Intermediate Risk: T2b, T2c; Gleason Score less than or equal to 7, PSA less than or equal to 15
- Ability to comply with study schedule
- Age 40 or older
- Zubrod PS 0 or 1
- Signed informed consent
Exclusion Criteria:
- Node positive or metastatic prostate cancer
- Prior treatment of prostate cancer with surgery, chemotherapy, cryotherapy or brachytherapy
- History of prior pelvic radiotherapy
- History of abdominoperineal resection
- History of HIV infection
- History of chronic prostatitis or chronic cystitis
- History of bleeding disorder or any active anticoagulation (excluding ASA)
- PT or INR outside normal range for institution
- Active implanted devices such as cardiac pacemakers and automatic defibrillators.
- Prosthetic implants in the pelvic region that contain metal or conductive materials (eg., an artificial hip).
- Patients with maximum anterior-posterior separation through the torso minus the height of the center of the prostate greater than 17 cm (technical reason for Calypso System, see appendix 8).
- Prior history of androgen deprivation therapy has been deleted and these patients are allowed on study.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Radiation therapy with reduced treatment margins can be adopted as feasible for routine clinical use
Tidsramme: Approximately 8.5 weeks (43 fractions per pt.)
|
During each radiation treatment fraction, therapists will record set up time, treatment time, total time and number of treatment interventions (repositioning/pausing) as well as the duration of the intervention caused by organ/target motion beyond planning target volume (PTV) margin using real time localization and tracking.
|
Approximately 8.5 weeks (43 fractions per pt.)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Analyze dosimetric characteristics of treatment planning
Tidsramme: usually within the first 2 weeks after beacon placement (done at simulation CT)
|
Standard methods vs. reduced planning target volume expansions will be analyzed:
|
usually within the first 2 weeks after beacon placement (done at simulation CT)
|
|
Assess incidence of acute bladder and rectal toxicity
Tidsramme: approximately 25 months (assessed prior to beacons are placed and then throughout treatment and follow-up)
|
toxicity is based on the RTOG/NCI CTC and EPIC quality of life survey.
|
approximately 25 months (assessed prior to beacons are placed and then throughout treatment and follow-up)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
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. marts 2009
Primær færdiggørelse (Forventet)
1. maj 2017
Studieafslutning (Forventet)
1. august 2017
Datoer for studieregistrering
Først indsendt
26. april 2012
Først indsendt, der opfyldte QC-kriterier
1. maj 2012
Først opslået (Skøn)
2. maj 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. maj 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. maj 2016
Sidst verificeret
1. maj 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- W81XWH-08-2-0174, A-15214.1a
- 207111 (Anden identifikator: Madigan Army IRB)
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 .