Reduced Planning Target Volume (PTV) Margins for the Treatment of Prostate Cancer Using the Calypso 4D Localization System (PTV)
13. mai 2016 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Forhold
Detaljert 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.
Studietype
Observasjonsmessig
Registrering (Forventet)
40
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Washington
-
Tacoma, Washington, Forente stater, 98431
- Madigan Healthcare System
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2009
Primær fullføring (Forventet)
1. mai 2017
Studiet fullført (Forventet)
1. august 2017
Datoer for studieregistrering
Først innsendt
26. april 2012
Først innsendt som oppfylte QC-kriteriene
1. mai 2012
Først lagt ut (Anslag)
2. mai 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
17. mai 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. mai 2016
Sist bekreftet
1. mai 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- W81XWH-08-2-0174, A-15214.1a
- 207111 (Annen identifikator: Madigan Army IRB)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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