- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01227642
Using Ultrasound Spectrum Analysis (USA) to Guide Dose Escalated Prostate Brachytherapy (USA)
11. mars 2016 oppdatert av: Beth Israel Medical Center
Phase I/II Evaluation of Cancer-Specific Imaging Using Ultrasound Spectrum Analysis (USA) to Guide Dose Escalated Prostate Brachytherapy
In standard treatment, the seeds are placed throughout the prostate to treat the entire prostate.
This is done because it was impossible to know where the cancer was located within the prostate.
A new technique has been developed using the same ultrasound imaging that you probably had when you had your biopsy.
Using this technique, areas likely to contain prostate cancer can be identified.In this early study of 15 subjects, we will test if this method to plan your prostate seed implant is safe and can be done as part of regular care.
Areas identified as suspicious for cancer will be treated with higher doses of radiation while those areas not demonstrating cancer will be treated to the standard minimum dose.
The higher dose areas will receive two times the minimum dose the prostate usually receives.
Because this technique is not perfect, those areas not identified as cancerous should be treated in case there is a cancer area that the technique did not identify.
Subjects enrolled in this study will then be followed with this ultrasound technique over the next two years to monitor the changes to the cancerous areas and will undergo a biopsy two years after the procedure.
Subjects will, of course, be monitored to assess the success of the technique and its side effects.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
Prostate brachytherapy is an increasingly popular treatment for clinically localized prostate cancer.In properly selected patients, it is highly effective with biochemical (PSA) disease free survival rates of 80-87% at 5-10 years.However, the technique is currently limited by the inability to localize the cancer within the prostate.
The multifocal nature of prostate cancer is well established.
Because of the inability to know where within the prostate the cancer is located, radiation must be delivered throughout the gland.
Although this blind approach leads to good results, it is clear that there are regions of the prostate and surrounding tissue that are overexposed to radiation while others are underexposed relative to their true need based on their tumor burden and their proximity to the tumor areas.Feleppa et al. at Riverside Research Institute (New York, NY), a non-profit ultrasound research center, have developed an ultrasound-based technique to identify cancer-containing areas within the prostate.
This technique uses current ultrasound equipment already in use for prostate brachytherapy guidance.
By extracting and processing the radiofrequency signal obtained from the ultrasound transducer in ways not done to create the standard B-mode ultrasound image, areas of cancer can be identified and displayed overlying the standard B-mode ultrasound image.In this study, we propose to obtain these ultrasound-based cancer-specific images of the prostate prior to the brachytherapy and use them to direct the dosimetry planning.The primary goal of this study is to demonstrate that this imaging modality can be incorporated into the treatment planning process for brachytherapy.
Furthermore, we wish to demonstrate the improved dosimetry of the cancer-identified regions while maintaining the urethral dose guidelines noted above.
We also wish to compare the differences in dose to the other adjacent normal structures (anterior rectum and right and left neurovascular bundles).
Additionally, we seek to demonstrate, at a minimum, no increased toxicity with this approach and similar disease control rates.
Of course, ultimately the goal will be to demonstrate a superior therapeutic ratio with this technique.
Studietype
Intervensjonell
Registrering (Faktiske)
14
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New York
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New York, New York, Forente stater, 10019
- St.Luke's-Roosevelt Hospital Center
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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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- Clinical stage ≤ T2b according to the American Joint Commission on Cancer 6th Edition28
- PSA ≤ 10 ng/ml
- Gleason sum on biopsy ≤ 6
- Prostate volume ≤ 50 cc
- Willing to continue follow-up for at least two years.
Exclusion Criteria:
- No prior hormone therapy
- No prior radiotherapy
- No history of collagen vascular disease
- No history of inflammatory bowel disease
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: pre-implant transrectal ultrasound images and planning
Transrectal ultrasound session will be performed at a separate session prior to the implant.
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The technique uses current ultrasound equipment already in use for prostate brachytherapy guidance.By extracting and processing the radiofrequency signal obtained from the ultrasound transducer in ways not done to create the standard B-mode ultrasound image, areas of cancer can be identified and displayed overlying the standard B-mode ultrasound image.
Comparing the results with this technique to the results of prostate biopsies demonstrates a high degree of accuracy with the area under the receiver-operator characteristic curve of 0.87, a result superior to any other imaging methods.
an ultrasound-based technique to identify cancer-containing areas within the prostate.
ultrasound-based cancer-specific images of the prostate prior to the brachytherapy and use them to direct the dosimetry planning
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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modified B+K ultrasound-based tissue-type images
Tidsramme: 2 years
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2 years
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Ronald Ennis, MD, St. Luke's-Roosevelt Hospital Center
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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. februar 2007
Primær fullføring (Faktiske)
1. august 2014
Studiet fullført (Faktiske)
1. august 2014
Datoer for studieregistrering
Først innsendt
22. oktober 2010
Først innsendt som oppfylte QC-kriteriene
22. oktober 2010
Først lagt ut (Anslag)
25. oktober 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
14. mars 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. mars 2016
Sist bekreftet
1. mars 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 06-147
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