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Study of Treatment Choice in Patients With Localized Prostate Cancer

23. august 2013 oppdatert av: University College London Hospitals

Evaluating Patient Preferences for the Treatment of Localized Prostate Cancer - A Discrete Choice Experiment

RATIONALE: Gathering information about patients with prostate cancer may help doctors learn more about how patients choose treatment options.

PURPOSE: This study is looking at treatment choice in patients with localized prostate cancer.

Studieoversikt

Status

Ukjent

Forhold

Prostatakreft

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

Primary

To evaluate the importance of prostate cancer treatment characteristics to men with localized prostate cancer.
To determine to what extent men will choose the strengths and weaknesses of one treatment over a different set of strengths and weaknesses of another treatment when making a choice between them.

Secondary

To determine the correlation between attributes that are important to men and baseline demographics, functional status, and disease risk characteristics.

OUTLINE: This is a multicenter study.

Patients complete a 'discrete choice experiment' questionnaire presenting three treatment options based on 8 aspects of treatment. Attributes relevant to men with prostate cancer (e.g., sexual health, urinary function, return to normal activities [work, gardening, sports, shopping]) that apply to surveillance, radical therapies and new minimally-invasive therapies have been selected for consideration. Baseline demographics such as age, working/retired/unemployed/household income, prostate cancer characteristics (PSA level, Gleason grade, stage), baseline functional status (genitourinary function), and final treatment choice will also be collected in order to ascertain whether there is any relationship and association between patient preferences for treatment and these baseline demographics. Individuals will be asked to choose between the three treatment profiles.

Studietype

Intervensjonell

Registrering (Forventet)

432

Fase

Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Storbritannia
- England
  - London, England, Storbritannia, WIT 3AA
    - Rekruttering
    - University College of London Hospitals
    - Ta kontakt med:
      
      Contact Person
      
      Telefonnummer: 44-20-7380-9194
      
      E-post: markemberton1@btinternet.com

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

45 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

DISEASE CHARACTERISTICS:

Histological diagnosis of adenocarcinoma of the prostate on transrectal or transperineal template prostate biopsies
- Clinical stage ≤ T2c N0 M0 (radiological T3a allowed)
  - Local staging imaging as per guidelines to demonstrate localized disease (e.g., MRI, CT, and/or bone scan)
- No metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
No prior prostate surgery for cancer control (e.g., radical prostatectomy, high-intensity focused ultrasound ablation, cryosurgery, or photodynamic therapy) or other treatment for prostate cancer
Gleason grade ≤ 7
Serum PSA ≤ 15 ng/mL

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior radiotherapy
No androgen suppression/hormone treatment within the previous 12 months for prostate cancer

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Helsetjenesteforskning

Hva måler studien?

Primære resultatmål

Resultatmål
Preferences for, and trade-offs between, the attributes of pre-treatment evaluation with general anaesthetic biopsies and post-treatment frequency of biopsies
Treatment choice in respect to risks to sexual function and urinary function, return to normal activities, aim to treat the whole gland or only cancer areas or important cancer areas, retreatment rate, and mortality rate

Sekundære resultatmål

Resultatmål
Correlation between attributes important to men and baseline demographics, functional status, and disease risk characteristics

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University College London Hospitals

Etterforskere

Hovedetterforsker: Mark Emberton, MD, FRCS, MBBS, University College London Hospitals

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. september 2010

Primær fullføring (Forventet)

1. september 2012

Datoer for studieregistrering

Først innsendt

6. august 2010

Først innsendt som oppfylte QC-kriteriene