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Study of Blood and Tissue Samples From Patients Receiving Androgen Deprivation for Newly Diagnosed Prostate Cancer

9. januar 2014 oppdatert av: Cancer Research UK

A Study of Changes in the Prostate Following Androgen Deprivation to Investigate Therapy Response and Resistance in Clinical Prostate Cancer

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at blood and tissue samples from patients with prostate cancer receiving androgen deprivation therapy.

Studieoversikt

Status

Ukjent

Forhold

Prostatakreft

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

To identify the molecular and pathophysiological changes which occur during the early stages of androgen deprivation (AD) and during emerging castration-resistant prostate cancer.
To test functional imaging as a non-invasive tool to measure treatment response and validate this using biological endpoints.
To develop clinical models to predict how tumors will respond to AD and identify new targets once AD fails.

OUTLINE:

Group A: Patients likely to receive androgen deprivation (AD) as first-line therapy undergo blood and prostate biopsy sample collection before and after treatment on days 0 and 14 or 90. Patients receive an androgen receptor inhibitor followed by maintenance with a gonadotropin-releasing hormone analogue beginning on day 0. Patients also undergo diffusion-weighted MRI, MR spectroscopic imagining, quantitative T1W mapping, and T1W perfusion sequence.
Group B: Patients already receiving AD undergo blood and prostate biopsy sample collection within 4 weeks of diagnosis of castration-resistant prostate cancer and before initiating any second-line therapy.

Blood and tissue samples are assessed via DNA and RNA genetic analysis, gene expression studies, and comparative genomic hybridization to identify novel markers of androgen response and resistance.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Studietype

Intervensjonell

Registrering (Forventet)

120

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
  - Cambridge, England, Storbritannia, CB2 0RE
    - Rekruttering
    - Cancer Research UK at Cambridge Research Institute
    - Ta kontakt med:
      
      Vincent Gnanapragasam, MD
      
      Telefonnummer: 44-1223-348-363

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

Barn
Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

DISEASE CHARACTERISTICS:

Meets 1 of the following criteria:
- High clinical suspicion of prostate cancer, based on an abnormal digital rectal examination and PSA (> 20 ng/mL)
- Newly diagnosed, castration-resistant prostate cancer
  - Clinical stage ≥ T2c disease
Significant tumor volume on initial diagnostic biopsy (> 50% of cores)
Likely to receive androgen deprivation therapy for prostate cancer

PATIENT CHARACTERISTICS:

No contraindication to transrectal needle biopsy
No contraindication to MRI or prostate needle biopsy

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

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: Ikke-randomisert

Hva måler studien?

Primære resultatmål

Resultatmål
Identification of molecular and pathophysiological changes
Functional imaging as a non-invasive tool to measure treatment response
Development of clinical models to predict tumor response

Samarbeidspartnere og etterforskere

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

Sponsor

Cancer Research UK

Etterforskere

Hovedetterforsker: Vincent Gnanapragasam, MD, Cancer Research UK

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 2008

Primær fullføring (Forventet)

1. august 2013

Datoer for studieregistrering

Først innsendt

27. august 2009

Først innsendt som oppfylte QC-kriteriene