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Clinical Trials/EUCTR2006-006679-18-NO
EUCTR2006-006679-18-NOActive, not recruitingNot Applicable

Prostate Phytochemical & PUFA Intervention (PFPI)Norwegian title: Prostata Fytokjemikalie & PUFA Intervensjon (PFPI) - PFPI

niversity of Oslo, institute for basic medical sciences, department of nutrition.0 sitesStarted: January 18, 2007Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
Male

Inclusion Criteria

  • 1.Histologically verified adenocarsinoma
  • 2.pN0/NXM0 (TNM/UICC 2002) and at least one negative prognostic factor for HDR-BT or low-intermediate risk profile by radical prostatectomi.
  • 3.PSA < 50 ng/mL+(Gleason score=>6) or T1c- T3a, prostatevolume < 50mL
  • 4.Performance status 0-1
  • 5.Normal leukocytecount og trombocytecount, Hb >11g/dl
  • 6.Life expectancy > 5 år
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • 1. Previous endocrine treatment
  • 2. Insulindependent diabetes mellitus, vasculitis, inflammatory bowel disease etc. which might influence quality of life or radiotherapy.
  • 3. Urinary retention, urinary incontinence, IPPS score <12 (HDR-BT patients).

Investigators

Sponsor
niversity of Oslo, institute for basic medical sciences, department of nutrition.

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