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

• Conditions: ocalized cancer of the prostate.

• Registration Number: EUCTR2006-006679-18-NO
• Lead Sponsor: niversity of Oslo, institute for basic medical sciences, department of nutrition.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified