NCT00433797

Brief Summary

We will study the effect of dietary intervention in patients with prostate cancer. Outcomes include serum PSA kinetics, as well as biomarkers of inflammation, antioxidant status, oxidative stress and oxidative damage in blood cells, plasma, urine and prostate tissues

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P75+ for phase_1 prostate-cancer

Timeline
Completed

Started Jun 2007

Longer than P75 for phase_1 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 12, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 19, 2013

Status Verified

December 1, 2013

Enrollment Period

4.8 years

First QC Date

February 9, 2007

Last Update Submit

December 18, 2013

Conditions

Prostate Cancer

Keywords

Prostate cancerPSAantioxidantphytochemicaltomatoesPUFAseleniumsoypomegranategrapes

Outcome Measures

Primary Outcomes (1)

  • serum prostate specific antigen

    Baseline, after intervention, follow-up

Secondary Outcomes (6)

  • oxidative stress biomarkers in blood, tissue and urine

    Baseline, after intervention, follow-up

  • antioxidant status biomarkers in blood, tissue and urine

    Baseline, after intervention, follow-up

  • oxidative damage biomarkers in blood, tissue and urine

    Baseline, after intervention, follow-up

  • inflammation biomarkers in blood, tissue and urine

    Baseline, after intervention, follow-up

  • Apoptose markers in prostate tissue

    Baseline, after intervention, follow-up

  • +1 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL

Tomato

Dietary Supplement: Prostate cancer, phytochemical and PUFA

2

EXPERIMENTAL

Multi-diet

Dietary Supplement: Prostate cancer, phytochemical and PUFA

3

ACTIVE COMPARATOR

Control

Dietary Supplement: Prostate cancer, phytochemical and PUFA

Interventions

Prostate cancer, phytochemical and PUFADIETARY_SUPPLEMENT

Patients with localized prostate cancer are supplemented with either tomato or a multi-diet cinsisting of grape juice, pomegranate juice, tomato, green tea, black tea, soy, selenium and PUFAs for 3 weeks.

Also known as: PFPI
123

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adenoarcinoma (as confirmed by histology)
  • pN0/NXM0 (TNM/UICC 2002) and at least one negative prognosis factor for HDR-BT or low risk profile with the use of radical prostatectomy.
  • Serum PSA\< 20 ng/mL, and Gleason score =\>6 or T1c- T3a, prostate volume \< 60mL
  • Performance status 0-1
  • Normal WBC and thromocytes, Hb \>11g/dl

You may not qualify if:

  • No previous endocrine treatment
  • Life expectancy \> 5 år
  • No possible co-morbidity (CVD, COPD, diabetes type I, vasculatory syndromes or inflammatory diseases that may affect quality of life and radiation therapy)
  • Urinary retention, incontinens or IPPS score \<12

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo Universuty Hospital, Radiumhospitalet and Aker

Oslo, 0310, Norway

Location

Related Publications (1)

  • Paur I, Lilleby W, Bohn SK, Hulander E, Klein W, Vlatkovic L, Axcrona K, Bolstad N, Bjoro T, Laake P, Tasken KA, Svindland A, Eri LM, Brennhovd B, Carlsen MH, Fossa SD, Smeland SS, Karlsen AS, Blomhoff R. Tomato-based randomized controlled trial in prostate cancer patients: Effect on PSA. Clin Nutr. 2017 Jun;36(3):672-679. doi: 10.1016/j.clnu.2016.06.014. Epub 2016 Jun 30.

    PMID: 27406859DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

PhytochemicalsFatty Acids, Unsaturated

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biological FactorsFatty AcidsLipids

Study Officials

  • Wolfgang Lilleby, MD

    Rikshospitalet-Radiumhospitalet, Oslo

    PRINCIPAL INVESTIGATOR

  • Sigbjørn Smeland, MD, PhD.

    Rikshospitalet-Radiumhospitalet, Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 9, 2007

First Posted

February 12, 2007

Study Start

June 1, 2007

Primary Completion

March 1, 2012

Study Completion

December 1, 2013

Last Updated

December 19, 2013

Record last verified: 2013-12

Locations

NO(1)