Know Cancer

forgot password

Prostate Phytochemical & PUFA Intervention - a Phase I/II Study

Phase 1/Phase 2
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

Prostate Phytochemical & PUFA Intervention - a Phase I/II Study

A total of 102 patients with localized prostate cancer will be included in the study. A the
time of inclusion, the participants will be randomized to three groups.

The intervention groups includes; control group, tomato group and multi-diet group. The
intervention period is three week and will be completed before prostatectomy or radiation

Biomarkers og inflammation includes: acute phase proteins, cytokines, chemokines and other
inflammatory mediators. Biomarker of antioxidant status includes vitamin C, vitamin E,
glutathione, carotenoids, total antioxidant capacity and total phenolics. Oxidative stress
markers includes; malondialdehyde, isoprostanes, 8-hydroxy-deoxyguanosine, oxidized vitamin
C, total lipidperoxides (d-ROM) and protein carbonyls.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

serum prostate specific antigen

Outcome Time Frame:

Baseline, after intervention, follow-up

Safety Issue:


Principal Investigator

Wolfgang Lilleby, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rikshospitalet-Radiumhospitalet, Oslo


Norway: Directorate of Health

Study ID:




Start Date:

June 2007

Completion Date:

December 2014

Related Keywords:

  • Prostate Cancer
  • Prostate cancer
  • PSA
  • antioxidant
  • phytochemical
  • tomatoes
  • PUFA
  • selenium
  • soy
  • pomegranate
  • grapes
  • Prostatic Neoplasms