Clinical trial · Interventional
Dietary Intervention With Phytochemicals and Polyunsaturated Fatty Acids in Prostate Cancer Patients
Prostate Phytochemical & PUFA Intervention - a Phase I/II Study
NCT00433797CI-TRIAL-00013105completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prostate cancer, phytochemical and PUFA | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 1
- description
- Tomato
- interventionNames
- Dietary Supplement: Prostate cancer, phytochemical and PUFA
- type
- EXPERIMENTAL
- label
- 2
- description
- Multi-diet
- interventionNames
- Dietary Supplement: Prostate cancer, phytochemical and PUFA
- type
- ACTIVE_COMPARATOR
- label
- 3
- description
- Control
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPaur 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 27406859