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Prostate CancerPhase 1/2NCT00433797

Dietary Intervention With Phytochemicals and Polyunsaturated Fatty Acids in Prostate Cancer Patients

A Phase 1/2 study testing Prostate cancer, phytochemical and PUFA in people with Prostate Cancer, run by University of Oslo at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Any age, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Prostate cancer, phytochemical and PUFA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteNorway
Study dates
Jun 2007to Dec 2013
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Oslo Universuty Hospital, Radiumhospitalet and Aker

    Oslo, 0310

Other trials in Norway

About this study

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

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

Read the detailed description

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 therapy.

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.

Conditions
Prostate Cancer
Being tested
Prostate cancer, phytochemical and PUFA
Keywords
Prostate cancer, PSA, antioxidant, phytochemical, tomatoes, PUFA, selenium, soy, pomegranate, grapes
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prostate cancer, phytochemical and PUFADietary supplement

    Also called PFPI

    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.

Study groups in NCT00433797
Study groupRoleWhat they receive
1ExperimentalTomato
Receives: Dietary Supplement: Prostate cancer, phytochemical and PUFA
2ExperimentalMulti-diet
Receives: Dietary Supplement: Prostate cancer, phytochemical and PUFA
3Active comparatorControl
Receives: Dietary Supplement: Prostate cancer, phytochemical and PUFA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. serum prostate specific antigen

    Measured: Baseline, after intervention, follow-up

Secondary outcomes (6)

  1. oxidative stress biomarkers in blood, tissue and urine

    Measured: Baseline, after intervention, follow-up

  2. antioxidant status biomarkers in blood, tissue and urine

    Measured: Baseline, after intervention, follow-up

  3. oxidative damage biomarkers in blood, tissue and urine

    Measured: Baseline, after intervention, follow-up

  4. inflammation biomarkers in blood, tissue and urine

    Measured: Baseline, after intervention, follow-up

  5. Apoptose markers in prostate tissue

    Measured: Baseline, after intervention, follow-up

  6. DNA microarrays in blood cells and prostate tissue

    Measured: Baseline, after intervention, follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionMar 2012
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00433797
Sponsor's protocol ID
PFPI
Other IDs
S-06187 (REK Sør), 2006-18 (RRHF)
Status last verified
Dec 2013
First submitted
9 Feb 2007
Last updated
19 Dec 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 27406859

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Prostate cancer, phytochemical and PUFA in people with Prostate Cancer, run by University of Oslo at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

serum prostate specific antigen (time frame: Baseline, after intervention, follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00433797, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2013.

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