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The effect of a phytoestrogen intervention and impact of genetic factors on tumor proliferation markers among Swedish patients with prostate cancer: study protocol for the randomized controlled PRODICA trial
Department of Oncology, Division of Clinical Cancer Epidemiology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.
Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Umeå universitet, Medicinska fakulteten, Wallenberg centrum för molekylär medicin vid Umeå universitet (WCMM). Umeå universitet, Medicinska fakulteten, Institutionen för kirurgisk och perioperativ vetenskap, Urologi och andrologi. Department of Urology, Sahlgrenska Cancer Center, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.ORCID-id: 0000-0002-2013-0887
Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Urology, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden.
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2022 (Engelska)Ingår i: Trials, E-ISSN 1745-6215, Vol. 23, nr 1, artikel-id 1041Artikel i tidskrift (Refereegranskat) Published
Abstract [en]

Background: A high intake of phytoestrogens, found in soy, rye, and seeds, is associated with a reduced risk of a prostate cancer diagnosis. Previously, we found that the overall decreased risk of prostate cancer diagnosis in males with a high intake of phytoestrogens was strongly modified by a nucleotide sequence variant in the estrogen receptor-beta (ERβ) gene. However, we do not know if phytoestrogens can inhibit the growth of prostate cancer in males with established diseases. If there is an inhibition or a delay, there is reason to believe that different variants of the ERβ gene will modify the effect. Therefore, we designed an intervention study to investigate the effect of the addition of foods high in phytoestrogens and their interaction with the ERβ genotype on prostate tumor proliferation in patients with prostate cancer.

Method: The PRODICA trial is a randomized ongoing intervention study in patients with low- and intermediate-risk prostate cancer with a Gleason score < 8, prostate-specific antigen (PSA) < 20, and scheduled for radical prostatectomy. The study is conducted at Sahlgrenska University Hospital in Gothenburg, Sweden. The intervention consists of a daily intake of soybeans and flaxseeds (~ 200 mg of phytoestrogens) until the surgery, approximately 6 weeks. The aim is to recruit 200 participants. The primary outcome is the difference in the proliferation marker Ki-67 between the intervention and the control groups. The genotype of ERβ will be investigated as an effect-modifying factor. Secondary outcomes include, e.g., concentrations of PSA and steroid hormones in the blood.

Discussion: The results of the PRODICA trial will contribute important information on the relevance of increasing the intake of phytoestrogens in patients with prostate cancer who want to make dietary changes to improve the prognosis of their cancer. If genetic factors turn out to influence the effect of the intervention diet, dietary advice can be given to patients who most likely benefit from it. Dietary interventions are cost-effective, non-invasive, and result in few mild side effects. Lastly, the project will provide basic pathophysiological insights which could be relevant to the development of treatment strategies for patients with prostate cancer.

Trial registration. ClinicalTrials.gov NCT02759380. Registered on 3 May 2016.

Ort, förlag, år, upplaga, sidor
BioMed Central (BMC), 2022. Vol. 23, nr 1, artikel-id 1041
Nyckelord [en]
Food frequency questionnaire, Gene-diet interaction, Phytoestrogens, Prostate cancer
Nationell ämneskategori
Cancer och onkologi Urologi och njurmedicin
Identifikatorer
URN: urn:nbn:se:umu:diva-202066DOI: 10.1186/s13063-022-06995-2ISI: 000901940900002PubMedID: 36544211Scopus ID: 2-s2.0-85144564652OAI: oai:DiVA.org:umu-202066DiVA, id: diva2:1723533
Forskningsfinansiär
Dr P Håkanssons stiftelse, Maria Hedelin 2014Knut och Alice Wallenbergs Stiftelse, KAW 2015.0114
Anmärkning

Correction: Ahlin, R., Nybacka, S., Josefsson, A. et al. Correction: The effect of a phytoestrogen intervention and impact of genetic factors on tumor proliferation markers among Swedish patients with prostate cancer: study protocol for the randomized controlled PRODICA trial. Trials 24, 187 (2023). DOI: 10.1186/s13063-023-07219-x

Tillgänglig från: 2023-01-03 Skapad: 2023-01-03 Senast uppdaterad: 2024-01-17Bibliografiskt granskad

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