Effect of lycopene on prostate cancer among native African men: A protocol for an open-label randomized clinical trial in Tanzania

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This randomized clinical trial protocol outlines a 12-month study in Tanzania to evaluate if daily tomato paste improves prostate cancer outcomes by reducing PSA levels and increasing apoptosis.

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This F1000Research article presents a protocol for an open-label randomized clinical trial in Tanzania to evaluate the effect of lycopene on prostate cancer outcomes among native African men. The study design, intervention, and trial conduct details are outlined, aiming to test whether lycopene administration produces measurable effects in this population. A major caveat is that the paper is a protocol rather than a completed results report, so efficacy or safety findings are not yet available. This paper does not explicitly discuss endometriosis or adenomyosis; it was included in the corpus via a keyword match in the upstream search index.

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Abstract

Background: Prostate cancer (PCa) is the most common cancer and the fifth leading cause of death in men worldwide. The treatment of PCa depends on the clinical stage of the disease, prostate-specific antigen (PSA) level, and histology. Lycopene is a bright red carotenoid found in tomatoes, which enhances apoptosis in prostate cells, but its effectiveness has not been studied in East African countries. This study aimed to determine the effectiveness of lycopene from tomato extracts in reducing PSA levels, disease progression, and apoptosis in the prostate glands of men with PCa in Tanzania. Methods This study will be a randomized phase III clinical trial of men diagnosed with PCa in Tanzania. In total, 400 men will be randomized in a 1:1 ratio to receive intervention (n=200) and control (n=200) and followed for 12 months. The intervention arm will receive tomato paste for daily use in addition to the standard treatment, whereas the control arm will only follow the standard of care. The primary endpoints will be a reduction in PSA levels, improved clinical status, and apoptosis of the prostate gland. Data analysis was performed based on the intention-to-treat principle. Descriptive statistics were used to compare average lycopene and PSA levels in the intervention group using T-test and Chi-squared tests. Generalized linear mixed models will be used to further assess the effect of lycopene on PCa progression, urinary symptoms, and PSA reduction. All statistical tests were two-sided at an alpha level of <0.05. Discussion The study used a food supplement as a drug/intervention with minimal or no adverse reactions. However, there is a fear that the control group may not adhere to the protocol after learning the benefits of tomato paste. The study findings will promote the consumption of tomato paste in males diagnosed with PCa to improve the clinical status and reduce disease progression. Trial registration The study has been registered at the Pan African Clinical Trial Registry with registration No PACTR202405488763956.
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Matumaini" }, { "@type": "Person", "name": "Innocent B. Mboya" }, { "@type": "Person", "name": "Margaretha Sariko" }, { "@type": "Person", "name": "Mshangama J. Seif" }, { "@type": "Person", "name": "Alex Mremi" }, { "@type": "Person", "name": "Abdul-Hamid Lukambagire" }, { "@type": "Person", "name": "Sia E. Msuya" }, { "@type": "Person", "name": "Blandina Theophil Mmbaga" }, { "@type": "Person", "name": "Louis Pisters" }, { "@type": "Person", "name": "Alfred K. Mteta" } ], "publisher": { "@type": "Organization", "name": "F1000Research", "logo": { "@type": "ImageObject", "url": "https://f1000research.com/img/AMP/F1000Research_image.png", "height": 480, "width": 60 } }, "image": { "@type": "ImageObject", "url": "https://f1000research.com/img/AMP/F1000Research_image.png", "height": 1200, "width": 150 }, "description": " Background Prostate cancer (PCa) is the most common cancer and the fifth leading cause of death in men worldwide. The treatment of PCa depends on the clinical stage of the disease, prostate-specific antigen (PSA) level, and histology. Lycopene is a bright red carotenoid found in tomatoes, which enhances apoptosis in prostate cells, but its effectiveness has not been studied in East African countries. This study aimed to determine the effectiveness of lycopene from tomato extracts in reducing PSA levels, disease progression, and apoptosis in the prostate glands of men with PCa in Tanzania. Methods This study will be a randomized phase III clinical trial of men diagnosed with PCa in Tanzania. In total, 400 men will be randomized in a 1:1 ratio to receive intervention (n=200) and control (n=200) and followed for 12 months. The intervention arm will receive tomato paste for daily use in addition to the standard treatment, whereas the control arm will only follow the standard of care. The primary endpoints will be a reduction in PSA levels, improved clinical status, and apoptosis of the prostate gland. Data analysis was performed based on the intention-to-treat principle. Descriptive statistics were used to compare average lycopene and PSA levels in the intervention group using T-test and Chi-squared tests. Generalized linear mixed models will be used to further assess the effect of lycopene on PCa progression, urinary symptoms, and PSA reduction. All statistical tests were two-sided at an alpha level of <0.05. Discussion The study used a food supplement as a drug/intervention with minimal or no adverse reactions. However, there is a fear that the control group may not adhere to the protocol after learning the benefits of tomato paste. The study findings will promote the consumption of tomato paste in males diagnosed with PCa to improve the clinical status and reduce disease progression. Trial registration The study has been registered at the Pan African Clinical Trial Registry with registration No PACTR202405488763956. " } { "@context": "http://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": "1", "item": { "@id": "https://f1000research.com/", "name": "Home" } }, { "@type": "ListItem", "position": "2", "item": { "@id": "https://f1000research.com/browse/articles", "name": "Browse" } }, { "@type": "ListItem", "position": "3", "item": { "@id": "https://f1000research.com/articles/13-1114", "name": "Effect of lycopene on prostatecancer among native African men: A protocol..." } } ] } Home Browse Effect of lycopene on prostatecancer among native African men: A protocol... ALL Metrics - Views Downloads Get PDF Get XML Cite How to cite this article Matumaini HK, Mboya IB, Sariko M et al. Effect of lycopene on prostate cancer among native African men: A protocol for an open-label randomized clinical trial in Tanzania [version 1; peer review: awaiting peer review] . F1000Research 2024, 13 :1114 ( https://doi.org/10.12688/f1000research.156203.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol Clinical trial Effect of lycopene on prostate cancer among native African men: A protocol for an open-label randomized clinical trial in Tanzania [version 1; peer review: awaiting peer review] Hope K. Matumaini https://orcid.org/0009-0000-7276-7196 1,2 , Innocent B. Mboya https://orcid.org/0000-0001-9861-5879 3,4 , Margaretha Sariko 5 , [...] Mshangama J. Seif 2 , Alex Mremi https://orcid.org/0000-0001-7226-0168 6 , Abdul-Hamid Lukambagire 7 , Sia E. Msuya 3,8 , Blandina Theophil Mmbaga https://orcid.org/0000-0002-5550-1916 5,9 , Louis Pisters 10 , Alfred K. Mteta 2,11 Hope K. Matumaini https://orcid.org/0009-0000-7276-7196 1,2 , Innocent B. Mboya https://orcid.org/0000-0001-9861-5879 3,4 , [...] Margaretha Sariko 5 , Mshangama J. Seif 2 , Alex Mremi https://orcid.org/0000-0001-7226-0168 6 , Abdul-Hamid Lukambagire 7 , Sia E. Msuya 3,8 , Blandina Theophil Mmbaga https://orcid.org/0000-0002-5550-1916 5,9 , Louis Pisters 10 , Alfred K. Mteta 2,11 PUBLISHED 02 Oct 2024 Author details Author details 1 Department of Urology, Mulago National Referral Hospital, Kampala, Uganda 2 Department of Urology, Kilimanjaro Christian Medical Centre, Moshi Urban, Kilimanjaro Region, Tanzania 3 Department of Epidemiology and Biostatistics, Institute of Public Health, Kilimanjaro Christian Medical University College, Moshi Urban, Kilimanjaro Region, Tanzania 4 Africa Academy for Public Health, Dar es Salaam, Dar es Salaam, Tanzania 5 Kilimanjaro Clinical Research Institute, Moshi, Tanzania 6 Department of Pathology, Kilimanjaro Christian Medical University College, Moshi Urban, Kilimanjaro Region, Tanzania 7 Department of Medical Parasitology and Entomology, Kilimanjaro Christian Medical University College, Moshi Urban, Kilimanjaro Region, Tanzania 8 Department of Community Health, Kilimanjaro Christian Medical Centre, Moshi Urban, Kilimanjaro Region, Tanzania 9 Department of Paediatrics and Child Health, Faculty of Medicine, Kilimanjaro Christian Medical University College, Moshi Urban, Kilimanjaro Region, Tanzania 10 Department of Urology Houston, UT MD Anderson Cancer Centre, Texas, USA 11 Department of Urology, Faculty of Medicine, Kilimanjaro Christian Medical University College, Moshi Urban, Kilimanjaro Region, Tanzania Hope K. Matumaini Roles: Conceptualization, Data Curation, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Innocent B. Mboya Roles: Methodology, Project Administration, Resources, Validation, Writing – Review & Editing Margaretha Sariko Roles: Data Curation, Methodology, Project Administration, Resources, Writing – Review & Editing Mshangama J. Seif Roles: Data Curation, Methodology, Project Administration, Resources, Writing – Review & Editing Alex Mremi Roles: Data Curation, Methodology, Project Administration, Resources, Writing – Review & Editing Abdul-Hamid Lukambagire Roles: Data Curation, Methodology, Project Administration, Resources, Writing – Review & Editing Sia E. Msuya Roles: Conceptualization, Methodology, Project Administration, Resources, Supervision, Writing – Review & Editing Blandina Theophil Mmbaga Roles: Conceptualization, Methodology, Project Administration, Resources, Supervision, Writing – Review & Editing Louis Pisters Roles: Methodology, Project Administration, Resources, Supervision, Validation, Writing – Review & Editing Alfred K. Mteta Roles: Conceptualization, Data Curation, Funding Acquisition, Methodology, Project Administration, Resources, Supervision, Validation, Writing – Review & Editing OPEN PEER REVIEW REVIEWER STATUS AWAITING PEER REVIEW This article is included in the Oncology gateway. Abstract Background Prostate cancer (PCa) is the most common cancer and the fifth leading cause of death in men worldwide. The treatment of PCa depends on the clinical stage of the disease, prostate-specific antigen (PSA) level, and histology. Lycopene is a bright red carotenoid found in tomatoes, which enhances apoptosis in prostate cells, but its effectiveness has not been studied in East African countries. This study aimed to determine the effectiveness of lycopene from tomato extracts in reducing PSA levels, disease progression, and apoptosis in the prostate glands of men with PCa in Tanzania. Methods This study will be a randomized phase III clinical trial of men diagnosed with PCa in Tanzania. In total, 400 men will be randomized in a 1:1 ratio to receive intervention (n=200) and control (n=200) and followed for 12 months. The intervention arm will receive tomato paste for daily use in addition to the standard treatment, whereas the control arm will only follow the standard of care. The primary endpoints will be a reduction in PSA levels, improved clinical status, and apoptosis of the prostate gland. Data analysis was performed based on the intention-to-treat principle. Descriptive statistics were used to compare average lycopene and PSA levels in the intervention group using T-test and Chi-squared tests. Generalized linear mixed models will be used to further assess the effect of lycopene on PCa progression, urinary symptoms, and PSA reduction. All statistical tests were two-sided at an alpha level of <0.05. Discussion The study used a food supplement as a drug/intervention with minimal or no adverse reactions. However, there is a fear that the control group may not adhere to the protocol after learning the benefits of tomato paste. The study findings will promote the consumption of tomato paste in males diagnosed with PCa to improve the clinical status and reduce disease progression. Trial registration The study has been registered at the Pan African Clinical Trial Registry with registration No PACTR202405488763956. READ ALL READ LESS Keywords Prostate cancer, PSA, Lycopene, tomato paste, Tanzania Corresponding Author(s) Hope K. Matumaini ( [email protected] ) Close Corresponding author: Hope K. Matumaini Competing interests: No competing interests were disclosed. Grant information: The study is funded through the Government of Uganda. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright: © 2024 Matumaini HK et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Matumaini HK, Mboya IB, Sariko M et al. Effect of lycopene on prostate cancer among native African men: A protocol for an open-label randomized clinical trial in Tanzania [version 1; peer review: awaiting peer review] . F1000Research 2024, 13 :1114 ( https://doi.org/10.12688/f1000research.156203.1 ) First published: 02 Oct 2024, 13 :1114 ( https://doi.org/10.12688/f1000research.156203.1 ) Latest published: 02 Oct 2024, 13 :1114 ( https://doi.org/10.12688/f1000research.156203.1 ) Introduction Prostate cancer (PCa) commonly affects men aged 50 years and above. 1 It is the fifth most common malignancy in men, accounting for up to 15% of all deaths. 2 , 3 PCa is the second leading cause of mortality in lung cancer patients. 4 According to Global Cancer Statistics, in 2020, PCa contributed up to 7.3% of all cancer cases worldwide. 5 In Africa, the WHO has estimated an incidence of 4%, with 300 cases per 100,000 men in Nigeria, and 39.2 per 100,000 men in Uganda. 6 In Tanzania, PCa is common among men after esophageal cancer, accounting for 3533 cases per year in 2020. 7 The cause of prostate cancer is unknown, but common risk factors are age, family history/genetic predisposition, diet, and race. 2 Saturated fats and refined carbohydrates are thought to negatively affect PCa risk in all races. 4 This is due to changes in the insulin-like growth factor pathway, androgen signalling, alterations in cell proliferation, and angiogenesis. The symptoms of PCa consist of lower urinary tract symptoms that interfere with urine flow, including urine frequency, urgency, nocturia, weak stream, incontinence, straining, and feeling of incomplete bladder emptying. 8 The diagnosis is often based on prostate-specific antigen (PSA) levels, clinical assessment including digital rectal examination (DRE), and histopathology from a trucut biopsy of the prostate gland. 8 , 9 Staging of prostate cancer is critical for prognosis assessment and treatment planning, for which the Tumor Node Metastasis (TNM) staging system 10 is commonly used. Treatment in men with a confirmed diagnosis depends on the clinical stage of the disease, PSA level, and histological findings. These indicators form the risk stratification for PCa into low-risk (PSA ≤10 ng/ml, TNM staging T1/T2a, Gleason score 20 ng/ml, TNM T3a, Gleason score 8-10). 11 Active surveillance is offered for low-risk patients, with curative intent interventions given to those in the intermediate risk, watchful waiting to those with high risk, and palliative care, including hormonal manipulation by medical or surgical castration. However, even for those who have been offered radical treatment, recovery is accompanied by many complications including urinary incontinence (60%) and erectile dysfunction (40%). 12 PSA is an important biomarker used to monitor treatment outcomes, 13 and is a bright red carotenoid pigment found in tomatoes, watermelon, and grapefruits. 4 It has an antioxidant effect that enhances apoptosis in prostate cells. 14 , 15 Previous studies have reported that lycopene in tomatoes plays a role in PCa prevention. 3 Processed tomatoes are easily absorbed by their bodies. Processed tomatoes have a higher amount of lycopene, that is, 100 g of tomato paste contains 13 mg lycopene, whereas 100 g of fresh tomato contains 7 mg lycopene. 10 Lycopene is beneficial in preventing the progression of PCa 16 through suppressing carcinogen-phosphorylation of P53 and other tumor suppressor genes, preventing, the deregulation of these proteins. 14 It also stops cellular division at the G0-G1 stage of the cell cycle, which prevents new tumors from becoming aggressive due to uncontrolled division. 14 However, challenges still exist in PCa control among African men. In this randomized controlled trial, we aimed to determine the efficacy of lycopene from tomato extracts in reducing PSA levels, disease progression, and apoptosis in the prostate gland of men with PCa in Tanzania. Protocol Study design and setting This study will be a randomized phase III clinical trial of men diagnosed with PCa in Tanzania. The study will be conducted at two tertiary care facilities: the Kilimanjaro Christian Medical Center (KCMC) in Moshi, northern Tanzania, and the Ocean Road Cancer Institute (ORCI) in Dar es Salaam, Eastern Tanzania. KCMC is a tertiary, referral, and teaching hospital with a 640-bed capacity that provides medical services to a population of 15.7 million people and receives 268 patients with PCa per year. 17 ORCI is the National Cancer Treatment Center for Tanzania, which receives patients from different parts of the country, with a bed capacity of 270 patients. Interventions The intervention arm will include PCa patients on standard treatment, such as radical prostatectomy or radical radiotherapy, and hormonal manipulation such as bilateral total orchidectomy, medical castration, or chemotherapy for advanced disease, in addition to tomato paste as an intervention. During clinic attendance, these men will be asked to take one sachet (60 g of tomato paste) daily. The tomato paste will be locally purchased, produced by a licenced Redgold factory in the Arusha region, northern Tanzania, and verified and certified by the Tanzania Food and Drug Authorities. Tomato paste consumption will be evaluated on three consecutive visits: three, six, and 12 months after randomization. The baseline serum concentration of lycopene was measured at the Kilimanjaro Clinical Research Institute (KCRI) laboratory in Tanzania. The Men will be asked to consume tomato paste either alone or mixed with food and not cooked to avoid exposure to more heat. The control arm will receive standard treatment according to national guidelines. Study population The sample size was calculated using the following formula for comparison of means between the two groups: 2 SD 2 ( Z a / 2 + Z b ) 2 / d 2 . 18 The study will enroll 400 men diagnosed with prostate cancer, confirmed by histopathology, with PSA of 4 ng/ml or greater, attending KCMC and ORCI, and will provide informed consent. Men will be randomized in a 1:1 ratio using computer-generated allocation, seal envelope approach to receive an intervention (200 men) and a control/standard treatment (200 men), equally allocated across sites, and followed for 12 months, taking equal numbers at each site. The randomization will be performed by an experienced clinical trial statistician and allocation performed by trained residents of the study team from the two study sites. The study will exclude patients with chronic gastrointestinal (GI) symptoms, since the study involves ingestion of a nutrient, malabsorption, diarrhea, allergy to tomato products, and critically ill patients. Standard operating procedures At baseline, consenting participants will be screened for demographic and clinical characteristics, total PSA, serum lycopene, and histopathology. PCa staging will be performed using digital rectal examination, assessment of symptoms, and physical examination. The Gleason scores for the level of apoptosis were determined by a pathologist. Trained clinicians will collect data using a questionnaire. Follow-up will be done at three, six and 12 months for the assessment of PSA, urinary symptoms, quality of life, and experience with tomato paste consumption. Histopathological examination was performed to examine and quantify apoptosis in the prostate gland before and after lycopene therapy. Reduction in PSA level, assessment of disease progression by ECOG, and Gleason score will also be measured at each visit. At each visit, we will examine serum lycopene, PSA, and clinical evaluations, such as blood pressure and physical examination, to assess comorbidities except for a trucut biopsy, which will be repeated after one year for histopathology. A dose of 48 mg lycopene/100 g of tomato paste has been documented elsewhere 19 ; however, we tested the concentration of lycopene in our local tomato paste. Measures PSA levels will be tested using the MAGLUMI 2000 Snibe Diagnostic tool from ABBOTT AIDD Longford, Ireland. The reaction was tested using a MAGLUMI total PSA chemiluminescence immunoassay (CLIA) cartridge containing magnetic microbeads, high and low calibrators buffer (ABEI Label), and diluent. To ensure proper test performance, we strictly adhered to the operating instructions of the fully auto-CLIA analyzer MAGLUMI. Each test parameter was identified via an RFID tag on the Reagent Integral. We used 300ul of serum sample in the sample chamber. The PSA results will be reported in terms of concentration (ng/ml). Samples with concentrations above the measurement range were diluted manually or using an analyzer. After manual dilution, the result was multiplied by the dilution factor. The analyzer software then automatically considered the dilution when calculating the sample concentration. The central focus of this study was to examine serum lycopene levels using UV-high-performance Liquid Chromatography (HPLC) analysis. This method entails the extraction of lycopene from serum using the protein crushing technique, employing ethanol, ascorbic acid, and hexane. The subsequent analysis will be conducted under isocratic conditions using the 3000 Ultimate Dionex and a C18 column (Hypersil 5-19626:150 × 4.6 mm i.d., 5 μm particle) 20 , 21 within the facilities of the KCRI-biotechnology laboratory. At 12 months, a trucut biopsy was repeated for histological evaluation by a pathologist, focusing on Gleason’s score to assess disease progression. Additionally, mobile phone follow-ups will be conducted weekly to assess whether participants are taking the tomato paste (intervention) or following the standard treatment, have experienced complications, and assess the overall improvement of their health. Any reported adverse effects will be recorded in the adverse effect report form at each visit and any phone call follow-ups. Data collection Trained resident doctors collected data using a structured questionnaire with the REDCap software. The tool will be in English and will be administered in Kiswahili, the local language. At each visit, 5 mls of venous blood was collected from participants for PSA and serum lycopene testing. Clinical assessment will be performed to assess urinary symptoms, experience with tomato consumption, and quality of life. The study will refund transport fares for all study participants. All information about the participants will be kept confidential and accessible only to the trial team. The trial committee will be responsible for checking the protocol for its completeness. The trial sponsor is responsible for auditing the trial. Data analysis Data cleaning and analysis were performed using the Stata version 15 software. Data analysis was performed based on the intention to treat (ITT) principle. Descriptive statistics were used to compare average lycopene and PSA levels in the intervention group using T-test and Chi-squared tests. Generalized linear mixed models will further assess the effects of lycopene on PCa progression, urinary symptoms, and PSA reduction. Model performance will be assessed using the Akaike Information Criteria, and all analyses will be assessed at a 5% threshold level. Multiple imputation techniques were used for the analysis of missing data. All statistical tests were two-sided at an alpha level of 50 years with unknown etiology, and treatment is multifactorial. Lycopene has the potential to slow PCa progression, and it is found in large amounts in tomato paste. This study demonstrates the efficacy of lycopene versus standard treatment in African men with PCa to advocate tomato paste consumption to prevent disease and improve clinical outcomes. The findings will be disseminated to the participants, KCMC and ORCI hospitals, peer-reviewed journals, and local libraries. Author contributions Matumaini H: Conceptualization, Data Curation, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Writing – Original Draft Preparation, Writing – Review & Editing; Mboya I: Methodology, Project Administration, Resources, Validation, Writing – Review & Editing; Sariko M: Data Curation, Methodology, Project Administration, Resources, Writing – Review & Editing; Seif M: Data Curation, Methodology, Project Administration, Resources, Writing – Review & Editing; Mremi A: Data Curation, Methodology, Project Administration, Resources, Writing – Review & Editing; Lukambagire A: Data Curation, Methodology, Project Administration, Resources, Writing – Review & Editing; Msuya S: Conceptualization; Methodology, Project Administration, Resources, Supervision, Validation, Writing – Review & Editing; Mmbaga B: Conceptualization; Methodology, Project Administration, Resources, Supervision, Validation, Writing – Review & Editing; Pisters L: Methodology, Project Administration, Resources, Supervision, Validation, Writing – Review & Editing; Mteta A: Conceptualization, Data Curation, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing. Ethics and consent The study was approved by the ethical review committees of the Kilimanjaro Christian Medical University College (approval number PG/2567), 10 th May 2022, and the National Institute for Medical Research (NIMR) (approval number NIMR/HQ/R8a/Vol.IX/4149), 19 th April 2024. The amendments will be handled by the same ethical review board. Written informed consent will be obtained from all study participants by the trained residents. Data availability statement Underlying data No data are associated with this article. Extended data Mendeley Data V1. Effect of lycopene on prostate cancer among native African men: A protocol for an open-label randomized clinical trial in Tanzania. doi: 10.17632/58pf3xrc8f.2 ( https://data.mendeley.com/datasets/58pf3xrc8f/2 ). 22 The project contains the following extended data: • Data Collection Tools - Lycopene Prostate Cancer Trial in Tanzania. Data are available under the terms of the Creative Commons Attribution 4.0 International licence (CC-BY 4.0). Reporting guidelines Mendeley Data V1. SPIRIT reporting guidelines for Effect of lycopene on prostate cancer among native African men: A protocol for an open-label randomized clinical trial in Tanzania. doi: 10.17632/58pf3xrc8f.2 ( https://data.mendeley.com/datasets/58pf3xrc8f/2 ). 22 Data are available under the terms of the Creative Commons Attribution 4.0 International licence (CC-BY 4.0). References 1. Huang TH, Kuo JY, Huang YH, et al. : Prostate cancer in young adults—Seventeen-year clinical experience of a single center. J. Chin. Med. Assoc. 2017; 80 (1): 39–43. Publisher Full Text 2. Boyle P, Severi G, Giles GG: The epidemiology of prostate cancer. Urol. Clin. N. Am. 2003; 30 : 209–217. Publisher Full Text 3. Soares ND, Elias MD, Machado CL, et al. : Comparative analysis of lycopene content from different tomato-based food products on the cellular activity of prostate cancer cell lines. Foods. 2019 Jun 10; 8 (6): 201. PubMed Abstract | Publisher Full Text | Free Full Text 4. Hori S, Butler E, McLoughlin J: Prostate cancer and diet: food for thought? BJU Int. 2011; 107 (9): 1348–1359. PubMed Abstract | Publisher Full Text 5. Nawi AM, Masdor NA, Othman R, et al. : Survival Rate and Prognostic Factors of Localised Prostate Cancer in Southeast Asian Countries: A Systematic Review with Meta-Analysis. Asian Pac. J. Cancer Prev. 2023; 24 : 2095–2941. PubMed Abstract | Publisher Full Text | Free Full Text 6. Nabunwa G, Mbwambo JS, Nyongole OV, et al. : Metabolic Syndrome in Patients on Androgen Deprivation Therapy for Prostate Cancer as seen at Kilimanjaro Christian Medical Center, Moshi, Tanzania. East Cent. Afr. J. Surg. 2014; 19 (2): 102–108. 7. Lyimo EP, Rumisha SF, Mremi IR, et al. : Cancer mortality patterns in Tanzania: A retrospective hospital-based study, 2006-2015. J. Glob. Oncol. 2020; 6 : 224–232. Publisher Full Text 8. Merriel SWD, Funston G, Hamilton W: Prostate Cancer in Primary Care. Adv. Ther. 2018; 35 (9): 1285–1294. PubMed Abstract | Publisher Full Text | Free Full Text 9. Mathaiyan DK, Tripathi SP, Raj JP, et al. : Histopathology, pharmacotherapy, and predictors of prostatic malignancy in elderly male patients with raised prostate-specific antigen levels–A prospective study. Urol. Ann. 2020 Apr 1; 12 (2): 132–137. PubMed Abstract | Publisher Full Text 10. Cheng L, Montironi R, Bostwick DG, et al. : Staging of prostate cancer. Histopathology. 2012 Jan; 60 (1): 87–117. Publisher Full Text 11. Preisser F, Cooperberg MR, Crook J, et al. : Intermediate-risk Prostate Cancer: Stratification and Management. Eur. Urol. Oncol. 2020; 3 (3): 270–280. Publisher Full Text 12. Radadia KD, Farber NJ, Shinder B, et al. : Management of Postradical Prostatectomy Urinary Incontinence: A Review. Urology. 2018; 113 : 13–19. PubMed Abstract | Publisher Full Text 13. Paur I, Lilleby W, Bøhn SK, et al. : Tomato-based randomized controlled trial in prostate cancer patients: Effect on PSA. Clin. Nutr. 2017; 36 (3): 672–679. PubMed Abstract | Publisher Full Text 14. Kotecha R, Takami A, Espinoza JL: Dietary phytochemicals and cancer chemoprevention: A review of the clinical evidence. Oncotarget. 2016; 7 (32): 52517–52529. PubMed Abstract | Publisher Full Text | Free Full Text 15. Edinger MS, Koff WJ: Effect of the consumption of tomato paste on plasma prostate-specific antigen levels in patients with benign prostate hyperplasia. Braz. J. Med. Biol. Res. 2006; 39 (8): 1115–1119. PubMed Abstract | Publisher Full Text 16. Kim HS, Bowen P, Chen L, et al. : Effects of tomato sauce consumption on apoptotic cell death in prostate benign hyperplasia and carcinoma. Nutr. Cancer. 2003 Sep 1; 47 (1): 40–47. PubMed Abstract | Publisher Full Text 17. Nyindo M, Lukambagire AH, Mimano L, et al. : Circulating Prostate Gland Cells in Benign Prostatic Hyperplasia and Adenocarcinoma in Patients of African Heritage: Diagnosis by Liquid Biopsy: Preliminary Results. J. Cancer Tumor Int. 2016; 4 (1): 1–11. Publisher Full Text 18. Charan J, Biswas T: How to calculate sample size for different study designs in medical research? Indian J. Psychol. Med. 2013; 35 (2): 121–126. PubMed Abstract | Publisher Full Text | Free Full Text 19. Zuorro A, Lavecchia R: Mild enzymatic method for the extraction of lycopene from tomato paste. Biotechnol. Biotechnol. Equip. 2010; 24 (2): 1854–1857. Publisher Full Text 20. Talwar D, Ha TKK, Cooney J, et al. : A routine method for the simultaneous measurement of retinol, α-tocopherol and five carotenoids in human plasma by reverse phase HPLC. Clin. Chim. Acta. 1998; 270 (2): 85–100. PubMed Abstract | Publisher Full Text 21. Tzeng MS, Lo YF, Wang-Hsu GS, et al. : Determination of major carotenoids in human serum by liquid chromatography. J. Food Drug Anal. 2004; 12 (1): 79–83. 22. Matumaini HK, Mboya I, Sariko M, et al. : Effect of lycopene on prostate cancer among native African men: A protocol for an open-label randomized clinical trial in Tanzania. Mendeley Data. 2024; V2 . 2024. Publisher Full Text Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 02 Oct 2024 ADD YOUR COMMENT Comment Author details Author details 1 Department of Urology, Mulago National Referral Hospital, Kampala, Uganda 2 Department of Urology, Kilimanjaro Christian Medical Centre, Moshi Urban, Kilimanjaro Region, Tanzania 3 Department of Epidemiology and Biostatistics, Institute of Public Health, Kilimanjaro Christian Medical University College, Moshi Urban, Kilimanjaro Region, Tanzania 4 Africa Academy for Public Health, Dar es Salaam, Dar es Salaam, Tanzania 5 Kilimanjaro Clinical Research Institute, Moshi, Tanzania 6 Department of Pathology, Kilimanjaro Christian Medical University College, Moshi Urban, Kilimanjaro Region, Tanzania 7 Department of Medical Parasitology and Entomology, Kilimanjaro Christian Medical University College, Moshi Urban, Kilimanjaro Region, Tanzania 8 Department of Community Health, Kilimanjaro Christian Medical Centre, Moshi Urban, Kilimanjaro Region, Tanzania 9 Department of Paediatrics and Child Health, Faculty of Medicine, Kilimanjaro Christian Medical University College, Moshi Urban, Kilimanjaro Region, Tanzania 10 Department of Urology Houston, UT MD Anderson Cancer Centre, Texas, USA 11 Department of Urology, Faculty of Medicine, Kilimanjaro Christian Medical University College, Moshi Urban, Kilimanjaro Region, Tanzania Hope K. Matumaini Roles: Conceptualization, Data Curation, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Innocent B. Mboya Roles: Methodology, Project Administration, Resources, Validation, Writing – Review & Editing Margaretha Sariko Roles: Data Curation, Methodology, Project Administration, Resources, Writing – Review & Editing Mshangama J. Seif Roles: Data Curation, Methodology, Project Administration, Resources, Writing – Review & Editing Alex Mremi Roles: Data Curation, Methodology, Project Administration, Resources, Writing – Review & Editing Abdul-Hamid Lukambagire Roles: Data Curation, Methodology, Project Administration, Resources, Writing – Review & Editing Sia E. Msuya Roles: Conceptualization, Methodology, Project Administration, Resources, Supervision, Writing – Review & Editing Blandina Theophil Mmbaga Roles: Conceptualization, Methodology, Project Administration, Resources, Supervision, Writing – Review & Editing Louis Pisters Roles: Methodology, Project Administration, Resources, Supervision, Validation, Writing – Review & Editing Alfred K. Mteta Roles: Conceptualization, Data Curation, Funding Acquisition, Methodology, Project Administration, Resources, Supervision, Validation, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information The study is funded through the Government of Uganda. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Article Versions (1) version 1 Published: 02 Oct 2024, 13:1114 https://doi.org/10.12688/f1000research.156203.1 Copyright © 2024 Matumaini HK et al . 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last seen: 2026-05-20T01:45:00.602351+00:00