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How much vitamin D should you take for prostate cancer?

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Follow-up is 2 years and therefore a benefit or lack of benefit of vitamin D may not be appreciated in this time, given the natural slow progression of prostate cancer, is a limitation. This is a phase 2 trial, hence results will not be conclusive for the role of vitamin D but may inform a phase 3 trial, is a limitation.

Introduction

Prostate cancer (PC) affects many men worldwide, with 1 276 106 new cases and 358 989 deaths estimated for 2018.1 2 The proportion of low-risk tumours diagnosed has risen since the introduction of prostate-specific antigen (PSA) testing, leading in some cases to overdiagnosis, adverse effects and unnecessary treatment.3 Over diagnosis due to PSA-testing may be unavoidable, but overtreatment is not. Results from the prostate testing for cancer and treatment suggest minimal benefits in men with low-risk PC when managed with curative treatment, and instead recommended monitoring the course of PC with the intention of initiating curative treatment if and when the cancer progresses. Referred to as active surveillance (AS), this management option has evolved as an alternative to immediate active treatment for those diagnosed with low grade disease.4 Consequently, AS is now the preferred management strategy for most men with low-risk PC. It aims to avoid overtreatment of clinically indolent disease by safely delaying definitive treatment until evidence of progression is evident. The following augmented risk classification for low, intermediate and high-risk groups is used as guide to classify disease status5–7: Low risk: PSA <10 ng/mL, and Gleason 3+3 or less, 2 or less positive biopsy cores and clinical stage T1–T2a. Intermediate: PSA 10 to <20 ng/mL or Gleason 7 (Gleason 3+4 or Gleason 4+3) or clinical stage T2b-c subdivided into: Favourable risk: Gleason 3+3 (with PSA 10 to <20 ng/mL or T2b-c) or Gleason 3+4. Non-favourable risk: Gleason 3+4 (with PSA 10 to <20 ng/mL or T2b-c) or Gleason 4+3. High-risk: PSA >20 ng/mL, or Gleason 8 or greater, or clinical stage >T3. The preferred management strategy that is widely adopted for most men with low-risk disease is AS while curative/active treatment is widely adopted for men with intermediate to high risk disease .8–11 There is mounting evidence that men with favourable intermediate risk PC may have similar mortality risk as those with low-risk disease. These men may, therefore, be good candidates for AS, as a safe first-line management option, although the consensus to accurately define this subgroup of PC cases needs clarity.4 8–12 Prostate cancer diagnosis PC is conventionally diagnosed using transrectal ultrasound to guide prostate biopsy (PB). As cancer cannot be imaged on ultrasound, the major limitation of this approach is non-detection of a substantial proportion of significant PC. Sampling error can lead to the misdiagnosis of clinically significant disease, which may be upgraded at repeat biopsy. Referred to as reclassification, this gives the perception of disease progression, subsequently leading to overtreatment. The Prostate Cancer Research International Active Surveillance Project, referred to as the PRIAS Project estimated that approximately 28% of PRIAS participants showed reclassification on repeat biopsy.13–15 The use of multiparametric MRI (mpMRI), originally used for staging, is now routinely used for tumour detection and localisation, allowing image-guided targeted sampling to overcome the limitations of the traditional blind PB. mpMRI is able to detect both high-grade and larger tumours accurately, which means it may perform particularly well for detection of clinically significant disease.16–18 It can improve the specificity of locating PC and targeting the PB. It can also differentiate low- and intermediate/high-grade PC, thereby providing more accurate risk classification of PC.

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Prostate cancer risk and vitamin D Two recent clinical trials in PC patients suggest that vitamin D supplementation may prevent PC progression.19 20 Daily supplementation of 4000 IU for 1 year reduced the number of positive cores and Gleason grade, but did not reduce PSA levels.19 A daily high dose of 40 000 IU for only 10 weeks significantly reduced PSA levels but did not change Ki67 expression in prostate tissue. Those who received 4000 IU and 10 000 IU showed no significant reduction in PSA level.20 Duration of follow-up was short in both these trials and may have resulted in the lack of significant findings. Further trials of high vitamin D doses to prevent PC progression are therefore required. Trials are also needed to assess the long-term safety of vitamin D supplementation in patients with cancer. Prostate cancer and genome damage There is a strong link between the prevalence of markers of genome damage and cancer risk. Studies have shown that prevalence of chromosomal aberrations is 2.2-fold to 2.4-fold higher in cancer patients than in non-cancer controls, and that micronuclei (MN) formation, a marker for chromosomal instability, was associated with increased cancer incidence in a study of 6718 individuals.21 There is also evidence to link telomeres to cancer risk.22 Telomeres are repetitive TTAGGG DNA sequences that maintain genomic stability by protecting the ends of chromosomes; they shorten in length over time in normal somatic tissues due to incomplete replication of the telomere. Telomere shortening is accelerated by oxidative stress, inflammation and cell proliferation and has been linked with induction of cell senescence which guards against survival of genomically abnormal cells.23 Evidence from prospective studies show positive associations between telomere length and various cancers, including that for low-grade (OR 1.13, 95% CI 1.01 to 1.27) and localised PC (OR 1.12, 95% CI 1.01 to 1.24) disease, possibly due to abnormal telomerase expression and telomere elongation, which enables the survival of genomically unstable cells, their unrestricted growth and their evolution into cancer.24–26 There is evidence to show that some micronutrients are essential to prevent genome damage but the specific impact of vitamin D is only just starting to be explored.27 Evidence suggests that high levels of vitamin D metabolites (25(OH)D and 1,25(OH) 2 D) may prevent genome damage in leukocytes by reducing prevalence of MN formation and by maintaining adequate telomere length.28–32 There is also evidence to suggest that 1,25(OH) 2 D may inhibit telomerase activity in tumour tissue in a pathway involving miRNA498, a non-coding small RNA.33 This current trial provides an opportunity to concurrently examine the possible role of vitamin D in the regulation of these markers of DNA damage in PC. Rationale The ProsD study is a 2:1 double blinded placebo controlled randomised control trial (RCT) for high-dose vitamin D supplementation, in a group of men with PC who have low-to-intermediate risk of disease progression, and are undertaking AS. There is uncertainty as to whether AS or curative therapy is best for this risk group. The protocol mandates the use of MRI-detected and targeted cancers in the inclusion criteria to reduce disease reclassification bias due to sampling error on biopsy and to assist in the diagnosis of disease progression on AS.

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