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dc.contributor.authorNair-Shalliker, Visalini
dc.contributor.authorBang, Albert
dc.contributor.authorEgger, Sam
dc.contributor.authorRodger, Jennifer
dc.contributor.authorClements, Mark
dc.contributor.authorGardiner, Robert A
dc.contributor.authorKricker, Anne
dc.contributor.authorSeibel, Markus
dc.contributor.authorChambers, Suzanne K
dc.contributor.authorKimlin, Michael G
dc.contributor.authorArmstrong, Bruce K
dc.contributor.authorSmith, David P
dc.date.accessioned2020-05-19T22:30:48Z
dc.date.available2020-05-19T22:30:48Z
dc.date.issued2018
dc.identifier.issn1464-4096
dc.identifier.doi10.1111/bju.14474
dc.identifier.urihttp://hdl.handle.net/10072/394030
dc.description.abstractBackground: Active surveillance (AS) for prostate cancer (PC) patients with low risk of PC death is an alternative to radical treatment. Vitamin D supplementation may prevent PC progression. There is no evidence for its long‐term safety and efficacy, hence its use in the care of men with PC on AS needs assessment. Aim: Does vitamin D supplementation reduce the risk of PC progression in men with intermediate‐risk disease, during the first two years of AS? Population: PC cases aged between 50 and 75 years will have a: ● mpMRI (centrally reviewed, not limited to any PIRADS score) and ● Gleason score=7 (e.g. Gleason grade 3 + 4) or ● 2 positive biopsy core (which may include Gleason 6) or ● Clinical stage T2 (which may include Gleason 6) or ● PSA>10 ng/mL (which may include Gleason 6) All men with a histologically proven adenocarcinoma of the prostate will be randomised within 4 months of diagnosis. Study Design: A double‐blinded, placebo‐controlled randomized Phase II trial. Intervention: Men in the intervention arm will receive an initial loading dose of vitamin D supplementation (500,000 IU) followed by a monthly oral dose vitamin D supplementation (50,000 IU), while controls will receive a monthly oral placebo, for 2 years (24 months). Follow‐up: Each participant will be followed up: ● Monthly to determine trial compliance. ● 3 monthly for PSA levels and to monitor toxicity. ● At baseline, 12‐ and 24‐ months to collect blood specimens, tissue biopsy and have a mpMRI scan. Primary Endpoint: Active therapy‐free survival (ATFS), with no absolute requirements for conversion to ATFS. Trial Update: ProsD commenced recruitment in April 2017 and aims to recruit 120 men. Of the 29 men invited to participate, 26 consented and have been enrolled. Of these, two men have left the trial to seek curative treatment.
dc.languageEnglish
dc.publisherWiley
dc.relation.ispartofconferencename19th Asia-Pacific Prostate Cancer Conference
dc.relation.ispartofconferencetitleBju International
dc.relation.ispartofdatefrom2018-08-22
dc.relation.ispartofdateto2018-08-25
dc.relation.ispartoflocationBrisbane, Australia
dc.relation.ispartofpagefrom30
dc.relation.ispartofpageto31
dc.relation.ispartofissueS2
dc.relation.ispartofvolume122
dc.subject.fieldofresearchClinical Sciences
dc.subject.fieldofresearchcode1103
dc.subject.keywordsScience & Technology
dc.subject.keywordsLife Sciences & Biomedicine
dc.subject.keywordsUrology & Nephrology
dc.titleA phase II randomised control trial of high dose vitamin D in localised prostate cancer patients with intermediate risk of disease progression – ProsD Principal Investigator: Professor Howard Gurney
dc.typeConference output
dc.type.descriptionE3 - Conferences (Extract Paper)
dcterms.bibliographicCitationNair-Shalliker, V; Bang, A; Egger, S; Rodger, J; Clements, M; Gardiner, RA; Kricker, A; Seibel, M; Chambers, SK; Kimlin, MG; Armstrong, BK; Smith, DP, A phase II randomised control trial of high dose vitamin D in localised prostate cancer patients with intermediate risk of disease progression - ProsD Principal Investigator: Professor Howard Gurney, Bju International, 2018, 122, pp. 30-31
dc.date.updated2020-05-19T22:28:38Z
gro.hasfulltextNo Full Text
gro.griffith.authorChambers, Suzanne K.
gro.griffith.authorSmith, David


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