High-dose vitamin D supplementation to prevent prostate cancer progression in localised cases with low-to-intermediate risk of progression on active surveillance (ProsD): protocol of a phase II randomised controlled trial
Val Gebski,
Henry Woo,
Howard Gurney,
Bruce K Armstrong,
David P Smith,
Visalini Nair-Shalliker,
Manish I Patel,
Mark Frydenberg,
John W Yaxley,
Robert Gardiner,
David Espinoza,
Michael G Kimlin,
Michael Fenech,
David Gillatt,
Krishan Rasiah,
Nader Awad,
James Symons
Affiliations
Val Gebski
3University of Sydney, Nhmrc Clinical Trial Centre, Sydney, Australia
Henry Woo
Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia
Howard Gurney
Department of Medical Oncology, Westmead Hospital, Sydney, New South Wales, Australia
Bruce K Armstrong
School of Public Health, The University of Western Australia, Perth, Western Australia, Australia
David P Smith
Cancer Epidemiology Research Unit, Cancer Council New South Wales, Sydney, Australia
Visalini Nair-Shalliker
Cancer Research Division, Cancer Council New South Wales, Woolloomooloo, New South Wales, Australia
Manish I Patel
Discipline of Surgery, The University of Sydney, Sydney, Australia
Mark Frydenberg
Department of Surgery, Cabrini Institute, Cabrini Health, Monash University Faculty of Medicine, Nursing and Health Sciences, Melbourne, Victoria, Australia
John W Yaxley
Centre for Clinical Research, The University of Queensland, Saint Lucia, Queensland, Australia
Robert Gardiner
Centre for Clinical Research, The University of Queensland, Saint Lucia, Queensland, Australia
David Espinoza
Clinical Trials Center, The University of Sydney, Sydney, New South Wales, Australia
Michael G Kimlin
Faculty of Health, Queensland University of Technology, Brisbane, Queensland, Australia
Michael Fenech
Clinical and Health Sciences, University of South Australia, Adelaide, South Australia, Australia
David Gillatt
MQ Health, Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, New South Wales, Australia
Krishan Rasiah
Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia
Nader Awad
Urology Centre, Port Macquarie, New South Wales, Australia
James Symons
Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia
Introduction Active surveillance (AS) for patients with prostate cancer (PC) with low risk of PC death is an alternative to radical treatment. A major drawback of AS is the uncertainty whether a patient truly has low risk PC based on biopsy alone. Multiparametric MRI scan together with biopsy, appears useful in separating patients who need curative therapy from those for whom AS may be safe. Two small clinical trials have shown short-term high-dose vitamin D supplementation may prevent PC progression. There is no substantial evidence for its long-term safety and efficacy, hence its use in the care of men with PC on AS needs assessment. This protocol describes the ProsD clinical trial which aims to determine if oral high-dose vitamin D supplementation taken monthly for 2 years can prevent PC progression in cases with low-to-intermediate risk of progression.Method and analysis This is an Australian national multicentre, 2:1 double-blinded placebo-controlled phase II randomised controlled trial of monthly oral high-dose vitamin D supplementation (50 000 IU cholecalciferol), in men diagnosed with localised PC who have low-to-intermediate risk of disease progression and are being managed by AS. This trial will assess the feasibility, efficacy and safety of supplementing men with an initial oral loading dose of 500 000 IU cholecalciferol, followed by a monthly oral dose of 50 000 IU during the 24 months of AS. The primary trial outcome is the commencement of active therapy for clinical or non-clinical reason, within 2 years of AS.Ethics and dissemination This trial is approved by Bellberry Ethics Committee (2016-06-459). All results will be reported in peer-reviewed journals.Trial registration number ACTRN12616001707459.