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High-dose vitamin D supplementation and prostate cancer progression: a phase II randomised trial in localised prostate cancer cases with intermediate risk of progression (ProsD)

Sun, 01 Mar 2026 00:00:00 GMT

Title: High-dose vitamin D supplementation and prostate cancer progression: a phase II randomised trial in localised prostate cancer cases with intermediate risk of progression (ProsD) Authors: Nair-Shalliker, V.; Smith, D. P.; Gebski, V.; Patel, M. I.; Frydenberg, M.; Yaxley, J.; Gardiner, R.; Espinoza, D.; Kimlin, M. G.; Dhillon, V.; Leifert, W.; Gillatt, D.; Woo, H.; Rasiah, K.; Awad, Nader; Symons, J.; Wells, J. K.; Pickett, M.; French, M.; Anderson, P. H.; Armstrong, B. K.; Gurney, H. Abstract: Background The ProsD trial aimed to determine if oral vitamin D supplementation could prevent prostate cancer ( PC ) progression in men on active surveillance ( AS ). Methods ProsD is a phase-II double-blinded randomized trial of newly diagnosed, low-intermediate risk PC cases, aged between 50 and 80 years and on AS. The intervention was a monthly oral dose of cholecalciferol (50,000IU; Vitamin D) or placebo. Primary and secondary endpoints were active therapy-free ( ATFS ) and progression-free ( PFS ) survival, respectively. Blood samples were analysed for vitamin D metabolites and cytokinesis-block micronucleus cytome (CBMN) markers for lymphocytic genome damage. Results There were 123 randomised participants (81 vitamin D and 42 placebo) included in this analysis. Mean (SD) for age was 66.5 (6.6) years and for 25(OH)D levels were 72.0 (19.9) and 66.4 (18.4) nmol/L at baseline ( p = 0.1), and 91.9 (19.9) and 60.4 (24.4) nmol/L at 24 months, in the vitamin D and placebo arms respectively. There were no appreciable differences in ATFS (p log-rank = 0.44), PFS (p p log-rank = 0.60) and occurrence of adverse events, in each trial arm. There were declines in some of the lymphocytic CBMN markers in the vitamin D arm. Conclusion Vitamin D supplementation did not prevent PC progression, although reduced prevalence of CBMN markers may indicate a benefit of vitamin D supplementation. Trial registration Australia New Zealand Clinical Trials Registry (ACTRN12616001707459). Key points Findings: In this phase 2 randomised trial involving 123 prostate cancer patients with low-intermediate risk of progression, vitamin D supplementation did not prevent patients discontinuing active surveillance in favour of active therapy. However, vitamin D supplementation reduced prevalence of lymphocytic genome damage markers that are predictors of cancer risk. Meaning: Vitamin D supplementation may not prevent progression of well-developed prostate cancers, however reduction in the prevalence of lymphocytic genome damage in the vitamin D arm of the study suggests an anti-cancer effect that may prevent the initiation of new cancers.

Radiographic Progression Without Prostate-specific Antigen Progression in Metastatic Hormone-sensitive Prostate Cancer: A Retrospective Analysis of the ENZAMET Trial (ANZUP 1304)

Sun, 01 Feb 2026 00:00:00 GMT

Title: Radiographic Progression Without Prostate-specific Antigen Progression in Metastatic Hormone-sensitive Prostate Cancer: A Retrospective Analysis of the ENZAMET Trial (ANZUP 1304) Authors: Inderjeeth, A-J.; Martin, A.J.; Zielinski, R.R.; Begbie, S.; Cheung, L.; Chowdhury, S.; Frydenberg, M.; Horvath, L.G.; Joshua, A.M.; Lawrence, N.J.; Marx, G.; McCaffrey, J.; McDermott, R.S.; McJannett, M.; North, S.A.; Parnis, F.; Parulekar, W.R.; Pook, D.W.; Reaume, M.N.; Sandhu, S.; Tan, A.; Tan, T.H.; Thomson, A.H.; Vera-Badillo, F.; Williams, S.G.; Thomas, H.; Yip, S.; Zhang, A.Y.; Chi, K.N.; Stockler, M.R.; Sweeney, C.J.; Davis, I.D.; ENZAMET Trial Investigators and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group. Abstract: Background and objective: ENZAMET randomised 1125 participants with metastatic hormone-sensitive prostate cancer to receive enzalutamide or a standard nonsteroidal antiandrogen (NSAA) combined with testosterone suppression with or without docetaxel. Enzalutamide demonstrated superior progression-free and overall survival (OS). Radiographic progression without prior/concurrent prostate-specific antigen progression (discordant progression; DP) portends poor outcomes. Our aim was to determine the frequency of DP in ENZAMET and the impact of enzalutamide on disease-state transitions. Methods: A multistate Cox proportional-hazards regression model was used to partition participants into four states: (1) event-free; (2) discordant progression (DP); (3) other types of progression (other progression; OP); and (4) death. Key findings and limitations: Enzalutamide prolonged OS in the entire cohort of 1125 participants (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.58-0.84; p < 0.0001). Radiographic progression occurred in 388/1125 (34%) participants, and DP in 114/1125 (10%), with similar proportions in the enzalutamide arm (55/114, 48%) and NSAA arm (59/114, 52%). Participant characteristics in the DP group were similar between the treatment arms. Enzalutamide delayed DP (HR 0.66, 95% CI 0.46-0.96; p = 0.03) and OP (HR 0.37, 95% CI 0.31-0.44; p < 0.001). The 5-yr OS rate was lower in the DP group (24%) than in the OP group (42%). Among participants whose cancer had not progressed (495/1125), 51/495 (10%) died of non-prostate cancer causes (median follow-up 68 mo). This exploratory analysis is limited by its post hoc nature. Conclusions and clinical implications: DP occurred in 10% of participants and accounted for 30% of progression events observed in ENZAMET. DP was associated with worse OS regardless of treatment. Enzalutamide delayed DP and reduced the risk of DP and OP. Regularly scheduled imaging may be preferable to for-cause imaging in metastatic hormone-sensitive prostate cancer.

High-dose vitamin D supplementation and prostate cancer progression: a phase II randomised trial in localised prostate cancer cases with intermediate risk of progression (ProsD)

Sun, 01 Mar 2026 00:00:00 GMT

Title: High-dose vitamin D supplementation and prostate cancer progression: a phase II randomised trial in localised prostate cancer cases with intermediate risk of progression (ProsD) Authors: Nair-Shalliker, V.; Smith, D.P.; Gebski, V.; Patel, M.I.; Frydenberg, M.; Yaxley, J.; Gardiner, R.; Espinoza, D.; Kimlin, M.G.; Dhillon, V.; Leifert, W.; Gillatt, D.; Woo, H.; Rasiah, K.; Awad, N.; Symons, J.; Wells, J.K.; Pickett, H.A.; Fenech, M.; Anderson, P.H.; Armstrong, B.K.; Gurney, H. Abstract: Background: The ProsD trial aimed to determine if oral vitamin D supplementation could prevent prostate cancer (PC) progression in men on active surveillance (AS). Methods: ProsD is a phase-II double-blinded randomized trial of newly diagnosed, low-intermediate risk PC cases, aged between 50 and 80 years and on AS. The intervention was a monthly oral dose of cholecalciferol (50,000IU; Vitamin D) or placebo. Primary and secondary endpoints were active therapy-free (ATFS) and progression-free (PFS) survival, respectively. Blood samples were analysed for vitamin D metabolites and cytokinesis-block micronucleus cytome (CBMN) markers for lymphocytic genome damage. Results: There were 123 randomised participants (81 vitamin D and 42 placebo) included in this analysis. Mean (SD) for age was 66.5 (6.6) years and for 25(OH)D levels were 72.0 (19.9) and 66.4 (18.4) nmol/L at baseline (p = 0.1), and 91.9 (19.9) and 60.4 (24.4) nmol/L at 24 months, in the vitamin D and placebo arms respectively. There were no appreciable differences in ATFS (plog-rank = 0.44), PFS (p plog-rank = 0.60) and occurrence of adverse events, in each trial arm. There were declines in some of the lymphocytic CBMN markers in the vitamin D arm. Conclusion: Vitamin D supplementation did not prevent PC progression, although reduced prevalence of CBMN markers may indicate a benefit of vitamin D supplementation.

Definitive Chemoradiotherapy for Oesophageal Cancer: a Retrospective Institutional Review

Sat, 01 Nov 2025 00:00:00 GMT

Title: Definitive Chemoradiotherapy for Oesophageal Cancer: a Retrospective Institutional Review Authors: Freeman, Georgia; Lo, Helen; Last, Andrew; Roach, Ethan Abstract: Oesophageal cancer has high mortality, with currenttreatments often causing significant toxicity. Thisretrospective study compared outcomes of twochemoradiotherapy regimens: IV cisplatin withinfusional 5-fluorouracil (cis-5FU) versus IVcarboplatin with paclitaxel (carbo-taxol). Data frompatients treated definitively at the Mid North Coastand Northern NSW Cancer Institutes between 2017-2022 were analysed. All patients had a radiotherapydosage of greater than or equal to 50Gy, based onINT 0123, which found no benefit beyond 50.4 Gywith cis-5FU (1). The carbo-taxol regimen wasadapted from the CROSS trial (2). Although not testedas definitive therapy, it is often used due to lowertoxicity and favourable response rates.Of the 172 patients, 44 received cis-5FU and 128received carbo-taxol. Histological subtypes were:41% squamous cell carcinoma (SCC), 58%adenocarcinoma, 1% mixed. Three-year overallsurvival (OS) was 30.8% with cis-5FU and 19% withcarbo-taxol. Across the cohort, 3-year OS was 30.3%in SCC and 17.6% in adenocarcinoma. Theseinstitutional results are consistent with publisheddata, with better outcomes in SCC and with cis-5FU.This is the largest Australian cohort evaluatingdefinitive chemoradiotherapy in oesophagealcancer.Acute and long-term toxicities are currently beinganalysed and will be presented in the final poster.