Can atorvastatin with metformin change the natural history of prostate cancer as characterized by molecular, metabolomic, imaging and pathological variables? A randomized controlled trial protocol.

Roberts, MJ; Yaxley, JW; Coughlin, GD; Gianduzzo, TRJ; Esler, RC; Dunglison, NT; Chambers, SK; Medcraft, RJ; Chow, CWK; Schirra, HJ; Richards, RS; Kienzle, N; Lu, M; Brereton, I; Samaratunga, H; Perry-Keene, J; Payton, D; Oyama, C; Doi, SA; Lavin, MF; Gardiner, RA

Can atorvastatin with metformin change the natural history of prostate cancer as characterized by molecular, metabolomic, imaging and pathological variables? A randomized controlled trial protocol.

Roberts, MJ Yaxley, JW Coughlin, GD Gianduzzo, TRJ Esler, RC Dunglison, NT Chambers, SK Medcraft, RJ Chow, CWK Schirra, HJ Richards, RS Kienzle, N Lu, M Brereton, I Samaratunga, H Perry-Keene, J Payton, D Oyama, C Doi, SA Lavin, MF Gardiner, RA

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Publisher:: ELSEVIER SCIENCE INC
Publication Type:: Journal Article
Citation:: Contemp Clin Trials, 2016, 50, pp. 16-20
Issue Date:: 2016-09

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Field	Value	Language
dc.contributor.author	Roberts, MJ
dc.contributor.author	Yaxley, JW
dc.contributor.author	Coughlin, GD
dc.contributor.author	Gianduzzo, TRJ
dc.contributor.author	Esler, RC
dc.contributor.author	Dunglison, NT
dc.contributor.author	Chambers, SK
dc.contributor.author	Medcraft, RJ
dc.contributor.author	Chow, CWK
dc.contributor.author	Schirra, HJ
dc.contributor.author	Richards, RS
dc.contributor.author	Kienzle, N
dc.contributor.author	Lu, M
dc.contributor.author	Brereton, I
dc.contributor.author	Samaratunga, H
dc.contributor.author	Perry-Keene, J
dc.contributor.author	Payton, D
dc.contributor.author	Oyama, C
dc.contributor.author	Doi, SA
dc.contributor.author	Lavin, MF
dc.contributor.author	Gardiner, RA
dc.date.accessioned	2022-08-03T04:52:45Z
dc.date.available	2016-06-26
dc.date.available	2022-08-03T04:52:45Z
dc.date.issued	2016-09
dc.identifier.citation	Contemp Clin Trials, 2016, 50, pp. 16-20
dc.identifier.issn	1551-7144
dc.identifier.issn	1559-2030
dc.identifier.uri	http://hdl.handle.net/10453/159555
dc.description.abstract	BACKGROUND: Atorvastatin and metformin are known energy restricting mimetic agents that act synergistically to produce molecular and metabolic changes in advanced prostate cancer (PCa). This trial seeks to determine whether these drugs favourably alter selected parameters in men with clinically-localized, aggressive PCa. METHODS/DESIGN: This prospective phase II randomized, controlled window trial is recruiting men with clinically significant PCa, confirmed by biopsy following multiparametric MRI and intending to undergo radical prostatectomy. Ethical approval was granted by the Royal Brisbane and Women's Hospital Human and The University of Queensland Medical Research Ethics Committees. Participants are being randomized into four groups: metformin with placebo; atorvastatin with placebo; metformin with atorvastatin; or placebo alone. Capsules are consumed for 8weeks, a duration selected as the most appropriate period in which histological and biochemical changes may be observed while allowing prompt treatment with curative intent of clinically significant PCa. At recruitment and prior to RP, participants provide blood, urine and seminal fluid. A subset of participants will undergo 7Tesla magnetic resonance spectroscopy to compare metabolites in-vivo with those in seminal fluid and biopsied tissue. The primary end point is biochemical evolution, defined using biomarkers (serum prostate specific antigen; PCA3 and citrate in seminal fluid and prostatic tissue). Standard pathological assessment will be undertaken. DISCUSSION: This study is designed to assess the potential synergistic action of metformin and atorvastatin on PCa tumour biology. The results may determine simple methods of tumour modulation to reduce disease progression.
dc.format	Print-Electronic
dc.language	eng
dc.publisher	ELSEVIER SCIENCE INC
dc.relation.ispartof	Contemp Clin Trials
dc.relation.isbasedon	10.1016/j.cct.2016.06.014
dc.rights	info:eu-repo/semantics/closedAccess
dc.subject	11 Medical and Health Sciences
dc.subject.classification	General Clinical Medicine
dc.subject.classification	Public Health
dc.subject.mesh	Antigens, Neoplasm
dc.subject.mesh	Atorvastatin
dc.subject.mesh	Biomarkers, Tumor
dc.subject.mesh	Citric Acid
dc.subject.mesh	Double-Blind Method
dc.subject.mesh	Drug Therapy, Combination
dc.subject.mesh	Humans
dc.subject.mesh	Male
dc.subject.mesh	Metformin
dc.subject.mesh	Prospective Studies
dc.subject.mesh	Prostate-Specific Antigen
dc.subject.mesh	Prostatic Neoplasms
dc.subject.mesh	Research Design
dc.subject.mesh	Humans
dc.subject.mesh	Prostatic Neoplasms
dc.subject.mesh	Metformin
dc.subject.mesh	Citric Acid
dc.subject.mesh	Prostate-Specific Antigen
dc.subject.mesh	Antigens, Neoplasm
dc.subject.mesh	Drug Therapy, Combination
dc.subject.mesh	Prospective Studies
dc.subject.mesh	Double-Blind Method
dc.subject.mesh	Research Design
dc.subject.mesh	Male
dc.subject.mesh	Biomarkers, Tumor
dc.subject.mesh	Atorvastatin
dc.title	Can atorvastatin with metformin change the natural history of prostate cancer as characterized by molecular, metabolomic, imaging and pathological variables? A randomized controlled trial protocol.
dc.type	Journal Article
utslib.citation.volume	50
utslib.location.activity	United States
utslib.for	11 Medical and Health Sciences
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
utslib.copyright.status	closed_access	*
dc.date.updated	2022-08-03T04:52:44Z
pubs.publication-status	Published
pubs.volume	50

Abstract:

BACKGROUND: Atorvastatin and metformin are known energy restricting mimetic agents that act synergistically to produce molecular and metabolic changes in advanced prostate cancer (PCa). This trial seeks to determine whether these drugs favourably alter selected parameters in men with clinically-localized, aggressive PCa. METHODS/DESIGN: This prospective phase II randomized, controlled window trial is recruiting men with clinically significant PCa, confirmed by biopsy following multiparametric MRI and intending to undergo radical prostatectomy. Ethical approval was granted by the Royal Brisbane and Women's Hospital Human and The University of Queensland Medical Research Ethics Committees. Participants are being randomized into four groups: metformin with placebo; atorvastatin with placebo; metformin with atorvastatin; or placebo alone. Capsules are consumed for 8weeks, a duration selected as the most appropriate period in which histological and biochemical changes may be observed while allowing prompt treatment with curative intent of clinically significant PCa. At recruitment and prior to RP, participants provide blood, urine and seminal fluid. A subset of participants will undergo 7Tesla magnetic resonance spectroscopy to compare metabolites in-vivo with those in seminal fluid and biopsied tissue. The primary end point is biochemical evolution, defined using biomarkers (serum prostate specific antigen; PCA3 and citrate in seminal fluid and prostatic tissue). Standard pathological assessment will be undertaken. DISCUSSION: This study is designed to assess the potential synergistic action of metformin and atorvastatin on PCa tumour biology. The results may determine simple methods of tumour modulation to reduce disease progression.

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http://hdl.handle.net/10453/159555