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
Journal article
Roberts, Matthew J., Yaxley, John W., Coughlin, Geoffrey D., Gianduzzo, Troy R. J., Esler, Rachel C., Dunglison, Nigel T., Chambers, Suzanne K., Medcraft, Robyn J., Chow, Clement W. K., Schirra, Horst Joachim, Richards, Renee S., Kienzle, Nicholas, Lu, Macy, Brereton, Ian, Samaratunga, Hema, Perry-Keene, Joanna, Payton, Diane, Oyama, Chikara, Doi, Suhail A., ... Gardiner, Robert A.. (2016). 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. Contemporary Clinical Trials. 50, pp. 16-20. https://doi.org/10.1016/j.cct.2016.06.014
Authors | Roberts, Matthew J., Yaxley, John W., Coughlin, Geoffrey D., Gianduzzo, Troy R. J., Esler, Rachel C., Dunglison, Nigel T., Chambers, Suzanne K., Medcraft, Robyn J., Chow, Clement W. K., Schirra, Horst Joachim, Richards, Renee S., Kienzle, Nicholas, Lu, Macy, Brereton, Ian, Samaratunga, Hema, Perry-Keene, Joanna, Payton, Diane, Oyama, Chikara, Doi, Suhail A., Lavin, Martin F. and Gardiner, Robert A. |
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Abstract | Background Methods/design Participants are being randomized into four groups: metformin with placebo; atorvastatin with placebo; metformin with atorvastatin; or placebo alone. Capsules are consumed for 8 weeks, 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 |
Keywords | prostate cancer; atorvastatin; metformin; clinical trial; biomarkers; metabolomics |
Year | 2016 |
Journal | Contemporary Clinical Trials |
Journal citation | 50, pp. 16-20 |
Publisher | Elsevier Inc. |
ISSN | 1551-7144 |
Digital Object Identifier (DOI) | https://doi.org/10.1016/j.cct.2016.06.014 |
PubMed ID | 27370230 |
Scopus EID | 2-s2.0-84978698686 |
Research or scholarly | Research |
Page range | 16-20 |
Publisher's version | License All rights reserved File Access Level Controlled |
Output status | Published |
Publication dates | |
Online | 28 Jun 2016 |
Publication process dates | |
Accepted | 26 Jun 2016 |
Deposited | 11 Nov 2021 |
https://acuresearchbank.acu.edu.au/item/8x07q/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
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