Predictive fActors for toleraNce to Taxane Based CHemotherapy In Older adultS Affected by mEtastatic Prostate Cancer
ANCHISES
1 other identifier
observational
118
1 country
1
Brief Summary
Aiming to explore predictive factors of fitness to taxane chemotherapy in elderly patients, the investigators collected data from a prospective mono-centric database of patients aged \>/= 70 years old treated in our department, and explored association between baseline age, G8 score and Charlson comorbidity index with taxane dose reduction, treatment temporary suspension or definitive interruption.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedFirst Submitted
Initial submission to the registry
July 8, 2022
CompletedFirst Posted
Study publicly available on registry
July 22, 2022
CompletedJuly 22, 2022
July 1, 2022
2.5 years
July 8, 2022
July 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment interruption
Number of participants with definitive treatment stop unrelated to treatment progression
10 months
Secondary Outcomes (1)
Treatment suspension
10 months
Other Outcomes (1)
Dose reduction
10 months
Interventions
Patients underwent taxane chemotherapy according to clinical practice for metastatic prostate cancer
Eligibility Criteria
Patients affected by metastatic prostate cancer (either in castrate resistant or hormone sensitive status), undergoing taxane chemotherapy in any setting at an age \>/=70 years old
You may qualify if:
- Patients affected by metastatic prostate cancer
- \>/=70 years old.
- Patients undergoing Taxane treatment with Docetaxel or Cabazitaxel
You may not qualify if:
- Patients younger than 70 years old.
- Patients unsuitable for taxane chemotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AOU Careggi Radiation Oncology Unit
Florence, 50134, Italy
Related Publications (19)
Berthold DR, Pond GR, Soban F, de Wit R, Eisenberger M, Tannock IF. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: updated survival in the TAX 327 study. J Clin Oncol. 2008 Jan 10;26(2):242-5. doi: 10.1200/JCO.2007.12.4008.
PMID: 18182665BACKGROUNDde Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, Gravis G, Bodrogi I, Mackenzie MJ, Shen L, Roessner M, Gupta S, Sartor AO; TROPIC Investigators. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010 Oct 2;376(9747):1147-54. doi: 10.1016/S0140-6736(10)61389-X.
PMID: 20888992BACKGROUNDKyriakopoulos CE, Chen YH, Carducci MA, Liu G, Jarrard DF, Hahn NM, Shevrin DH, Dreicer R, Hussain M, Eisenberger M, Kohli M, Plimack ER, Vogelzang NJ, Picus J, Cooney MM, Garcia JA, DiPaola RS, Sweeney CJ. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer: Long-Term Survival Analysis of the Randomized Phase III E3805 CHAARTED Trial. J Clin Oncol. 2018 Apr 10;36(11):1080-1087. doi: 10.1200/JCO.2017.75.3657. Epub 2018 Jan 31.
PMID: 29384722BACKGROUNDJames ND, Sydes MR, Clarke NW, Mason MD, Dearnaley DP, Spears MR, Ritchie AW, Parker CC, Russell JM, Attard G, de Bono J, Cross W, Jones RJ, Thalmann G, Amos C, Matheson D, Millman R, Alzouebi M, Beesley S, Birtle AJ, Brock S, Cathomas R, Chakraborti P, Chowdhury S, Cook A, Elliott T, Gale J, Gibbs S, Graham JD, Hetherington J, Hughes R, Laing R, McKinna F, McLaren DB, O'Sullivan JM, Parikh O, Peedell C, Protheroe A, Robinson AJ, Srihari N, Srinivasan R, Staffurth J, Sundar S, Tolan S, Tsang D, Wagstaff J, Parmar MK; STAMPEDE investigators. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial. Lancet. 2016 Mar 19;387(10024):1163-77. doi: 10.1016/S0140-6736(15)01037-5. Epub 2015 Dec 21.
PMID: 26719232BACKGROUNDGravis G, Fizazi K, Joly F, Oudard S, Priou F, Esterni B, Latorzeff I, Delva R, Krakowski I, Laguerre B, Rolland F, Theodore C, Deplanque G, Ferrero JM, Pouessel D, Mourey L, Beuzeboc P, Zanetta S, Habibian M, Berdah JF, Dauba J, Baciuchka M, Platini C, Linassier C, Labourey JL, Machiels JP, El Kouri C, Ravaud A, Suc E, Eymard JC, Hasbini A, Bousquet G, Soulie M. Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial. Lancet Oncol. 2013 Feb;14(2):149-58. doi: 10.1016/S1470-2045(12)70560-0. Epub 2013 Jan 8.
PMID: 23306100BACKGROUNDSmith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford ED, Kopyltsov E, Park CH, Alekseev B, Montesa-Pino A, Ye D, Parnis F, Cruz F, Tammela TLJ, Suzuki H, Utriainen T, Fu C, Uemura M, Mendez-Vidal MJ, Maughan BL, Joensuu H, Thiele S, Li R, Kuss I, Tombal B; ARASENS Trial Investigators. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022 Mar 24;386(12):1132-1142. doi: 10.1056/NEJMoa2119115. Epub 2022 Feb 17.
PMID: 35179323BACKGROUNDBoyle HJ, Alibhai S, Decoster L, Efstathiou E, Fizazi K, Mottet N, Oudard S, Payne H, Prentice M, Puts M, Aapro M, Droz JP. Updated recommendations of the International Society of Geriatric Oncology on prostate cancer management in older patients. Eur J Cancer. 2019 Jul;116:116-136. doi: 10.1016/j.ejca.2019.04.031. Epub 2019 Jun 10.
PMID: 31195356BACKGROUNDBellera CA, Rainfray M, Mathoulin-Pelissier S, Mertens C, Delva F, Fonck M, Soubeyran PL. Screening older cancer patients: first evaluation of the G-8 geriatric screening tool. Ann Oncol. 2012 Aug;23(8):2166-2172. doi: 10.1093/annonc/mdr587. Epub 2012 Jan 16.
PMID: 22250183BACKGROUNDQuan H, Li B, Couris CM, Fushimi K, Graham P, Hider P, Januel JM, Sundararajan V. Updating and validating the Charlson comorbidity index and score for risk adjustment in hospital discharge abstracts using data from 6 countries. Am J Epidemiol. 2011 Mar 15;173(6):676-82. doi: 10.1093/aje/kwq433. Epub 2011 Feb 17.
PMID: 21330339BACKGROUNDHorgan AM, Seruga B, Pond GR, Alibhai SM, Amir E, De Wit R, Eisenberger MA, Tannock IF. Tolerability and efficacy of docetaxel in older men with metastatic castrate-resistant prostate cancer (mCRPC) in the TAX 327 trial. J Geriatr Oncol. 2014 Apr;5(2):119-26. doi: 10.1016/j.jgo.2013.12.001. Epub 2014 Jan 2.
PMID: 24495703BACKGROUNDDella Pepa C, Cavaliere C, Rossetti S, Di Napoli M, Cecere SC, Crispo A, De Sangro C, Rossi E, Turitto D, Germano D, Iovane G, Berretta M, D'Aniello C, Pisconti S, Maiorino L, Daniele B, Gridelli C, Pignata S, Facchini G. Predictive Comprehensive Geriatric Assessment in elderly prostate cancer patients: the prospective observational scoop trial results. Anticancer Drugs. 2017 Jan;28(1):104-109. doi: 10.1097/CAD.0000000000000428.
PMID: 27579728BACKGROUNDGerritse FL, Meulenbeld HJ, Roodhart JM, van der Velden AM, Blaisse RJ, Smilde TJ, Erjavec Z, de Wit R, Los M; NePro Study Investigators. Analysis of docetaxel therapy in elderly (>/=70 years) castration resistant prostate cancer patients enrolled in the Netherlands Prostate Study. Eur J Cancer. 2013 Oct;49(15):3176-83. doi: 10.1016/j.ejca.2013.06.008. Epub 2013 Jul 9.
PMID: 23849828BACKGROUNDMaia MC, Pereira AAL, Lage LV, Fraile NM, Vaisberg VV, Kudo G, Barroso-Sousa R, Bastos DA, Dzik C. Efficacy and Safety of Docetaxel in Elderly Patients With Metastatic Castration-Resistant Prostate Cancer. J Glob Oncol. 2018 Sep;4:1-9. doi: 10.1200/JGO.2016.007807. Epub 2017 Mar 27.
PMID: 30241182BACKGROUNDShayegan B, Wallis CJD, Hamilton RJ, Morgan SC, Cagiannos I, Basappa NS, Ferrario C, Gotto GT, Fernandes R, Roy S, Noonan KL, Niazi T, Hotte SJ, Saad F, Hew H, Park-Wyllie L, Chan KFY, Malone S. Real-world utilization and outcomes of docetaxel among older men with metastatic prostate cancer: a retrospective population-based cohort study in Canada. Prostate Cancer Prostatic Dis. 2023 Mar;26(1):74-79. doi: 10.1038/s41391-022-00514-9. Epub 2022 Feb 23.
PMID: 35197558BACKGROUNDItaliano A, Ortholan C, Oudard S, Pouessel D, Gravis G, Beuzeboc P, Bompas E, Flechon A, Joly F, Ferrero JM, Fizazi K. Docetaxel-based chemotherapy in elderly patients (age 75 and older) with castration-resistant prostate cancer. Eur Urol. 2009 Jun;55(6):1368-75. doi: 10.1016/j.eururo.2008.07.078. Epub 2008 Aug 8.
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PMID: 21876321BACKGROUNDWang KY, Ma L, Zhang LL, Hu YC, Jiang JH, Ma Q. Efficacy and safety of docetaxel and prednisolone chemotherapy in very elderly men with metastatic castration-resistant prostate cancer (mCRPC) in real world: a single institute experience. Ann Palliat Med. 2021 Feb;10(2):1438-1444. doi: 10.21037/apm-20-573a. Epub 2020 Oct 15.
PMID: 33081478BACKGROUNDKellokumpu-Lehtinen PL, Harmenberg U, Joensuu T, McDermott R, Hervonen P, Ginman C, Luukkaa M, Nyandoto P, Hemminki A, Nilsson S, McCaffrey J, Asola R, Turpeenniemi-Hujanen T, Laestadius F, Tasmuth T, Sandberg K, Keane M, Lehtinen I, Luukkaala T, Joensuu H; PROSTY study group. 2-Weekly versus 3-weekly docetaxel to treat castration-resistant advanced prostate cancer: a randomised, phase 3 trial. Lancet Oncol. 2013 Feb;14(2):117-24. doi: 10.1016/S1470-2045(12)70537-5. Epub 2013 Jan 4.
PMID: 23294853BACKGROUNDSternberg CN, Castellano D, de Bono J, Fizazi K, Tombal B, Wulfing C, Kramer G, Eymard JC, Bamias A, Carles J, Iacovelli R, Melichar B, Sverrisdottir A, Theodore C, Feyerabend S, Helissey C, Poole EM, Ozatilgan A, Geffriaud-Ricouard C, de Wit R. Efficacy and Safety of Cabazitaxel Versus Abiraterone or Enzalutamide in Older Patients with Metastatic Castration-resistant Prostate Cancer in the CARD Study. Eur Urol. 2021 Oct;80(4):497-506. doi: 10.1016/j.eururo.2021.06.021. Epub 2021 Jul 15.
PMID: 34274136BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lorenzo LL Livi
Azienda Ospedaliero-Universitaria Careggi
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor
Study Record Dates
First Submitted
July 8, 2022
First Posted
July 22, 2022
Study Start
January 1, 2020
Primary Completion
July 1, 2022
Study Completion
July 1, 2022
Last Updated
July 22, 2022
Record last verified: 2022-07