NCT05530395|Unknown
BAseLine TEstosterone as a Prognostic and/or Predictive bioMARKer in mHSPC
Baseline Testosterone as a Prognostic and/or Predictive Biomarker in Metastatic Hormone Sensitive Prostate Cancer
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Baseline Testosterone as a Prognostic and/or Predictive Biomarker in Metastatic Hormone Sensitive Prostate Cancer
Sponsor study identifier
observational
300
1 country
3
Study Start
January 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Despite large amounts of basic-science data supporting a role for androgens in PCa pathogenesis, there are conflicting clinical data on the role of endogenous testosterone in human de novo PCa pathogenesis. The investigators hypothesize that lower baseline serum testosterone is significantly associated with worse clinical outcomes in mHSPC patients undergoing continuous medical castration
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2, 2022
Actual (reported)September 7, 2022
Actual (reported)January 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Early treatment failure
Proportion of patients with PSA progression or death from PCa within 12 months after initiation of treatment.
1 year
PSA response
Lowest PSA (nadir) reached after initiation of treatment
6 months
Testosterone response.
6 months
Biochemical progression-free survival (bPFS)
1 year
Radiologic progression-free survival (rPFS)
1 year
Time to CRPC
1 year
Blood sample to determine testosterone levels
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Metastatic hormone sensitive prostate cancer (mHSPC) patients diagnosed by any imaging test (at least CT and/or bone scan).
Hospital Universitario Reina Sofía
Córdoba, Andalusia, Spain
Hospital Universitario Virgen de las Nieves
Granada, Andalusia, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Michaud JE, Billups KL, Partin AW. Testosterone and prostate cancer: an evidence-based review of pathogenesis and oncologic risk. Ther Adv Urol. 2015 Dec;7(6):378-87. doi: 10.1177/1756287215597633.
Pierorazio PM, Ferrucci L, Kettermann A, Longo DL, Metter EJ, Carter HB. Serum testosterone is associated with aggressive prostate cancer in older men: results from the Baltimore Longitudinal Study of Aging. BJU Int. 2010 Mar;105(6):824-9. doi: 10.1111/j.1464-410X.2009.08853.x. Epub 2009 Sep 14.
Blood
Ignacio Puche
Fundación para la Investigación Biosanitaria de Andalucía Oriental (FIBAO)
First Submitted
September 2, 2022
First Posted
September 7, 2022
Study Start
January 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 1, 2025
Whole-Body Diffusion-Weighted Magnetic Resonance Imaging (MRI) as a Response Biomarker for Metastatic Prostate Cancer
Contact the study team to confirm eligibility.
Yano M, Imamoto T, Suzuki H, Fukasawa S, Kojima S, Komiya A, Naya Y, Ichikawa T. The clinical potential of pretreatment serum testosterone level to improve the efficiency of prostate cancer screening. Eur Urol. 2007 Feb;51(2):375-80. doi: 10.1016/j.eururo.2006.08.047. Epub 2006 Sep 12.
Rajek NJ. Developing an evening clinical experience for baccalaureate community health nursing students. J Nurs Educ. 1987 May;26(5):197-200. doi: 10.3928/0148-4834-19870501-07.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 14, 2022
Record last verified: 2022-09
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Source: ClinicalTrials.gov.
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