BAseLine TEstosterone as a Prognostic and/or Predictive bioMARKer in mHSPC
NCT ID: NCT05530395
Last Updated: 2022-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
300 participants
OBSERVATIONAL
2023-01-01
2026-01-01
Brief Summary
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Detailed Description
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The 'androgen hypothesis' asserts that prostate cancer (PCa) development and progression is driven by androgens. There is significant evidence that androgens promote prostate cancer in experimental models. However, there is no clear evidence that elevations in endogenous testosterone levels promote the development of prostate cancer in humans. Indeed, 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 PCa pathogenesis de novo. In reviewing the literature involving PCa development in PCa naive patients, there are studies implicating elevated testosterone, studies implicating lower testosterone, and studies with no association of testosterone and PCa risk.
A recent review in 2015 delved into the controversial role of androgens and prostate cancer and explains the different theories about the ambiguous action of testosterone on the prostate. In 2012, a research proposed the nonlinear U-shaped behaviour or time dependency theory, which postulates that the endocrine biology of the prostate tissue depends on exposure time at a given androgen concentration, which "relies on the fluctuation of the levels of circulating sex steroids during the lifespan of the individual". Another model is the saturation model based on the observations that prostate tissue is extremely sensitive to changes in serum testosterone at low concentrations. This model suggests that there is a nonprotective effect of low testosterone against PCa but tissue becomes indifferent to changes when increasing androgen concentration reach a limit (saturation point), beyond which no further androgen-driven changes are observed. Anyway, the lack of a satisfying model to explain the relationship between androgens and PCa is simply the consequence of insufficient knowledge of the real intrinsic physiopathology of this disease.
Clinical rationale:
Approximately 15% of mHSPC patients primarily fail to respond to ADT. A recent consensus statement on circulating biomarkers for advanced prostate cancer highlighted the urgent need for prospective trials to clinically qualify circulating biomarkers, the greatest need being metastatic PCa. On the other hand, a very recent paper analysed baseline testosterone in hormone-naïve advanced PCa patients undergoing continuous medical castration and selected from 2 large Phase III RCTs. It demonstrated that lower baseline serum testosterone was significantly associated with worse survival end-points and warrants further prospective research in this scenario.
In this era of complex and expensive next-generation markers, this simple, cheap, and well-known biomarker may still have something to say in PCa.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Testosterone levels
Blood sample to determine testosterone levels
Eligibility Criteria
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Inclusion Criteria
* Any newly diagnosed mHSPC with no prior treatments.
* Primarily treated PCa that have progressed to mHSPC with no prior ADT in the last 2 years.
* Patients receiving ADT + EBRT as primary treatment will also be included.
* Patients who agree to be followed prospectively according to routine clinical practice in the context of this study.
Exclusion Criteria
* Previous intermittent ADT schemes.
* Prior testicular excision surgery.
* Absence or testicular atrophy from any cause.
* Whenever further prospective clinical follow-up is not possible or patient do not accept follow-up in the context of this study.
18 Years
89 Years
MALE
No
Sponsors
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Hospital Universitario Reina Sofia de Cordoba
OTHER_GOV
Hospitales Universitarios Virgen del Rocío
OTHER
Hospital Universitario Torrecárdenas
OTHER
Hospital Neurotraumatologico de Jaen
OTHER
Hospital San Carlos, Madrid
OTHER
Institut Mutualiste Montsouris
OTHER
San Raffaele University Hospital, Italy
OTHER
Azienda Ospedaliera San Giovanni Battista
OTHER
Chinese University of Hong Kong
OTHER
Medical University Innsbruck
OTHER
University of Padova
OTHER
UMC Utrecht
OTHER
Ignacio Puche Sanz
OTHER
Responsible Party
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Ignacio Puche Sanz
Principal Investigator
Principal Investigators
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Ignacio Puche
Role: PRINCIPAL_INVESTIGATOR
Fundación para la Investigación Biosanitaria de Andalucía Oriental (FIBAO)
Locations
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Hospital Universitario Reina Sofía
Córdoba, Andalusia, Spain
Hospital Universitario Virgen de las Nieves
Granada, Andalusia, Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Countries
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Central Contacts
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References
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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.
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.
Other Identifiers
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BATEMARK-YAUPCa-21
Identifier Type: -
Identifier Source: org_study_id
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