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Trial Title:
BAseLine TEstosterone as a Prognostic and/or Predictive bioMARKer in mHSPC
NCT ID:
NCT05530395
Condition:
Prostate Cancer Metastatic
Conditions: Official terms:
Prostatic Neoplasms
Testosterone
Conditions: Keywords:
Testosterone, biomarker
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Testosterone levels
Description:
Blood sample to determine testosterone levels
Summary:
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
Detailed description:
Biological rationale:
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.
Criteria for eligibility:
Study pop:
Metastatic hormone sensitive prostate cancer (mHSPC) patients diagnosed by any imaging
test (at least CT and/or bone scan).
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Metastatic hormone sensitive prostate cancer (mHSPC) patients diagnosed by any
imaging test (at least CT and bone scan) including:
- 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:
- Any prior androgen deprivation therapy (ADT) scheme 2 years before recruitment. -
Any prior testosterone replacement therapy scheme 2 years before recruitment.
- 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
89 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Universitario Reina Sofía
Address:
City:
Córdoba
Country:
Spain
Facility:
Name:
Hospital Universitario Virgen de las Nieves
Address:
City:
Granada
Country:
Spain
Facility:
Name:
Hospital Universitario Virgen del Rocio
Address:
City:
Seville
Country:
Spain
Start date:
January 1, 2023
Completion date:
January 1, 2026
Lead sponsor:
Agency:
Ignacio Puche Sanz
Agency class:
Other
Collaborator:
Agency:
Hospital Universitario Reina Sofia de Cordoba
Agency class:
Other
Collaborator:
Agency:
Hospitales Universitarios Virgen del Rocío
Agency class:
Other
Collaborator:
Agency:
Hospital Universitario Torrecárdenas
Agency class:
Other
Collaborator:
Agency:
Hospital Neurotraumatologico de Jaen
Agency class:
Other
Collaborator:
Agency:
Hospital San Carlos, Madrid
Agency class:
Other
Collaborator:
Agency:
Institut Mutualiste Montsouris
Agency class:
Other
Collaborator:
Agency:
San Raffaele University Hospital, Italy
Agency class:
Other
Collaborator:
Agency:
Azienda Ospedaliera San Giovanni Battista
Agency class:
Other
Collaborator:
Agency:
Chinese University of Hong Kong
Agency class:
Other
Collaborator:
Agency:
Medical University Innsbruck
Agency class:
Other
Collaborator:
Agency:
University of Padova
Agency class:
Other
Collaborator:
Agency:
UMC Utrecht
Agency class:
Other
Source:
University Hospital Virgen de las Nieves
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05530395
