Clinical trial · Observational
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
NCT05530395CI-TRIAL-00060844unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Testosterone levels | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Early treatment failure
- timeFrame
- 1 year
- description
- Proportion of patients with PSA progression or death from PCa within 12 months after initiation of treatment.
- measure
- PSA response
- timeFrame
- 6 months
- description
- Lowest PSA (nadir) reached after initiation of treatment
Secondary outcomes (4)
- measure
- Testosterone response.
- timeFrame
- 6 months
- description
- %percent of decrease in testosterone levels at the moment of PSA nadir.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDMichaud 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. PMID 26622322
- BACKGROUNDPierorazio 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. PMID 19751256
- BACKGROUNDYano 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. PMID 17005316
- BACKGROUNDRajek 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. PMID 3035140