Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer

Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.

Abstract

Background: Biomarkers for metastatic castration-resistant prostatic cancer (mCRPC) are an unmet medical need.

Methods: The prognostic and predictive value for survival and response to salvage hormonal therapy (SHT) of baseline testosterone level (TL) was analysed in a cohort of 101 mCRPC patients participating in 9 non-hormonal first-line chemotherapy phase II-III trials. Inclusion criteria in all trials required a TL of <50 ng dl(-1).

Results: Median age: 70 years; visceral metastases: 19.8%; median prostate-specific antigen (PSA): 50.7 ng ml(-1); median TL: 11.5 ng dl(-1). Median overall survival (OS; 24.5 months) was significantly longer if baseline TL was above (High TL; n=52) than under (Low TL; n=49) the TL median value (32.7 vs 22.4 months, respectively; P=0.0162, hazard ratio (HR)=0.6). The presence of anaemia was an unfavourable prognostic factor (median OS: 20.6 vs 28.4 months; P=0.0025, HR=1.88 (CI95%: 1.01-3.48)). Patients presenting both anaemia and low testosterone had a worse outcome compared to those with one or none of them (median OS: 17.9 vs 22.4 vs 38.1 months; P=0.0024). High vs Low TL was associated with PSA response rate (55.6% vs 21.7%) in 41 patients receiving SHT.

Conclusion: Testosterone level under castration range was a prognostic factor for survival mCRPC patients. The PSA response to SHT differed depending on TLs. Testosterone levels might help in treatment decision.

Trial registration: ClinicalTrials.gov NCT00278993 NCT00321620 NCT00411528 NCT00519285 NCT00642018 NCT00744497 NCT01057810 NCT01188187 NCT01308567.

Publication types

  • Clinical Trial, Phase II
  • Clinical Trial, Phase III

MeSH terms

  • Aged
  • Aged, 80 and over
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Metastasis
  • Predictive Value of Tests
  • Prognosis
  • Prostatic Neoplasms, Castration-Resistant / blood*
  • Prostatic Neoplasms, Castration-Resistant / drug therapy
  • Prostatic Neoplasms, Castration-Resistant / mortality*
  • Testosterone / blood*

Substances

  • Testosterone

Associated data

  • ClinicalTrials.gov/NCT00278993
  • ClinicalTrials.gov/NCT00321620
  • ClinicalTrials.gov/NCT00411528
  • ClinicalTrials.gov/NCT00519285
  • ClinicalTrials.gov/NCT00642018
  • ClinicalTrials.gov/NCT00744497
  • ClinicalTrials.gov/NCT01057810
  • ClinicalTrials.gov/NCT01188187
  • ClinicalTrials.gov/NCT01308567