Three- and Seven-month Prostate-specific Antigen Levels as Prognostic Markers for Overall Survival in Metastatic Hormone-sensitive Prostate Cancer: Results from SWOG S1216, a Phase 3 Randomized Trial of Androgen Deprivation Plus Orteronel or Bicalutamide

Mamta Parikh ¹, Catherine Tangen ², Maha H A Hussain ³

¹UC Davis Comprehensive Cancer Center, Sacramento, CA, USA.
²SWOG Statistics and Data Management Center, Seattle, WA, USA.
³Northwestern University, Chicago, IL, USA; Robert H Lurie Comprehensive Cancer Center, US.
⁴Cleveland Clinic, Cleveland, OH, USA.
⁵University of Utah, Salt Lake City, UT, USA.
⁶Kaiser Permanente San Francisco Medical Center, San Francisco, CA, USA.
⁷Johns Hopkins University, Baltimore, MD, USA.
⁸Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
⁹Fox Chase Cancer Center, Philadelphia, PA, USA.
¹⁰University of Washington and Fred Hutchinson Cancer Center, Seattle, WA, USA.
¹¹Moffitt Cancer Center, Tampa, FL, USA.
¹²Washington University School of Medicine in St. Louis, St. Louis, MO, USA.
¹³City of Hope, Goodyear, AZ, USA.
¹⁴USC Norris Comprehensive Cancer Center, Los Angeles, CA, USA.
¹⁵Baylor College of Medicine, Houston, TX, USA.
¹⁶University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.
¹⁷City of Hope Comprehensive Cancer Center, Duarte, CA, USA.

⁰UC Davis Comprehensive Cancer Center, Sacramento, CA, USA.

European Urology Oncology +

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March 24, 2024

View abstract on PubMed

Summary

Prostate-specific antigen (PSA) levels at 3 and 7 months after treatment initiation for metastatic hormone-sensitive prostate cancer (mHSPC) strongly predict overall survival (OS). Early PSA response indicates better outcomes, aiding risk stratification and clinical trial design.

Area Of Science

Oncology
Clinical Trials
Prognostic Biomarkers

Background

Prostate-specific antigen (PSA) decrease is a known prognostic factor in metastatic hormone-sensitive prostate cancer (mHSPC).
mHSPC treatment has evolved with intensified therapies beyond traditional androgen deprivation therapy (ADT).

Purpose Of The Study

To assess the association between PSA levels at 3 and 7 months (PSA-3mo, PSA-7mo) and overall survival (OS).
To evaluate PSA response in mHSPC patients treated with ADT plus bicalutamide or orteronel in the S1216 trial.

Main Methods

Categorized PSA response: Complete Response (CR) ≤0.2 ng/ml, Partial Response >0.2-4 ng/ml, No Response (NR) >4 ng/ml.
Utilized Cox analysis, adjusted for treatment arm and stratification factors, to assess OS association.
Evaluated both PSA-7mo (prespecified) and PSA-3mo associations with OS.

Main Results

A total of 1251 (PSA-3mo) and 1231 (PSA-7mo) patients were evaluable.
PSA-7mo CR was linked to improved OS versus NR (HR: 0.20; p<0.0001).
PSA-3mo CR also showed a significant association with improved OS versus NR (HR: 0.34; p<0.0001).
Treatment arm did not influence the PSA response-survival association.

Conclusions

PSA-3mo and PSA-7mo responses are strongly associated with overall survival in mHSPC.
These PSA markers can aid in early identification of high-risk patients.
PSA response data can inform patient counseling and future clinical trial designs targeting specific patient subgroups.

Keywords:

Biomarker Castration sensitive Hormone sensitive Prostate cancer Prostate-specific antigen

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