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Review
. 2024 Nov 13:78:102914.
doi: 10.1016/j.eclinm.2024.102914. eCollection 2024 Dec.

Health-related quality of life outcomes in randomized controlled trials in metastatic hormone-sensitive prostate cancer: a systematic review

Susanne Osanto  1 , Anne-Laurien van de Vliert-Bout  2 , Cristina Alvarez Gomez de Segura  1 , Fabio Efficace  3 , Francesco Sparano  3 , Peter-Paul Willemse  4 , Jan Schoones  5 , Adam Cohen  6 , Sahar Barjesteh van Waalwijk van Doorn-Khosrovani  1   7
Affiliations
Review

Health-related quality of life outcomes in randomized controlled trials in metastatic hormone-sensitive prostate cancer: a systematic review

Susanne Osanto et al. EClinicalMedicine. .

Abstract

Background: Since 2015 multiple combination treatments became available for metastatic hormone-sensitive prostate cancer (mHSPC) without effectiveness cross-comparison. Health-related quality of life (HRQoL) could aid in decision-making.

Methods: We systematically reviewed HRQoL publications (January 2015-September 2024) of phase III randomized controlled trials (RCTs) in mHSPC using PRISMA guidelines, cross-compared HRQoL results and assessed usefulness to support decision-making (PROSPERO: CRD42023470698). International Society for Quality-of-Life Research (ISOQOL) recommended standards were used to assess quality of Patient-reported Outcomes reporting.

Findings: We identified nine HRQoL publications from eight RCTs investigating an estradiol patch, or either radiotherapy, docetaxel, androgen-receptor-pathway-inhibitor (ARPI) abiraterone, apalutamide or enzalutamide added to androgen deprivation therapy (ADT) versus ADT ± placebo in ≥8000 patients. Only three studies were considered to have low overall risk of bias (RoB2). Eight HRQoL measures (1-4 per study) were used; 3/5 RCTs investigating an ARPI measured HRQoL using Brief Pain Inventory (BPI-SF), and Functional Assessment of Cancer Therapy-Prostate (FACT-P). Overall, the quality of PRO reporting was high, but PRO-hypothesis was provided by only 25% and reasons for missing data explained in only 50% of RCTs.

Interpretation: Conceptual and methodological HRQoL heterogeneity, along with risk of biases, hampers cross-comparison and failed to robustly support decision-making underscoring the importance of harmonizing methodological approaches.

Funding: None.

Keywords: Clinical decision-making; Clinical trial; Health-related quality of life (HRQoL); Metastatic hormone-sensitive prostate cancer (mHSPC); Systematic review.

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Conflict of interest statement

FE received funding from Daiichi Sankyo (Institution) and had consultancy or advisory roles for Abbvie, Incyte, Syros, Novartis, and JAZZ Pharmaceuticals; all outside the submitted work. SBvWvD-K has grant funding from EU Cancer Mission (PRIME-ROSE, a European precision cancer medicine trial network and implementation initiative), grant no. 101104269; payment to institution (Leiden University Medical Center). All other authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Prisma flowchart of study selection.
See this image and copyright information in PMC

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