Related Experiment Video
Updated: Sep 6, 2025
A Bioluminescent and Fluorescent Orthotopic Syngeneic Murine Model of Androgen-dependent and Castration-resistant Prostate Cancer
Published on: March 6, 2018
Patient-reported Outcomes in Men with Metastatic Castration-resistant Prostate Cancer Harboring DNA Damage Response
Fred Saad1, Johann de Bono2, Philippe Barthélémy3
1Division of Urology, Centre Hospitalier de l'Université de Montréal (CHUM/CRCHUM), Montreal, QC, Canada.
Background:
Talazoparib has shown antitumor activity with a manageable safety profile in men with metastatic castration-resistant prostate cancer (mCRPC) and DNA damage response (DDR)/homologous recombination repair (HRR) alterations.
Objective:
To evaluate patient-reported health-related quality of life (HRQoL) and pain in patients who received talazoparib in the TALAPRO-1 study, with a special interest in patients harboring breast cancer susceptibility gene 1 or 2 (BRCA1/2) mutations.
Design, Setting, And Participants:
TALAPRO-1 is a single-arm, phase 2 study in men with mCRPC DDR alterations either directly or indirectly involved in HRR, who previously received one to two taxane-based chemotherapy regimens for advanced prostate cancer and whose mCRPC progressed on one or more novel hormonal agents.
Outcome Measurements And Statistical Analysis:
Men completed the European Quality-of-life Five-dimension Five-level scale (EQ-5D-5L), EQ-5D visual analog scale (VAS), and Brief Pain Inventory-Short Form at predefined time points during the study. The patient-reported outcome (PRO) population included men who completed a baseline and one or more postbaseline assessments before study end. Longitudinal mixed-effect models assuming an unstructured covariance matrix were used to estimate the mean (95% confidence interval [CI]) change from baseline for pain and general health status measurements among all patients and patients with BRCA1/2 mutations.
Results And Limitations:
In the 97 men in the PRO population treated with talazoparib (BRCA1/2, n = 56), the mean (95% CI) EQ-5D-5L Index improved (all patients, 0.05 [0.01, 0.08]; BRCA1/2 subset, 0.07 [0.03, 0.10]), as did the EQ-5D VAS scores (all patients, 5.42 [2.65, 8.18]; BRCA1/2 subset, 4.74 [1.07, 8.41]). Improvements in the estimated overall change from baseline (95% CI) in the mean worst pain were observed in all patients (-1.08 [-1.52, -0.65]) and the BRCA1/2 subset (-1.15 [-1.67, -0.62]). The probability of not having had experienced deterioration of worst pain by month 12 was 84% for all patients and 83% for the BRCA1/2 subset.
Conclusions:
In heavily pretreated men with mCRPC and DDR/HRR alterations, talazoparib was associated with improved HRQoL in all patients and the BRCA1/2 subset. In both patient groups, worst pain improved from baseline and the probability of not experiencing a deterioration in worst pain with talazoparib was high.
Patient Summary:
We show that talazoparib was associated at least with no change or improvements in health-related quality of life (HRQoL) and pain burden in men with metastatic castration-resistant prostate cancer and DNA damage response/homologous recombination repair gene alterations in the TALAPRO-1 study. These findings in patient-reported HRQoL and pain complement the antitumor activity and tolerability profile of talazoparib.
Insights
Talazoparib improved health-related quality of life (HRQoL) and reduced pain in men with metastatic castration-resistant prostate cancer (mCRPC) and DNA damage response (DDR)/homologous recombination repair (HRR) alterations. These benefits were observed in all patients and those with BRCA1/2 mutations.
Area of Science:
- Oncology
- Clinical Trials
- Prostate Cancer Research
Background:
- Talazoparib demonstrates antitumor activity and a manageable safety profile in men with metastatic castration-resistant prostate cancer (mCRPC).
- Patients with DNA damage response (DDR) and homologous recombination repair (HRR) alterations are a key focus for talazoparib treatment.
Purpose of the Study:
- To assess patient-reported health-related quality of life (HRQoL) and pain in the TALAPRO-1 study.
- To specifically evaluate HRQoL and pain outcomes in patients with BRCA1/2 mutations treated with talazoparib.
Main Methods:
- The TALAPRO-1 study is a single-arm, phase 2 trial involving heavily pretreated men with mCRPC and DDR/HRR alterations.
- Patient-reported outcomes (PROs) including EQ-5D-5L, EQ-5D VAS, and Brief Pain Inventory-Short Form were collected.
- Longitudinal mixed-effect models were used to analyze changes in HRQoL and pain from baseline.
Main Results:
- Talazoparib treatment led to improvements in EQ-5D-5L Index scores and EQ-5D VAS scores in all patients and the BRCA1/2 subset.
- Significant improvements in worst pain from baseline were observed across all patients and the BRCA1/2 subgroup.
- A high probability (84% overall, 83% in BRCA1/2 subset) of not experiencing pain deterioration by 12 months was noted.
Conclusions:
- Talazoparib is associated with improved HRQoL and pain relief in men with mCRPC and DDR/HRR alterations.
- These patient-reported outcomes complement the known antitumor activity and safety profile of talazoparib.
- The findings support talazoparib's role in managing both cancer progression and symptom burden in this patient population.
