Trial Outcomes & Findings for Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (China Cohort) (NCT NCT05171816)

Approximately 108 patients were planned to be randomized in the study. Actually 162 patients were screened, and 110 patients were randomized successfully.

Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (China Cohort)

Radiological progression free survival is defined as the time from randomisation until the earlier date of radiological progression or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomised therapy or receives another anticancer therapy prior to progression. Per RECIST v1.1, progression is defined as the sum of TLs has a 20% and absolute ≥ 5mm increase from nadir, and/or unequivocal progression in any non target lesions, and/or any new lesion identified. Per PCWG3, progression on a bone scan is defined as 2 or more new lesions observed from the first visit after baseline compared to baseline, or from all other visits compared to first visit after baseline. A confirmatory scan is required.

Overall survival is defined as the time from date of randomisation to death due to any cause regardless of whether the patient withdraws from randomised therapy or receives another anticancer therapy. The 22Jan2024 DCO is the final data cut-off for the OS analysis and therefore no further updates will be made.

Time to first subsequent anticancer therapy (excluding radiotherapy) is defined as the time from randomisation to the earlier of start date of the first subsequent anti cancer therapy after discontinuation of randomised treatment or death from any cause.

Time to pain progression is defined as time from randomisation to pain progression based on the Brief Pain Inventory-Short Form (BPI-SF) Item 3 "worst pain in 24 hours" (range 0-10, a higher score indicates worse pain) and opiate analgesic use (Analgesic quantification algorithm \[AQA\] score, range 0-7, a higher score indicates increased opioid use). For patients who are asymptomatic at baseline: A ≥2 point change from baseline in average (4-7 days) worst pain score observed at 2 consecutive visits or initiation of opioid use; For patients who are symptomatic at baseline: A ≥2 point change from baseline in average (4-7 days) worst pain score observed at 2 consecutive visits and an average worst pain score ≥4, and no decrease in average opioid use (≥1-point decrease in AQA score from a starting value of ≥2), or increase in opioid use (≥1-point increase, or ≥2-point increase if the starting value is 0) at 2 consecutive follow-up visits.

Time to opiate use is defined as the time from date of randomisation to the date of first opiate use for cancer related pain.

Time from date of randomisation to date of first symptomatic skeletal-related event as defined by any of the following or a combination: * Use of radiation therapy to prevent or relieve skeletal symptoms. * Occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral). * Occurrence of spinal cord compression. * Orthopaedic surgical intervention for bone metastasis.

The time to PFS2 is defined as the time from date of randomisation to date of second progression on next-line (immediately after study treatment) anticancer therapy or death, whichever occurs earlier.

All BPI-SF pain items including "worst pain" are scored on a 0-10 numeric rating scale (NRS) with 0=No Pain and 10=Worst Pain Imaginable. The pain severity domain consists of 4 items (item #3, item #4, item #5, and item #6) which assess pain at its "worst," "least," "average," and "now" (current pain) respectively on the 11-point NRS. The overall pain severity score is calculated for each patient/visit as the mean of the individual non-missing items. The pain interference domain score is a mean of 7 items: general activity (item #9A), mood (item #9B), walking ability (item #9C), normal work (item #9D), relations with other people (item #9E), sleep (item #9F), and enjoyment of life (item #9G), each scored on an 11-point NRS from 0 (Does not interfere) to 10 (Completely interferes). BPI-SF worst pain, pain severity and pain interference score changes can be a minimum of -10 and a maximum of 10. A negative change from baseline value indicates improvement.

The following measures are calculated from the FACT-P questionnaire, the resulting value is the total score for the associated questions or scaled scores: * Physical well-being subscale (PWB) (Questions GP1 to GP7) * Social/family well-being subscale (SWB) (Questions GS1 to GS7) * Emotional well-being subscale (EWB) (Questions GE1 to GE6) * Functional well-being subscale (FWB) (Questions GF1 to GF7) * Prostate cancer subscale (PCS) (Questions C2, C6, P1 to P8, BL2 and BL5) The scores range from 0 ("Not at all") to 4 ("Very much") for positively phrased questions, and from 0 ("Very much") to 4 ("Not at all") for negatively phrased questions. Total FACT-P score is the sum of PWB, SWB, EWB, FWB and PCS. FACT-P total score changes can be a minimum of -156 and a maximum of 156. A positive value indicates improvement. FACT-G total score is the sum of PWB, SWB, EWB and FWB. FACT-G Total score changes can be a minimum of -108 and a maximum of 108. A positive value indicates improvement.