A Phase 3 interventional study of olaparib and abiraterone acetate in Metastatic Castration-resistant Prostate Cancer, sponsored by AstraZeneca. Active, not recruiting at 26 sites in China. Open to male participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety (including evaluating side effects) of combination of olaparib and abiraterone versus placebo and abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have received no prior cytotoxic chemotherapy or new hormonal agents (NHAs) at metastatic castration-resistant prostate cancer (mCRPC) stage.
PROpel is a phase III study evaluating the efficacy, safety, and tolerability of olaparib versus placebo when given in addition to abiraterone to patients with metastatic castration-resistant prostate cancer (mCRPC) who have not received prior chemotherapy or new hormonal agents (NHAs) for metastatic castration-resistant prostate cancer (mCRPC) (first-line setting).
Approximately 720 patients globally were planned to be randomized in PROpel in a 1:1 ratio to treatment with either olaparib and abiraterone or placebo and abiraterone. Enrolment had completed with a total of 796 patients randomised. Following the completion of global enrolment, the China cohort will randomise approximately 108 additional patients at sites in China, also in a 1:1 ratio.
This cohort will enable standalone safety and efficacy analyses to support Chinese regulatory requirements. Patients from China will not be included in the Full Analysis Set for the global study analysis. In addition, all of the statistical analyses defined in this SAP will be performed using all patients randomised at sites in Asian countries (South Korea and Japan) excluding China, to be designated the Asian subgroup analysis.
Patients will receive oral treatment with olaparib 300 mg twice daily + abiraterone 1000 mg once daily or placebo twice daily + abiraterone 1000 mg once daily. Patients in both treatment groups will also receive either prednisone or prednisolone 5 mg twice daily.
AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 358 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
For inclusion in i) the optional exploratory genetic research and ii) the optional biomarker research, patients must fulfill the following criteria:
If a patient declines to participate in the optional exploratory genetic research or the optional biomarker research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study.
Exclusion Criteria:
Olaparib is available as a film-coated tablet containing 100 milligrams (mg) or 150 milligrams (mg) of olaparib. Subjects will be administered olaparib orally at a dose of 300 milligrams (mg) twice daily (bid). The initial dosage of 300 milligrams (mg) twice daily will be composed of 2 x 150 milligrams (mg) tablets per dose. The 100 milligrams (mg) and 150 milligrams (mg) tablets will be used to manage dose reductions during the study. Abiraterone acetate with prednisone or prednisolone will be sourced locally as commercially available materials. Subjects will be administered abiraterone orally at a dose of 1000 milligrams (mg) once daily, in combination with prednisone or prednisolone 5 milligrams (mg) administered orally twice daily.
Drug: olaparib · Drug: abiraterone acetate
Placebo to match olaparib is available as a film-coated tablet in 100 milligrams (mg) or 150 milligrams (mg). Subjects will be administered placebo orally at a dose of 300 milligrams (mg) twice daily (bid). The initial dosage of 300 milligrams (mg) twice daily will be composed of 2 x 150 milligrams (mg) tablets per dose. The 100 milligrams (mg) and 150 milligrams (mg) tablets will be used to manage dose reductions during the study. Abiraterone acetate with prednisone or prednisolone will be sourced locally as commercially available materials. Subjects will be administered abiraterone orally at a dose of 1000 milligrams (mg) once daily, in combination with prednisone or prednisolone 5 milligrams (mg) administered orally twice daily.
Drug: abiraterone acetate
300 mg (2 x 150 milligrams (mg) tablets) twice daily
Also known as: Lynparza
1000 milligrams (mg) once daily
Also known as: Zytiga
Radiological Progression Free Survival (rPFS)
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.
Time frame: Tumour imaging CT/MRI and bone scan were assessed every 8 weeks from randomisation to week 24 and then every 12 weeks until RECIST progression. Patients were followed up for 479 days (approx 16 months) at minimum and 913 days (approx 30 months) at maximum
Overall Survival (OS)
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 frame: Assessed every 12 weeks from randomisation until death or data cut-off. The endpoint was followed up for 479 days (approx 16 months) at minimum and 913 days (approx 30 months) at maximum.
Time to First Subsequent Anticancer Therapy or Death (TFST)
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 frame: Assessed from from randomization on 30 day follow-up after last dose of study medication and every 12 weeks after that until DCO. The endpoint was followed up for 479 days (approx 16 months) at minimum and 913 days (approx 30 months) at maximum.
Time to Pain Progression (TTPP)
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 frame: The BPI-SF and AQA were assessed on screening, day 1, day 15, day 29, day 43, day 57, day 71, and every 4 weeks after week 13 until DCO. The endpoint was followed up for 479 days (approx 16 months) at minimum and 913 days (approx 30 months) at maximum.
Time to Opiate Use
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 frame: Assessed on screening, days 1, 29, and 57, every 4 weeks after week 13, treatment discontinuation, and 30-day follow-up after last dose of study medication. Followed up for 479 days (approx 16 months) at minimum and 913 days (approx 30 months) at maximum.
Time to a Symptomatic Skeletal-Related Event (SSRE)
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.
Time frame: Assessed at every visit from randomisation up to and including treatment discontinuation visit. The endpoint was followed up for 479 days (approx 16 months) at minimum and 913 days (approx 30 months) at maximum.
Time to Second Progression or Death (PFS2)
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.
Time frame: Assessed from randomization every 12 weeks following the progression event used for PFS and the start of the next-line anticancer therapy. The endpoint was followed up for 479 days (approx 16 months) at minimum and 913 days (approx 30 months) at maximum.
Change From Baseline in BPI-SF Pain Severity and Pain Interference
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.
Time frame: Assessed from date of first subject randomised: 23Jul2021 to data cut off (China DCO): 22Jan2024 (913 days). BPI-SF were completed by patients daily for 7 consecutive days every 4 weeks. Change from baseline is reported every 4 weeks until week 49.
Change From Baseline in Functional Assessment of Cancer Therapy- Prostate Cancer (FACT-P)
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.
Time frame: Assessed from date of first subject randomised: 23Jul2021 to data cut off (China DCO): 22Jan2024 (913 days). FACT-P were assessed every 4 weeks from Day 1 until Week 52. Change from baseline is reported every 4 weeks until week 49.
Approximately 108 patients were planned to be randomized in the study. Actually 162 patients were screened, and 110 patients were randomized successfully.
| Milestone | Olaparib 300 mg bd + Abiraterone 1000 mg qd | Placebo bd + Abiraterone 1000 mg qd |
|---|---|---|
| Started | 54 | 56 |
| Completed | 36 | 40 |
| Not completed | 18 | 16 |
| Withdrew: Death | 18 | 16 |
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.
| Months | Olaparib 300 mg bd + Abiraterone 1000 mg qd | Placebo bd + Abiraterone 1000 mg qd |
|---|---|---|
| Radiological Progression Free Survival (rPFS) | 14.75 (12.06 to 22.11) | NA (NA to NA) |
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.
| Months | Olaparib 300 mg bd + Abiraterone 1000 mg qd | Placebo bd + Abiraterone 1000 mg qd |
|---|---|---|
| Overall Survival (OS) | 27.83 (27.83 to NA) | NA (NA to NA) |
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.
| Months | Olaparib 300 mg bd + Abiraterone 1000 mg qd | Placebo bd + Abiraterone 1000 mg qd |
|---|---|---|
| Time to First Subsequent Anticancer Therapy or Death (TFST) | 19.1 (15.4 to NA) | 17.6 (10.6 to NA) |
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.
| Months | Olaparib 300 mg bd + Abiraterone 1000 mg qd | Placebo bd + Abiraterone 1000 mg qd |
|---|---|---|
| Time to Pain Progression (TTPP) | NA (NA to NA) | NA (NA to NA) |
Time to opiate use is defined as the time from date of randomisation to the date of first opiate use for cancer related pain.
| Months | Olaparib 300 mg bd + Abiraterone 1000 mg qd | Placebo bd + Abiraterone 1000 mg qd |
|---|---|---|
| Time to Opiate Use | NA (NA to NA) | NA (NA to NA) |
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.
| Months | Olaparib 300 mg bd + Abiraterone 1000 mg qd | Placebo bd + Abiraterone 1000 mg qd |
|---|---|---|
| Time to a Symptomatic Skeletal-Related Event (SSRE) | NA (NA to NA) | NA (NA to NA) |
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.
| Months | Olaparib 300 mg bd + Abiraterone 1000 mg qd | Placebo bd + Abiraterone 1000 mg qd |
|---|---|---|
| Time to Second Progression or Death (PFS2) | 28.71 (NA to NA) | NA (NA to NA) |
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.
| Score | Olaparib 300 mg bd + Abiraterone 1000 mg qd | Placebo bd + Abiraterone 1000 mg qd |
|---|---|---|
| Change from baseline in BPI-SF worst pain - Week 5 | -0.70 (-1.25 to -0.15) | -0.66 (-1.13 to -0.19) |
| Change from baseline in BPI-SF worst pain - Week 9 | -1.37 (-2.05 to -0.69) | -0.61 (-1.11 to -0.12) |
| Change from baseline in BPI-SF worst pain - Week 13 | -1.42 (-2.16 to -0.69) | -0.35 (-0.69 to -0.01) |
| Change from baseline in BPI-SF worst pain - Week 17 | -1.22 (-2.01 to -0.43) | -0.38 (-0.94 to 0.18) |
| Change from baseline in BPI-SF worst pain - Week 21 | -1.06 (-1.71 to -0.40) | -0.63 (-1.20 to -0.06) |
| Change from baseline in BPI-SF worst pain - Week 25 | -0.95 (-1.63 to -0.27) | -0.74 (-1.33 to -0.16) |
| Change from baseline in BPI-SF worst pain - Week 29 | -1.24 (-1.88 to -0.60) | -0.26 (-0.84 to 0.33) |
| Change from baseline in BPI-SF worst pain - Week 33 | -0.78 (-1.66 to 0.09) | -0.66 (-1.31 to -0.01) |
| Change from baseline in BPI-SF worst pain - Week 37 | -0.61 (-1.25 to 0.03) | -0.59 (-1.19 to 0.02) |
| Change from baseline in BPI-SF worst pain - Week 41 | -0.10 (-1.09 to 0.88) | -0.43 (-0.97 to 0.10) |
| Change from baseline in BPI-SF worst pain - Week 45 | -0.46 (-1.47 to 0.56) | -0.19 (-0.74 to 0.36) |
| Change from baseline in BPI-SF worst pain - Week 49 | 0.11 (-0.81 to 1.02) | -0.06 (-0.59 to 0.47) |
| Change from baseline in BPI-SF overall pain severity score - Week 5 | -0.51 (-0.98 to -0.05) | -0.56 (-0.98 to -0.13) |
| Change from baseline in BPI-SF overall pain severity score - Week 9 | -1.12 (-1.65 to -0.60) | -0.54 (-1.00 to -0.08) |
| Change from baseline in BPI-SF overall pain severity score - Week 13 | -1.21 (-1.78 to -0.63) | -0.31 (-0.60 to -0.02) |
| Change from baseline in BPI-SF overall pain severity score - Week 17 | -1.02 (-1.67 to -0.38) | -0.34 (-0.85 to 0.16) |
| Change from baseline in BPI-SF overall pain severity score - Week 21 | -0.87 (-1.39 to -0.35) | -0.57 (-1.09 to -0.06) |
| Change from baseline in BPI-SF overall pain severity score - Week 25 | -0.81 (-1.37 to -0.25) | -0.68 (-1.22 to -0.14) |
| Change from baseline in BPI-SF overall pain severity score - Week 29 | -0.94 (-1.46 to -0.42) | -0.26 (-0.71 to 0.18) |
| Change from baseline in BPI-SF overall pain severity score - Week 33 | -0.72 (-1.36 to -0.08) | -0.63 (-1.20 to -0.06) |
| Change from baseline in BPI-SF overall pain severity score - Week 37 | -0.43 (-0.90 to 0.03) | -0.51 (-0.94 to -0.08) |
| Change from baseline in BPI-SF overall pain severity score - Week 41 | -0.19 (-0.74 to 0.36) | -0.42 (-0.83 to -0.01) |
| Change from baseline in BPI-SF overall pain severity score - Week 45 | -0.45 (-1.12 to 0.22) | -0.26 (-0.65 to 0.12) |
| Change from baseline in BPI-SF overall pain severity score - Week 49 | -0.01 (-0.52 to 0.50) | -0.21 (-0.64 to 0.21) |
| Change from baseline in BPI-SF overall pain interference score - Week 5 | -0.21 (-0.75 to 0.33) | -0.30 (-0.71 to 0.12) |
| Change from baseline in BPI-SF overall pain interference score - Week 9 | -0.88 (-1.41 to -0.35) | -0.33 (-0.83 to 0.17) |
| Change from baseline in BPI-SF overall pain interference score - Week 13 | -0.98 (-1.53 to -0.42) | -0.14 (-0.44 to 0.15) |
| Change from baseline in BPI-SF overall pain interference score - Week 17 | -0.83 (-1.47 to -0.19) | -0.16 (-0.68 to 0.37) |
| Change from baseline in BPI-SF overall pain interference score - Week 21 | -0.70 (-1.24 to -0.15) | -0.31 (-0.84 to 0.21) |
| Change from baseline in BPI-SF overall pain interference score - Week 25 | -0.53 (-1.14 to 0.09) | -0.42 (-0.97 to 0.13) |
| Change from baseline in BPI-SF overall pain interference score - Week 29 | -0.78 (-1.33 to -0.23) | 0.02 (-0.37 to 0.42) |
| Change from baseline in BPI-SF overall pain interference score - Week 33 | -0.70 (-1.43 to 0.03) | -0.35 (-0.94 to 0.24) |
| Change from baseline in BPI-SF overall pain interference score - Week 37 | -0.21 (-0.68 to 0.26) | -0.09 (-0.50 to 0.31) |
| Change from baseline in BPI-SF overall pain interference score - Week 41 | -0.05 (-0.59 to 0.49) | -0.18 (-0.57 to 0.21) |
| Change from baseline in BPI-SF overall pain interference score - Week 45 | -0.36 (-1.01 to 0.30) | -0.13 (-0.52 to 0.26) |
| Change from baseline in BPI-SF overall pain interference score - Week 49 | 0.09 (-0.39 to 0.57) | -0.15 (-0.56 to 0.26) |
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.
| Score | Olaparib 300 mg bd + Abiraterone 1000 mg qd | Placebo bd + Abiraterone 1000 mg qd |
|---|---|---|
| Change from baseline in FACT-P Total - Week 5 | -4.43 (-11.40 to 2.54) | -0.84 (-4.92 to 3.25) |
| Change from baseline in FACT-P Total - Week 9 | -4.95 (-12.69 to 2.79) | 1.00 (-4.80 to 6.79) |
| Change from baseline in FACT-P Total - Week 13 | -1.51 (-7.95 to 4.92) | -3.07 (-8.49 to 2.36) |
| Change from baseline in FACT-P Total - Week 17 | -1.82 (-10.00 to 6.36) | -3.51 (-9.63 to 2.60) |
| Change from baseline in FACT-P Total - Week 21 | -6.60 (-15.08 to 1.88) | -0.54 (-7.07 to 6.00) |
| Change from baseline in FACT-P Total - Week 25 | -6.55 (-16.46 to 3.36) | -1.68 (-8.30 to 4.95) |
| Change from baseline in FACT-P Total - Week 29 | -1.32 (-11.86 to 9.22) | 0.62 (-6.28 to 7.53) |
| Change from baseline in FACT-P Total - Week 33 | -7.23 (-17.13 to 2.68) | -0.75 (-6.97 to 5.46) |
| Change from baseline in FACT-P Total - Week 37 | -3.21 (-11.48 to 5.07) | -4.87 (-11.95 to 2.22) |
| Change from baseline in FACT-P Total - Week 41 | -7.16 (-15.95 to 1.63) | 0.47 (-6.04 to 6.99) |
| Change from baseline in FACT-P Total - Week 45 | -8.28 (-17.49 to 0.92) | -1.69 (-7.76 to 4.39) |
| Change from baseline in FACT-P Total - Week 49 | -9.78 (-17.36 to -2.21) | -1.35 (-6.72 to 4.02) |
| Change from baseline in FACT-G Total - Week 5 | -4.85 (-9.84 to 0.14) | -1.75 (-4.92 to 1.42) |
| Change from baseline in FACT-G Total - Week 9 | -4.55 (-10.27 to 1.17) | -0.07 (-3.80 to 3.66) |
| Change from baseline in FACT-G Total - Week 13 | -2.43 (-6.97 to 2.11) | -3.79 (-7.41 to -0.16) |
| Change from baseline in FACT-G Total - Week 17 | -2.45 (-8.19 to 3.29) | -4.30 (-7.98 to -0.62) |
| Change from baseline in FACT-G Total - Week 21 | -5.26 (-11.49 to 0.98) | -2.10 (-6.40 to 2.20) |
| Change from baseline in FACT-G Total - Week 25 | -6.23 (-13.50 to 1.04) | -3.45 (-8.39 to 1.49) |
| Change from baseline in FACT-G Total - Week 29 | -2.26 (-10.15 to 5.63) | -1.35 (-6.27 to 3.57) |
| Change from baseline in FACT-G Total - Week 33 | -6.15 (-13.40 to 1.09) | -2.75 (-7.38 to 1.87) |
| Change from baseline in FACT-G Total - Week 37 | -1.32 (-7.26 to 4.62) | -5.14 (-10.32 to 0.04) |
| Change from baseline in FACT-G Total - Week 41 | -5.72 (-12.30 to 0.86) | -1.08 (-5.90 to 3.75) |
| Change from baseline in FACT-G Total - Week 45 | -5.70 (-12.48 to 1.08) | -2.27 (-6.78 to 2.24) |
| Change from baseline in FACT-G Total - Week 49 | -7.78 (-13.34 to -2.22) | -1.51 (-5.13 to 2.11) |
Collected over Adverse events with an onset date, or worsen, on or after the date of first dose and up to and including 30 days following discontinuation of randomised treatment. Assessed from date of randomisation to data cut off (China DCO): 22Jan2024 (Approx. 2 years 7 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Olaparib 300 mg bd + Abiraterone 1000 mg qd | 18/54 (33.3%) | 23/54 (42.6%) | 53/54 (98.1%) |
| Placebo bd + Abiraterone 1000 mg qd | 16/56 (28.6%) | 21/56 (37.5%) | 54/56 (96.4%) |
| Event | Olaparib 300 mg bd + Abiraterone 1000 mg qd | Placebo bd + Abiraterone 1000 mg qd |
|---|---|---|
| PneumoniaInfections and infestations | 4/54 | 0/56 |
| CataractEye disorders | 2/54 | 0/56 |
| DeathGeneral disorders | 2/54 | 1/56 |
| Covid-19Infections and infestations | 2/54 | 2/56 |
| Urinary tract infectionInfections and infestations | 2/54 | 0/56 |
| Type 2 diabetes mellitusMetabolism and nutrition disorders | 0/54 | 2/56 |
| Abdominal painGastrointestinal disorders | 1/54 | 0/56 |
| DuodenitisGastrointestinal disorders | 1/54 | 0/56 |
| Gastric ulcerGastrointestinal disorders | 1/54 | 0/56 |
| Gastritis erosiveGastrointestinal disorders | 1/54 | 0/56 |
| Event | Olaparib 300 mg bd + Abiraterone 1000 mg qd | Placebo bd + Abiraterone 1000 mg qd |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 42/54 | 18/56 |
| Blood bilirubin increasedInvestigations | 14/54 | 15/56 |
| Alanine aminotransferase increasedInvestigations | 11/54 | 14/56 |
| Lymphocyte count decreasedInvestigations | 13/54 | 5/56 |
| HyperlipidaemiaMetabolism and nutrition disorders | 9/54 | 13/56 |
| HypokalaemiaMetabolism and nutrition disorders | 7/54 | 13/56 |
| HypercholesterolaemiaMetabolism and nutrition disorders | 10/54 | 12/56 |
| Aspartate aminotransferase increasedInvestigations | 11/54 | 11/56 |
| White blood cell count decreasedInvestigations | 11/54 | 3/56 |
| HypertriglyceridaemiaMetabolism and nutrition disorders | 11/54 | 11/56 |
Full analysis set
| Age, Continuous(Years) | Olaparib 300 mg bd + Abiraterone 1000 mg qd | Placebo bd + Abiraterone 1000 mg qd | Total |
|---|---|---|---|
| Mean | 69.5 ± 8.2 | 68.9 ± 7.6 | 69.2 ± 7.9 |
| Age, Customized(Participants) | Olaparib 300 mg bd + Abiraterone 1000 mg qd | Placebo bd + Abiraterone 1000 mg qd | Total |
|---|---|---|---|
| <65 | 13 | 17 | 30 |
| >=65 | 41 | 39 | 80 |
| Sex/Gender, Customized(Participants) | Olaparib 300 mg bd + Abiraterone 1000 mg qd | Placebo bd + Abiraterone 1000 mg qd | Total |
|---|---|---|---|
| Male | 54 | 56 | 110 |
| Race/Ethnicity, Customized(Participants) | Olaparib 300 mg bd + Abiraterone 1000 mg qd | Placebo bd + Abiraterone 1000 mg qd | Total |
|---|---|---|---|
| HISPANIC OR LATINO | 0 | 0 | 0 |
| NOT HISPANIC OR LATINO | 54 | 56 | 110 |
| NOT REPORTED | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Olaparib 300 mg bd + Abiraterone 1000 mg qd | Placebo bd + Abiraterone 1000 mg qd | Total |
|---|---|---|---|
| ASIAN | 54 | 56 | 110 |
| Region of Enrollment(Participants) | Olaparib 300 mg bd + Abiraterone 1000 mg qd | Placebo bd + Abiraterone 1000 mg qd | Total |
|---|---|---|---|
| China | 54 | 56 | 110 |
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