Trial Outcomes & Findings for A Study of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC. (NCT NCT04495179)

Last Updated: 2023-08-09

Results Overview

rPFS was defined as the time from first dose to radiographic progression, assessed by the Investigator per RECIST 1.1 (soft tissue) and PCWG3 (Prostate Cancer Working Group 3) criteria \[bone\] or death from any cause, whichever occurred first.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

From first dose to first documented progression or death from any cause (whichever comes first) (approximately 1 year)

Results posted on

2023-08-09

Participant Flow

Participants were enrolled in this study from 04-August-2020 to 08-August-2022.

Participants who met the inclusion and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the schedule of assessment.

Participant milestones

Participant milestones
Measure	Arm A: AZD4635 + Durvalumab Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.	Arm B: AZD4635 + Durvalumab + Cabazitaxel Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
Overall Study STARTED	2	28
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	2	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: AZD4635 + Durvalumab Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.	Arm B: AZD4635 + Durvalumab + Cabazitaxel Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	2	4
Overall Study Study terminated by sponsor	0	18
Overall Study Death	0	4
Overall Study Adverse Event	0	1

Baseline Characteristics

The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: AZD4635 + Durvalumab n=2 Participants Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.	Arm B: AZD4635 + Durvalumab + Cabazitaxel n=28 Participants Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W	Total n=30 Participants Total of all reporting groups
Age, Continuous	—	68.0 years STANDARD_DEVIATION 8.18 • n=28 Participants • The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.	68.0 years STANDARD_DEVIATION 8.18 • n=28 Participants • The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
Sex/Gender, Customized Male	0 Participants The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.	28 Participants n=28 Participants • The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.	28 Participants n=28 Participants • The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants The number analyzed in the row differs from the overall value as efficacy for low number of participants were not presented.	4 Participants n=28 Participants • The number analyzed in the row differs from the overall value as efficacy for low number of participants were not presented.	4 Participants n=28 Participants • The number analyzed in the row differs from the overall value as efficacy for low number of participants were not presented.
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants The number analyzed in the row differs from the overall value as efficacy for low number of participants were not presented.	21 Participants n=28 Participants • The number analyzed in the row differs from the overall value as efficacy for low number of participants were not presented.	21 Participants n=28 Participants • The number analyzed in the row differs from the overall value as efficacy for low number of participants were not presented.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants The number analyzed in the row differs from the overall value as efficacy for low number of participants were not presented.	3 Participants n=28 Participants • The number analyzed in the row differs from the overall value as efficacy for low number of participants were not presented.	3 Participants n=28 Participants • The number analyzed in the row differs from the overall value as efficacy for low number of participants were not presented.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.	0 Participants n=25 Participants • The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.	0 Participants n=25 Participants • The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
Race (NIH/OMB) Asian	0 Participants The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.	5 Participants n=25 Participants • The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.	5 Participants n=25 Participants • The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.	0 Participants n=25 Participants • The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.	0 Participants n=25 Participants • The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
Race (NIH/OMB) Black or African American	0 Participants The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.	0 Participants n=25 Participants • The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.	0 Participants n=25 Participants • The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
Race (NIH/OMB) White	0 Participants The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.	19 Participants n=25 Participants • The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.	19 Participants n=25 Participants • The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
Race (NIH/OMB) More than one race	0 Participants The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.	0 Participants n=25 Participants • The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.	0 Participants n=25 Participants • The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
Race (NIH/OMB) Unknown or Not Reported	0 Participants The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.	1 Participants n=25 Participants • The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.	1 Participants n=25 Participants • The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.

PRIMARY outcome

Timeframe: From first dose to first documented progression or death from any cause (whichever comes first) (approximately 1 year)

Population: Evaluable for efficacy set consisted of dosed patients with a baseline tumour assessment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.

Outcome measures

Outcome measures
Measure	Arm A: AZD4635 + Durvalumab Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.	Arm B: AZD4635 + Durvalumab + Cabazitaxel n=28 Participants Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
Radiographic Progression Free Survival (rPFS) in Each Arm Separately to Determine the Efficacy of AZD4635 Plus Durvalumab and of AZD4635 Plus Durvalumab Plus Cabazitaxel in Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC)	—	5.8 months Interval 4.2 to An upper limit for the 95%CI was not calculated because there were not enough events at later times to get a reliable upper CI.

SECONDARY outcome

Timeframe: From first dose to first documented progression or death from any cause (whichever comes first), up to two years

rPFS was defined as the time from first dose to radiographic progression, assessed by the Investigator per RECIST 1.1 (soft tissue) and PCWG3 criteria (bone) or death from any cause, whichever occurred first.

Outcome measures

Outcome measures
Measure	Arm A: AZD4635 + Durvalumab Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.	Arm B: AZD4635 + Durvalumab + Cabazitaxel n=27 Participants Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
rPFS by Adenosine (ADO) Signalling Gene Expression in High and Low Subgroups to Determine the Efficacy of AZD4635 Plus Durvalumab Plus Cabazitaxel in Participants With mCRPC High ADO	—	14 Participants
rPFS by Adenosine (ADO) Signalling Gene Expression in High and Low Subgroups to Determine the Efficacy of AZD4635 Plus Durvalumab Plus Cabazitaxel in Participants With mCRPC Low ADO	—	13 Participants

SECONDARY outcome

Timeframe: Arm A and B: Every 90 days from the last dose of study drug up to 2 years

OS was defined as the time from first dose until death due to any cause regardless of whether the participant withdrew from study treatment or received another anti-cancer therapy.

Outcome measures

Outcome measures
Measure	Arm A: AZD4635 + Durvalumab Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.	Arm B: AZD4635 + Durvalumab + Cabazitaxel n=28 Participants Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
Overall Survival (OS) in Each Arm Separately to Determine the Efficacy of AZD4635 Plus Durvalumab and of AZD4635 Plus Durvalumab Plus Cabazitaxel in Participants With mCRPC	—	NA months Interval 7.9 to This value was not calculated since less than 50% patients died during the study.

SECONDARY outcome

Timeframe: From first dose to first documented progression or death from any cause (whichever comes first), up to two years

Confirmed ORR was defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) using overall radiographic response assessed by RECIST v1.1 and PCWG-3 criteria (bone), and was based on a subset of all treated participants with measurable disease at baseline per the site Investigator.

Outcome measures

Outcome measures
Measure	Arm A: AZD4635 + Durvalumab Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.	Arm B: AZD4635 + Durvalumab + Cabazitaxel n=28 Participants Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
Number of Participants With Objective Response in Subjects With MCRPC Who Received AZD4635 Plus Durvalumab Plus Cabazitaxel	—	2 Participants Interval 0.88 to 23.5

SECONDARY outcome

Timeframe: Arm A: Screening, Day 1 of each cycle up to 11 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 11 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)

Population: PSA evaluable analysis set consisted of dosed participants with an abnormal baseline PSA (=1ng/mL). The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.

Confirmed PSA50 response is defined as the proportion of participants who achieved a ≥50% decrease in PSA from baseline to the lowest post-baseline PSA, confirmed by a consecutive PSA at least 3 weeks later and was based on PSA evaluable participants (dosed participants with an abnormal baseline PSA \[≥1 ng/mL\]).

Outcome measures

Outcome measures
Measure	Arm A: AZD4635 + Durvalumab Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.	Arm B: AZD4635 + Durvalumab + Cabazitaxel n=28 Participants Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
Number of Participants With Prostate-specifin Antigen (PSA50) Response in Subjects With MCRPC Who Received AZD4635 Plus Durvalumab Plus Cabazitaxel	—	5 Participants Interval 0.06 to 0.37

SECONDARY outcome

Timeframe: Arm A: Screening, Day 1 of each cycle up to 9 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 9 months (Each cycle was 21 days in length)

Population: Full analysis set consisted of all participants who received at least one (non-zero) dose of study treatment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk. Only safety data have been provided. None of the 14 participants at Baseline answered the questionnaire at Cycle 1 Day 1. Therefore, related statistics were not derived for this timepoint.

"Worst pain" and "Average pain" are 'single question' scores from the BPI short form and may take any value from 0 to 10 (worst outcome). "Interference Pain" is the total score of 7 sub-scores, where each value may take any value from 0 to 10 (worst outcome). The range of the "Interference Score" can be from 0 to 70.

Outcome measures

Outcome measures
Measure	Arm A: AZD4635 + Durvalumab Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.	Arm B: AZD4635 + Durvalumab + Cabazitaxel n=28 Participants Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
Change From Baseline in Worst Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Baseline	—	3.4 Score on a Scale Standard Deviation 2.44
Change From Baseline in Worst Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Cycle 2 Day 1	—	-1.6 Score on a Scale Standard Deviation 2.94
Change From Baseline in Worst Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Cycle 3 Day 1	—	-0.3 Score on a Scale Standard Deviation 4.40
Change From Baseline in Worst Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Cycle 4 Day 1	—	-1.6 Score on a Scale Standard Deviation 2.88
Change From Baseline in Worst Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Cycle 5 Day 1	—	-2.1 Score on a Scale Standard Deviation 3.58
Change From Baseline in Worst Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Cycle 6 Day 1	—	-1.9 Score on a Scale Standard Deviation 3.00
Change From Baseline in Worst Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Cycle 7 Day 1	—	1.0 Score on a Scale Standard Deviation 1.85
Change From Baseline in Worst Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Cycle 8 Day 1	—	-1.7 Score on a Scale Standard Deviation 2.66
Change From Baseline in Worst Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Cycle 9 Day 1	—	-0.2 Score on a Scale Standard Deviation 2.17

SECONDARY outcome

Timeframe: Arm A: Screening, Day 1 of each cycle up to 9 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 9 months (Each cycle was 21 days in length)

Population: Full analysis set consisted of all participants who received at least one (non-zero) dose of study treatment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk. Only safety data have been provided. None of the 14 participants at Baseline answered the questionnaire at Cycle 1 Day 1 and, therefore, related statistics were not derived for this timepoint.

Outcome measures

Outcome measures
Measure	Arm A: AZD4635 + Durvalumab Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.	Arm B: AZD4635 + Durvalumab + Cabazitaxel n=28 Participants Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
Change From Baseline in Average Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Baseline	—	2.3 Score on a Scale Standard Deviation 2.09
Change From Baseline in Average Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Cycle 2 Day 1	—	-1.3 Score on a Scale Standard Deviation 1.19
Change From Baseline in Average Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Cycle 3 Day 1	—	0.6 Score on a Scale Standard Deviation 3.15
Change From Baseline in Average Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Cycle 4 Day 1	—	-0.9 Score on a Scale Standard Deviation 1.27
Change From Baseline in Average Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Cycle 5 Day 1	—	-1.6 Score on a Scale Standard Deviation 2.15
Change From Baseline in Average Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Cycle 6 Day 1	—	-1.4 Score on a Scale Standard Deviation 1.51
Change From Baseline in Average Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Cycle 7 Day 1	—	0.0 Score on a Scale Standard Deviation 1.41
Change From Baseline in Average Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Cycle 8 Day 1	—	-0.8 Score on a Scale Standard Deviation 1.47
Change From Baseline in Average Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Cycle 9 Day 1	—	-1.2 Score on a Scale Standard Deviation 0.84

SECONDARY outcome

Timeframe: Arm A: Screening, Day 1 of each cycle up to 9 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 9 months (Each cycle was 21 days in length)

Population: Full analysis set consisted of all participants who received at least one (non-zero) dose of study treatment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk. Only safety data have been provided. None of the 14 participants at Baseline answered the questionnaire at Cycle 1 Day 1 and, therefore, related statistics were not derived for this timepoint.

Outcome measures

Outcome measures
Measure	Arm A: AZD4635 + Durvalumab Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.	Arm B: AZD4635 + Durvalumab + Cabazitaxel n=28 Participants Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
Change From Baseline in Pain Interference in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Cycle 8 Day 1	—	7.2 Score on a Scale Standard Deviation 13.98
Change From Baseline in Pain Interference in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Baseline	—	8.0 Score on a Scale Standard Deviation 8.47
Change From Baseline in Pain Interference in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Cycle 2 Day 1	—	2.5 Score on a Scale Standard Deviation 13.90
Change From Baseline in Pain Interference in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Cycle 3 Day 1	—	12.3 Score on a Scale Standard Deviation 18.96
Change From Baseline in Pain Interference in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Cycle 4 Day 1	—	4.9 Score on a Scale Standard Deviation 12.73
Change From Baseline in Pain Interference in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Cycle 5 Day 1	—	1.3 Score on a Scale Standard Deviation 5.19
Change From Baseline in Pain Interference in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Cycle 6 Day 1	—	2.0 Score on a Scale Standard Deviation 8.40
Change From Baseline in Pain Interference in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Cycle 7 Day 1	—	8.1 Score on a Scale Standard Deviation 9.93
Change From Baseline in Pain Interference in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF) Cycle 9 Day 1	—	5.4 Score on a Scale Standard Deviation 15.16

SECONDARY outcome

Timeframe: Arm A: Screening, Day 1 of each cycle up to 12 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 12 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)

Pain progression was assessed using BPI-SF.

Outcome measures

Outcome measures
Measure	Arm A: AZD4635 + Durvalumab Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.	Arm B: AZD4635 + Durvalumab + Cabazitaxel n=28 Participants Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
Number of Participants Who Progressed Based on BPI-SF Item 3	—	1 Participants

SECONDARY outcome

Timeframe: Arm A: Screening, Day 1 of each cycle up to 9 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 9 months (Each cycle was 21 days in length)

Population: Full analysis set consisted of all participants who received at least one (non-zero) dose of study treatment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk. None of the 10 participants at Baseline answered the questionnaire at Cycle 1 Day 1. Therefore, related statistics were not derived for this timepoint.

The Functional Assessment of Cancer Therapy-Prostate (FACT-P) will be used to measure health related quality of life (HRQL) in men with prostate cancer. It consists of 4 subscales (physical, emotional, functional and social/family well-being) plus a 12-item prostate-specific module, the PCS subscale, which highlights concerns specific to participants with prostate cancer. FAPSI-6 is defined as a symptom score made up of 6 items from within the FACT-P (pain \[n = 3\], fatigue \[n = 1\], weight loss \[n = 1\], and concerns about the condition getting worse \[n = 1\]). Each question in the FACT-P questionnaires has a choice of 5 responses, "Not at all", "A little bit", "Somewhat", "Quite a bit" and "Very much". The scores range from 0 ("Not at all") to 4 ("Very much") for positively phrased questions. Negatively phrased questions have a reverse scoring, from 0 ("Very much") to 4 ("Not at all"). This results in a consistent approach, where higher scores indicate a better quality of life.

Outcome measures

Outcome measures
Measure	Arm A: AZD4635 + Durvalumab Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.	Arm B: AZD4635 + Durvalumab + Cabazitaxel n=28 Participants Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
Change From Baseline in the FACT Advanced Prostate Symptom Indext-6 (FAPSI-6), as Derived From 6 Items, the FAPSI-8 From 8 Items Within the FACT-P and the Prostate Cancer Symptoms (PCS), From the 12 Items in the Prostrate-specific Module of the FACT-P Baseline	—	16.6 Score on a Scale Standard Deviation 2.88
Change From Baseline in the FACT Advanced Prostate Symptom Indext-6 (FAPSI-6), as Derived From 6 Items, the FAPSI-8 From 8 Items Within the FACT-P and the Prostate Cancer Symptoms (PCS), From the 12 Items in the Prostrate-specific Module of the FACT-P Cycle 2 Day 1	—	1.9 Score on a Scale Standard Deviation 1.68
Change From Baseline in the FACT Advanced Prostate Symptom Indext-6 (FAPSI-6), as Derived From 6 Items, the FAPSI-8 From 8 Items Within the FACT-P and the Prostate Cancer Symptoms (PCS), From the 12 Items in the Prostrate-specific Module of the FACT-P Cycle 3 Day 1	—	-0.7 Score on a Scale Standard Deviation 5.52
Change From Baseline in the FACT Advanced Prostate Symptom Indext-6 (FAPSI-6), as Derived From 6 Items, the FAPSI-8 From 8 Items Within the FACT-P and the Prostate Cancer Symptoms (PCS), From the 12 Items in the Prostrate-specific Module of the FACT-P Cycle 4 Day 1	—	-0.1 Score on a Scale Standard Deviation 3.34
Change From Baseline in the FACT Advanced Prostate Symptom Indext-6 (FAPSI-6), as Derived From 6 Items, the FAPSI-8 From 8 Items Within the FACT-P and the Prostate Cancer Symptoms (PCS), From the 12 Items in the Prostrate-specific Module of the FACT-P Cycle 5 Day 1	—	0.6 Score on a Scale Standard Deviation 3.36
Change From Baseline in the FACT Advanced Prostate Symptom Indext-6 (FAPSI-6), as Derived From 6 Items, the FAPSI-8 From 8 Items Within the FACT-P and the Prostate Cancer Symptoms (PCS), From the 12 Items in the Prostrate-specific Module of the FACT-P Cycle 6 Day 1	—	1.5 Score on a Scale Standard Deviation 1.38
Change From Baseline in the FACT Advanced Prostate Symptom Indext-6 (FAPSI-6), as Derived From 6 Items, the FAPSI-8 From 8 Items Within the FACT-P and the Prostate Cancer Symptoms (PCS), From the 12 Items in the Prostrate-specific Module of the FACT-P Cycle 7 Day 1	—	0.0 Score on a Scale Standard Deviation 3.92
Change From Baseline in the FACT Advanced Prostate Symptom Indext-6 (FAPSI-6), as Derived From 6 Items, the FAPSI-8 From 8 Items Within the FACT-P and the Prostate Cancer Symptoms (PCS), From the 12 Items in the Prostrate-specific Module of the FACT-P Cycle 8 Day 1	—	-1.8 Score on a Scale Standard Deviation 4.15
Change From Baseline in the FACT Advanced Prostate Symptom Indext-6 (FAPSI-6), as Derived From 6 Items, the FAPSI-8 From 8 Items Within the FACT-P and the Prostate Cancer Symptoms (PCS), From the 12 Items in the Prostrate-specific Module of the FACT-P Cycle 9 Day 1	—	-3.0 Score on a Scale Standard Deviation 4.55

SECONDARY outcome

Timeframe: Arm A:Cycle 1 to 3, and Cycle 4 onwards, and 90-day follow-up (FU) visit up to 14 months [Each cycle was 28 days in length];Arm B: Cycle 1 to 7 and Cycle 11 onwards, and 90-day FU up to 14 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)

Population: The pharmacokinetics (PK) analysis set consisted of dosed participants for whom an adequate PK profile was obtained. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.

Investigate the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.

Outcome measures

Outcome measures
Measure	Arm A: AZD4635 + Durvalumab Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.	Arm B: AZD4635 + Durvalumab + Cabazitaxel n=15 Participants Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
Maximum Observed Plasma Concentration (Cmax)	—	483.0 nanogram/millilitre (ng/mL) Standard Deviation 231.1

SECONDARY outcome

Population: The PK analysis set consisted of dosed participants for whom an adequate PK profile was obtained. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.