An AE was any untoward medical occurrence in a clinical investigation where participant administered a product; the event did not need to have a causal relationship with the treatment. A SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and non-serious AEs.

Safety analysis set: all enrolled participants who received at least one dose of one of the components of the regimen. For this outcome measure, participants are grouped by disease type and treatment, as follows: Cohort All mCRPC Patients (all mCRPC participants), Cohort 1B (BCR with 1 immune checkpoint inhibitor [ICI]), Cohort 5B (BCR with 2 ICIs), and Cohort 7A and 3B Combined (mCRPC at recommended Phase 2 dose [RP2D] dose).

An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. Grades of AEs were defined by NCI CTCAE v 4.03. Grade 1=asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5= death related to AE. Treatment-emergent adverse events occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Safety analysis set: all enrolled participants who received at least one dose of one of the components of the regimen. For this outcome measure, participants are grouped by disease type and treatment, as follows: Cohort All mCRPC Patients (all mCRPC participants), Cohort 1B (BCR with 1 immune checkpoint inhibitor [ICI]), Cohort 5B (BCR with 2 ICIs), and Cohort 7A and 3B Combined (mCRPC at recommended Phase 2 dose [RP2D] dose).

An AE was any untoward medical occurrence in a clinical investigation where participant administered a product; the event did not need to have a causal relationship with the treatment.

Safety analysis set: all enrolled participants who received at least one dose of one of the components of the regimen. or this outcome measure, participants are grouped by disease type and treatment, as follows: Cohort All mCRPC Patients (all mCRPC participants), Cohort 1B (BCR with 1 immune checkpoint inhibitor [ICI]), Cohort 5B (BCR with 2 ICIs), and Cohort 7A and 3B Combined (mCRPC at recommended Phase 2 dose [RP2D] dose).

The following AEs occurring in the first 28 days following the first AdC68 vaccination and not related to disease/progression were DLTs: (a) hematologic (Cohorts 1A to 3A and Cohorts 6A to 9A): Grade 3 neutropenia lasting >7 days, febrile neutropenia, Grade >=3 neutropenic infection, Grade >=3 thrombocytopenia, Grade >=3 anemia lasting >7 days, Grade >=3 lymphopenia lasting >14 days; (b) non-hematologic (all cohorts): Grade >=3 laboratory abnormalities either associated with symptoms or associated with worsening of an existing condition or that suggested a new disease process or that required additional active management, Grade >=3 toxicities, Grade 3 flu like symptoms lasting >3 days, fever of >40.0 degree Celsius lasting >3 days. Other clinically important or persistent toxicities at discretion of investigator and Pfizer.

Per protocol analysis set: all enrolled participants who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 and did not have major protocol deviations during the 28 days after the first vaccination. For this outcome measure, participants are grouped by disease type and treatment, as follows: Cohort All mCRPC Patients (all mCRPC participants), Cohort 1B (BCR with 1 ICI), Cohort 5B (BCR with 2 ICIs), and Cohort 7A and 3B Combined (mCRPC at RP2D dose).

Laboratory abnormalities were graded per NCI CTCAE version 4.03 (Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated) and those with at least 1 participant are presented here. Hematology parameters included hemoglobin, platelets, white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes.

Safety analysis set: all enrolled participants who received at least one dose of one of the components of the regimen. For this outcome measure, participants are grouped by disease type and treatment, as follows: Cohort All mCRPC Patients (all mCRPC participants), Cohort 1B (BCR with 1 ICI), Cohort 5B (BCR with 2 ICIs), and Cohort 7A and 3B Combined (mCRPC at RP2D dose).

Laboratory abnormalities were graded per NCI CTCAE version 4.03 (Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated) and those with at least 1 participant are presented here. Chemistry parameters included aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen (or urea), creatinine, uric acid, glucose, albumin, phosphorous or phosphate, lactate dehydrogenase, lipase, bicarbonate or carbon dioxide, total protein, TSH (if abnormal, reflex free T4 and free T3).

Safety analysis set: all enrolled participants who received at least one dose of one of the components of the regimen. For this outcome measure, participants are grouped by disease type and treatment, as follows: Cohort All mCRPC Patients (all mCRPC participants), Cohort 1B (BCR with 1 ICI), Cohort 5B (BCR with 2 ICIs), and Cohort 7A and 3B Combined (mCRPC at RP2D dose).

Laboratory abnormalities were graded per NCI CTCAE version 4.03 (Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated) and those with at least 1 participant are presented here. Urine parameters included urine protein and urine blood.

Safety analysis set: all enrolled participants who received at least one dose of one of the components of the regimen. For this outcome measure, participants are grouped by disease type and treatment, as follows: Cohort All mCRPC Patients (all mCRPC participants), Cohort 1B (BCR with 1 ICI), Cohort 5B (BCR with 2 ICIs), and Cohort 7A and 3B Combined (mCRPC at RP2D dose).

T cell response to PSA was determined by assaying peripheral blood mononuclear cell (PBMC) samples for cellular immune responses against PSA antigens and was determined as the frequency of interferon-gamma (IFN-γ) spot forming cells (SFC)/million PBMCs. Change from baseline at Cycle 1 Day 71 and at Cycle 2 Day 99 are presented here.

All enrolled participants in Part A who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis. Number of Participants Analyzed = number of participants evaluable for this OM; Number Analyzed = number of participants evaluable for this OM at the time point specified.

T cell response to PSCA was determined by assaying PBMC samples for cellular immune responses against PSCA antigens and was determined as the frequency of IFN-γ SFC/million PBMCs. Change from baseline at Cycle 1 Day 71 and at Cycle 2 Day 99 are presented here.

All enrolled participants in Part A who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis. Number of Participants Analyzed = number of participants evaluable for this OM; Number Analyzed = number of participants evaluable for this OM at the time point specified.

T cell response to PSMA was determined by assaying PBMC samples for cellular immune responses against PSMA antigens and was determined as the frequency of IFN-γ SFC/million PBMCs. Change from baseline at Cycle 1 Day 71 and at Cycle 2 Day 99 are presented here.

All enrolled participants in Part A who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis. Number of Participants Analyzed = number of participants evaluable for this OM; Number Analyzed = number of participants evaluable for this OM at the time point specified.

Cmax was defined as the maximum observed plasma concentration. Blood samples (approximately 3 mL whole blood) to provide at least 1 mL of serum for measurement of tremelimumab PK analysis were collected.

All enrolled participants treated in Part A who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment. Participants in Part 1 Cohort 3A, 6A, 7A, and 9A were treated with tremelimumab, thus included in this outcome measure. Summary statistics for Cohort 6A, 7A, and 9A are not presented since no participants had reportable parameter values.

Tmax was defined as the time to reach maximum observed plasma concentration. Blood samples (approximately 3 mL whole blood) to provide at least 1 mL of serum for measurement of tremelimumab PK analysis were collected.

All enrolled participants treated in Part A who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment. Participants in Part 1 Cohort 3, 6, 7, and 9 were treated with tremelimumab, thus included in this outcome measure. Summary statistics for Cohort 6A, 7A, and 9A are not presented since no participants had reportable parameter values.

AUClast was defined as the area under the curve from time zero to last quantifiable concentration. Blood samples (approximately 3 mL whole blood) to provide at least 1 mL of serum for measurement of tremelimumab PK analysis were collected.

All enrolled participants treated in Part A who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment. Participants in Part 1 Cohort 3A, 6A, 7A, and 9A were treated with tremelimumab, thus included in this outcome measure. Summary statistics for Cohort 6A, 7A, and 9A are not presented since no participants had reportable parameter values.

Pre-dose tremelimumab concentration on Cycle 2 Day 1 is presented here as Ctrough. Blood samples (approximately 3 mL whole blood) to provide at least 1 mL of serum for measurement of tremelimumab PK analysis were collected. Summary statistics of Ctrough were not calculated if number of observations above lower lit of quantification (NALQ)=0 or <=3 participants had non-missing data.

PK parameter analysis population: all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment. Participants in Cohort 3A, 6A, 7A, 9A, 1B, 3B, and 5B were treated with tremelimumab, thus included in this outcome measure. Number of Participants Analyzed = Number of participants who had non-missing data and were evaluable for this OM.

Cmax was defined as the maximum observed plasma concentration. Blood samples (approximately 5 mL) to provide serum for the analysis of PF-06801591 concentrations were collected.

All enrolled participants treated in Part A who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment. Participants in Part 1 Cohort 6A, 7A, and 9A were treated with PF-06801591, thus included in this outcome measure.

Tmax was defined as the time at which Cmax occurred. Blood samples (approximately 5 mL) to provide serum for the analysis of PF- 06801591 concentrations were collected.

All enrolled participants treated in Part A who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment. Participants in Part 1 Cohort 6A, 7A, and 9A were treated with PF-06801591, thus included in this outcome measure.

AUClast was defined as the area under the curve from time zero to last quantifiable concentration. Blood samples (approximately 5 mL) to provide serum for the analysis of PF-06801591 concentrations were collected. The geometric mean and geometric coefficient of variation of AUClast for Cohort 9A were not presented because fewer than 3 participants had reportable parameter values.

All enrolled participants treated in Part A who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment. Participants in Part 1 Cohort 6A, 7A, and 9A were treated with PF-06801591, thus included in this outcome measure.

Pre-dose PF-06801591 concentration on Cycle 2 Day 1 is presented here as Ctrough. Blood samples (approximately 3 mL whole blood) to provide at least 1 mL of serum for measurement of PF-06801591 PK analysis were collected.

PK parameter analysis population: all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment. Participants in Cohort 6A, 7A, 9A, 3B, and 5B were treated with PF-06801591, thus included in this outcome measure.

Blood samples (approximately 5 mL) to provide at least 1 mL of serum to detect ADA were collected from participants enrolled in to Cohorts 3A to 9A and Cohorts 1B to 5B. Participants were considered ADA-positive if sample titer (log10) >=1.48; participants were considered ADA-negative if sample titer (log10) <1.48.

All enrolled participants who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis. For this outcome measure, participants are grouped by disease type and tremelimumab dose, as follows: All mCRPC Patients, All BCR Patients, Cohort 9A (tremelimumab 40 mg), and Cohort 3A, 6A, 7A, 1B, 3B, and 5B Combined (tremelimumab 80 mg).

Treatment-induced ADA was defined as baseline titer missing or negative and participant had >=1 post-treatment positive titer. Blood samples (approximately 5 mL) to provide at least 1 mL of serum to detect ADA were collected from participants enrolled in to Cohorts 3A to 9A and Cohorts 1B to 5B.

All enrolled participants who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis. For this outcome measure, participants are grouped by disease type and tremelimumab dose as follows: All mCRPC Patients, All BCR Patients, Cohort 9A (tremelimumab 40 mg), and Cohort 3A, 6A, 7A, 1B, 3B, and 5B Combined (tremelimumab 80 mg).

Only those samples tested positive for ADA were to be further tested for Nab. Blood samples (approximately 5 mL) to provide at least 1 mL of serum to detect NAb were collected from participants enrolled in to Cohorts 3A to 9A and Cohorts 1B to 5B. Nab against tremelimumab was not examined due to business reason.

All enrolled participants who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis. For this outcome measure, participants are grouped by disease type and tremelimumab dose as follows: All mCRPC Patients, All BCR Patients, Cohort 9A (tremelimumab 40 mg), and Cohort 3A, 6A, 7A, 1B, 3B, and 5B Combined (tremelimumab 80 mg).

Only those samples tested positive for ADA were to be further tested for Nab. Blood samples (approximately 5 mL) to provide at least 1 mL of serum to detect NAb were collected from participants enrolled in to Cohorts 3A to 9A and Cohorts 1B to 5B. Nab against tremelimumab was not examined due to business reason.

All enrolled participants who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis. For this outcome measure, participants are grouped by disease type and tremelimumab dose as follows: All mCRPC Patients, All BCR Patients, Cohort 9A (tremelimumab 40 mg), and Cohort 3A, 6A, 7A, 1B, 3B, and 5B Combined (tremelimumab 80 mg).

Participants were considered ADA-positive if sample titer (log10) >=99; Participants were considered ADA-negative if sample titer (log10) <99. Blood samples (approximately 5 mL) to provide at least 1 mL of serum for detection of ADA against PF-06801591 were collected from participants enrolled in Cohorts 6A to 9A and Cohorts 3B and 5B.

All enrolled participants who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis. For this outcome measure, participants are grouped by disease type and PF-06801591 dose as follows: All mCRPC Patients, All BCR Patients, Cohort 7A and 3B Combined (PF-06801591 300 mg), and Cohort 6A, 9A, and 5B Combined (PF-06801591 130 mg).

Treatment-induced ADA was defined as baseline titer missing or negative and participant had >=1 post-treatment positive titer. Blood samples (approximately 5 mL) to provide at least 1 mL of serum for detection of ADA against PF-06801591 were collected from participants enrolled in Cohorts 6A to 9A and Cohorts 3B and 5B.

All enrolled participants who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis. For this outcome measure, participants are grouped by disease type and PF-06801591 dose, as follows: All mCRPC Patients, All BCR Patients, Cohort 7A and 3B Combined (PF-06801591 300 mg), and Cohort 6A, 9A, and 5B Combined (PF-06801591 130 mg).

Only those samples tested positive for ADA were to be further tested for Nab. Blood samples (approximately 5 mL) to provide at least 1 mL of serum for detection of NAb against PF-06801591 were collected from participants enrolled in Cohorts 6A to 9A and Cohorts 3B and 5B. Nab against PF-06801591 was not examined due to business reason.

All enrolled participants who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis. For this outcome measure, participants are grouped by disease type and PF-06801591 dose, as follows: All mCRPC Patients, All BCR Patients, Cohort 7A and 3B Combined (PF-06801591 300 mg), and Cohort 6A, 9A, and 5B Combined (PF-06801591 130 mg).

Only those samples tested positive for ADA were to be further tested for Nab. Blood samples (approximately 5 mL) to provide at least 1 mL of serum for detection of NAb against PF-06801591 were collected from participants enrolled in Cohorts 6A to 9A and Cohorts 3B and 5B. Nab against PF-06801591 was not examined due to business reason.

All enrolled participants who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis. For this outcome measure, participants are grouped by disease type and PF-06801591 dose, as follows: All mCRPC Patients, All BCR Patients, Cohort 7A and 3B Combined (PF-06801591 300 mg), and Cohort 6A, 9A, and 5B Combined (PF-06801591 130 mg).

ORR was defined as the percentage of participants with best overall response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v1.1. Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm) and no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions.

All enrolled participants in Cohort 1A, 2A, 3A, 6A, 7A, 9A, and 3B who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis.

DOR was defined as the time from first documentation of confirmed CR or PR to date of first documentation of progressive disease (PD) or death due to any cause according to RECIST v1.1. Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm) and no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all measurable target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions. PD was defined as >=20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm. Unequivocal progression of pre existing lesions for non-target disease.

All enrolled participants in Cohort 1A, 2A, 3A, 6A, 7A, 9A, and 3B who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis.

Immune-related confirmed ORR was defined as the percentage of participants with objective response based assessment of confirmed immune related complete response (irCR) or confirmed immune related partial response (irPR) according to irRECIST v1.1. Per irRECIST v1.1: irCR was defined as complete disappearance of all lesions and no new lesions. All measurable lymph nodes also must have a reduction in short axis to <10 mm. irPR was defined as sum of the diameters (longest for non nodal lesions, shortest for nodal lesions) of target and new measurable lesions must decrease >=30%.

All enrolled participants in Cohort 1A, 2A, 3A, 6A, 7A, 9A, and 3B who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis.

Immune-related confirmed DOR was defined as the time from first documentation of confirmed irCR or confirmed irPR to date of first documentation of immune related progressive disease (irPD) or death due to any cause according to irRECIST. Per irRECIST v1.1: irCR was defined as complete disappearance of all lesions and no new lesions. All measurable lymph nodes also must have a reduction in short axis to <10 mm. irPR was defined as sum of the diameters (longest for non nodal lesions, shortest for nodal lesions) of target and new measurable lesions must decrease >=30%. irPD was defined as sum of the diameters of target and new measurable lesions must increase >=20%, confirmed by a repeat, consecutive observation at least 4 weeks from the date first documented.

All enrolled participants in Cohort 1A, 2A, 3A, 6A, 7A, 9A, and 3B who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis.

Number of participants with bone progression per Prostate Cancer Clinical Trials Working Group 3 (PCWG3). Per PCWG3, progressing disease on bone scan was considered when at least two new lesions relative to the first post treatment scan was confirmed on a subsequent scan (6 or more weeks later).

All enrolled participants in Cohort 7A and 3B who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis.

Radiographic Progression Free Survival (rPFS) per RECIST v1.1. rPFS was defined as the time from first dose of study treatment to date of first documentation of radiographic PD or death due to any cause, whichever occurs first. Per RECIST v1.1, PD was defined as >=20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm. Unequivocal progression of pre existing lesions for non-target disease. The Kaplan Meier estimate of median rPFS was presented here.

All enrolled participants who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis.

PSA-50 response rate was defined as the proportion of patients whose on-study PSA declined from baseline by at least 50% at two consecutive measurements at least 3 weeks apart, prior to other systematic anti-cancer therapy.

All enrolled participants in Part B who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis.

Duration of PSA-50 response was defined as the period from the first measurement when PSA-50 response was achieved to the measurement when PSA-50 response no longer held.

All enrolled participants in Part B who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis.

PSA Baseline is defined as the most recent non-missing value prior to dosing.

All enrolled participants in Part B who received at least one dose of one of the components of the regimen.

PSADT was defined as the natural log of 2 divided by the slope of the linear regression line of the natural log of PSA against time in month. Baseline has been calculated from the PSA values at screening and C1D1.

All enrolled participants in Part B who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis.

PSA slope was defined as the slope of the linear regression line of natural log of PSA against time in month. Baseline has been calculated from the PSA values at screening and C1D1.

All enrolled participants in Part B who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis.

PSA velocity was defined as the slope of the linear regression line of PSA against time in month. Baseline has been calculated from the PSA values at screening and C1D1.

All enrolled participants in Part B who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis.

PSADT was defined as the natural log of 2 divided by the slope of the linear regression line of the natural log of PSA against time in month. PSADT at the post-treatment visit was calculated from C1D1 and all post-treatment PSA values.

All enrolled participants in Part B who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis.

PSA slope was defined as the slope of the linear regression line of natural log of PSA against time in month. PSA slope at the post-treatment visit was calculated from C1D1 and all post-treatment PSA values.

All enrolled participants in Part B who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis.

PSA velocity was defined as the slope of the linear regression line of PSA against time in month. PSA velocity at the post-treatment visit was calculated from C1D1 and all post-treatment PSA values.

All enrolled participants in Part B who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis.