Trial · NCT03072238

Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer

NCT03072238, Phase 3, Completed, Hoffmann-La Roche; results first posted 2023-04-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer. Trials, record NCT03072238. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03072238

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer
NCT number: NCT03072238
Status: Completed
Phases: Phase 3
Enrollment: 1,101 participants, actual
Lead sponsor: Hoffmann-La Roche
Conditions: Metastatic Prostate Cancer
Interventions: Ipatasertib, Abiraterone, Placebo, Prednisone/Prednisolone
First posted: 2017-03-07
Last updated: 2025-06-06
Other registries' IDs: eudract:2016-004429-17
Results first posted: 2023-04-10

Source ClinicalTrials.gov

Registered outcomes26

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Investigator-assessed Radiographic Progression-free Survival (rPFS), Per Prostate Cancer Working Group 3 (PCWG3) Criteria in Phosphatase and Tensin Homolog (PTEN) Loss Population	Up to approximately 32 months	rPFS was defined as time from date of randomization to the first occurrence of documented disease progression (PD), as assessed by the investigator with use of the PCWG3 criteria or death from any cause, whichever occurs first. PD for soft tissue was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 millimeters (mm) in the SOD of target lesions; progression of non-target lesions; the appearance of one or more new lesions according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) criteria. PD for bone lesions was defined as 2 or more new lesions compared to baseline followed by a confirmatory bone scan at least 6 weeks later according to the PCWG3 criteria. The Kaplan-Meier (KM) estimate was used to determine the median rPFS.
Primary	Investigator-assessed rPFS, Per PCWG3 Criteria in ITT Population	Up to approximately 32 months	rPFS was defined as time from date of randomization to the first occurrence of documented PD, as assessed by the investigator with use of the PCWG3 criteria or death from any cause, whichever occurs first. PD for soft tissue was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm in the SOD of target lesions; progression of non-target lesions; the appearance of one or more new lesions according to RECIST v1.1 criteria. PD for bone lesions was defined as 2 or more new lesions compared to baseline followed by a confirmatory bone scan at least 6 weeks later according to the PCWG3 criteria. The KM estimate was used to determine the median rPFS.
Secondary	Overall Survival (OS) in PTEN-loss Population	Up to approximately 6.5 years	OS was defined as the time from randomization to death due to any cause. KM estimates were used to determine the median OS.
Secondary	OS in ITT Population	Up to approximately 6.5 years	OS was defined as the time from randomization to death due to any cause. KM estimates were used to determine the median OS.
Secondary	Time to Pain Progression in PTEN-loss Population	Up to approximately 5.5 years	Time to pain progression was defined as the time from randomization to the first occurrence of confirmed clinically meaningful cancer-related pain progression event. Cancer-related pain progression refers to pain onset for participants who were asymptomatic at baseline or pain worsening for those who were mildly symptomatic at baseline. Pain severity was graded on a 10-point numeric rating scale \[NRS\], with 0=no pain and 10=severe pain. Pain severity progression was defined as a ≥ 2-point absolute increase from baseline. KM estimates were used to determine the median time to pain progression.
Secondary	Time to Pain Progression in ITT Population	Up to approximately 5.5 years	Time to pain progression was defined as the time from randomization to the first occurrence of confirmed clinically meaningful cancer-related pain progression event. Cancer-related pain progression refers to pain onset for participants who were asymptomatic at baseline or pain worsening for those who were mildly symptomatic at baseline. Pain severity was graded on a 10-point NRS, with 0=no pain and 10=severe pain. Pain severity progression was defined as a ≥ 2-point absolute increase from baseline. KM estimates were used to determine the median time to pain progression.
Secondary	Time to Initiation of Cytotoxic Chemotherapy for Prostate Cancer (PC) in PTEN-loss Population	Up to approximately 5.5 years	Time to initiation of cytotoxic chemotherapy was defined as the time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy (use of antineoplastic agents: docetaxel, cabazitaxel, mitoxantrone, estramustine, cisplatin, carboplatin, cyclophosphamide, doxorubicin, mitomycin, irinotecan, 5-fluorouracil, gemcitabine, or etoposide) for PC. KM estimates were used to determine the median time to initiation of cytotoxic chemotherapy.
Secondary	Time to Initiation of Cytotoxic Chemotherapy for PC in ITT Population	Up to approximately 5.5 years	Time to initiation of cytotoxic chemotherapy was defined as the time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy (use of antineoplastic agents: docetaxel, cabazitaxel, mitoxantrone, estramustine, cisplatin, carboplatin, cyclophosphamide, doxorubicin, mitomycin, irinotecan, 5-fluorouracil, gemcitabine, or etoposide) for PC. KM estimates were used to determine the median time to initiation of cytotoxic chemotherapy.
Secondary	Time to Function Deterioration Per European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Physical Function (PF) Scale and Role Function (RF) Scale in PTEN-loss Population	Up to approximately 5.5 years	Time to function deterioration=time from date of randomization to date of 10-point or more score decrease on either EORTC QLQ-C30 5-item PF/2-item RF scale scores, held for two consecutive assessments or death within 28 days, whichever occurs first. EORTC QLQ-C30 consists of 30 questions that assess 5 aspects of participant functioning (physical,emotional,role,cognitive\&social), 3 symptom scales (fatigue,nausea\&vomiting,pain), global health/quality of life (GHS/QoL)\&6 single items (dyspnea,insomnia,appetite loss,constipation,diarrhea\&financial difficulties). PF scale has 5 questions about participants physical functioning\&daily activities. RF scale has 2 questions about work/daily activities\&hobbies/leisurely activities. PF\&RF are scored on a 4-point scale (1=Not at All to 4=Very Much). Obtained scores are linearly transformed to score range of 0-100, where higher scores indicate a higher response level (better PF)\&better functioning/support.
Secondary	Time to Function Deterioration Per EORTC QLQ-C30 PF Scale and RF Scale in ITT Population	Up to approximately 5.5 years	Time to function deterioration=time from date of randomization to date of 10-point or more score decrease on either EORTC QLQ-C30 5-item PF/2-item RF scale scores, held for two consecutive assessments or death within 28 days, whichever occurs first. EORTC QLQ-C30 consists of 30 questions that assess 5 aspects of participant functioning (physical,emotional,role,cognitive \& social), 3 symptom scales (fatigue,nausea\&vomiting,pain), GHS/QoL \& 6 single items (dyspnea,insomnia,appetite loss,constipation,diarrhea \& financial difficulties). PF scale has 5 questions about participants physical functioning \& daily activities. RF scale has 2 questions about work/daily activities \& hobbies/leisurely activities. PF\&RF are scored on a 4-point scale (1=Not at All to 4=Very Much). Obtained scores are linearly transformed to score range of 0-100, where higher scores indicate a higher response level (better PF) \& better functioning/support.

1 to 10 of 26Source ClinicalTrials.gov

See all 26 registered outcomes

Outcomes26

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Investigator-assessed Radiographic Progression-free Survival (rPFS), Per Prostate Cancer Working Group 3 (PCWG3) Criteria in Phosphatase and Tensin Homolog (PTEN) Loss Population	Up to approximately 32 months	PTEN loss population included all randomized participants with PTEN loss tumors by immunohistochemistry (IHC), regardless of whether or not the participant received the assigned treatment.	months	MEDIAN
PRIMARY	Investigator-assessed rPFS, Per PCWG3 Criteria in ITT Population	Up to approximately 32 months	ITT population included all randomized participants, whether or not the participants received the assigned treatment.	months	MEDIAN
SECONDARY	Overall Survival (OS) in PTEN-loss Population	Up to approximately 6.5 years	PTEN loss population included all randomized participants with PTEN loss tumors by IHC, regardless of whether or not the participant received the assigned treatment.	months	MEDIAN
SECONDARY	OS in ITT Population	Up to approximately 6.5 years	ITT population included all randomized participants, whether or not the participants received the assigned treatment.	months	MEDIAN
SECONDARY	Time to Pain Progression in PTEN-loss Population	Up to approximately 5.5 years	PTEN loss population included all randomized participants with PTEN loss tumors by IHC, regardless of whether or not the participant received the assigned treatment.	months	MEDIAN
SECONDARY	Time to Pain Progression in ITT Population	Up to approximately 5.5 years	ITT population included all randomized participants, whether or not the participants received the assigned treatment.	months	MEDIAN
SECONDARY	Time to Initiation of Cytotoxic Chemotherapy for Prostate Cancer (PC) in PTEN-loss Population	Up to approximately 5.5 years	PTEN loss population included all randomized participants with PTEN loss tumors by IHC, regardless of whether or not the participant received the assigned treatment.	months	MEDIAN
SECONDARY	Time to Initiation of Cytotoxic Chemotherapy for PC in ITT Population	Up to approximately 5.5 years	ITT population included all randomized participants, whether or not the participants received the assigned treatment.	months	MEDIAN
SECONDARY	Time to Function Deterioration Per European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Physical Function (PF) Scale and Role Function (RF) Scale in PTEN-loss Population	Up to approximately 5.5 years	PTEN loss population included all randomized participants with PTEN loss tumors by IHC, regardless of whether or not the participant received the assigned treatment.	months	MEDIAN
SECONDARY	Time to Function Deterioration Per EORTC QLQ-C30 PF Scale and RF Scale in ITT Population	Up to approximately 5.5 years	ITT population included all randomized participants, whether or not the participants received the assigned treatment.	months	MEDIAN

1 to 10 of 26Source ClinicalTrials.gov

See all 26 outcomes

Results by group58

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Investigator-assessed Radiographic Progression-free Survival (rPFS), Per Prostate Cancer Working Group 3 (PCWG3) Criteria in Phosphatase and Tensin Homolog (PTEN) Loss Population	Pbo + Abi	16.5	95% Confidence Interval 13.9 to 17.0	months
Investigator-assessed Radiographic Progression-free Survival (rPFS), Per Prostate Cancer Working Group 3 (PCWG3) Criteria in Phosphatase and Tensin Homolog (PTEN) Loss Population	Ipat + Abi	18.5	95% Confidence Interval 16.3 to 22.1	months
Investigator-assessed rPFS, Per PCWG3 Criteria in ITT Population	Pbo + Abi	16.6	95% Confidence Interval 15.6 to 19.1	months
Investigator-assessed rPFS, Per PCWG3 Criteria in ITT Population	Ipat + Abi	19.2	95% Confidence Interval 16.5 to 22.3	months
Overall Survival (OS) in PTEN-loss Population	Pbo + Abi	35.8	95% Confidence Interval 30.8 to 39.6	months
Overall Survival (OS) in PTEN-loss Population	Ipat + Abi	36.8	95% Confidence Interval 31.4 to 42.1	months
OS in ITT Population	Pbo + Abi	36.5	95% Confidence Interval 33.9 to 39.4	months
OS in ITT Population	Ipat + Abi	39.4	95% Confidence Interval 36.5 to 42.9	months
Time to Pain Progression in PTEN-loss Population	Pbo + Abi	17.6	95% Confidence Interval 14.6 to 27.7	months
Time to Pain Progression in PTEN-loss Population	Ipat + Abi	25.8	95% Confidence Interval 17.5 to 43.3	months

1 to 10 of 58Source ClinicalTrials.gov

See all 58 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pbo + Abi	554
Overall Study	STARTED	Ipat + Abi	547
Overall Study	Safety Evaluable (SE) Population	Pbo + Abi	546
Overall Study	Safety Evaluable (SE) Population	Ipat + Abi	551
Overall Study	COMPLETED	Pbo + Abi	0
Overall Study	COMPLETED	Ipat + Abi	0
Overall Study	NOT COMPLETED	Pbo + Abi	554
Overall Study	NOT COMPLETED	Ipat + Abi	547

Source ClinicalTrials.gov

Adverse events638

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Pbo + Abi	75	546	107
other	Anaemia	Blood and lymphatic system disorders	Ipat + Abi	127	551	192
other	Abdominal pain	Gastrointestinal disorders	Pbo + Abi	22	546	24
other	Abdominal pain	Gastrointestinal disorders	Ipat + Abi	32	551	38
other	Constipation	Gastrointestinal disorders	Pbo + Abi	95	546	111
other	Constipation	Gastrointestinal disorders	Ipat + Abi	55	551	60
other	Diarrhoea	Gastrointestinal disorders	Pbo + Abi	137	546	193
other	Diarrhoea	Gastrointestinal disorders	Ipat + Abi	441	551	969
other	Dyspepsia	Gastrointestinal disorders	Pbo + Abi	27	546	33
other	Dyspepsia	Gastrointestinal disorders	Ipat + Abi	37	551	40

1 to 10 of 638Source ClinicalTrials.gov

See all 638 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pbo + Abi	358	546
Total, all-cause mortality	Ipat + Abi	331	551
Total, other adverse events	Pbo + Abi	496	546
Total, other adverse events	Ipat + Abi	541	551
Total, serious adverse events	Pbo + Abi	158	546
Total, serious adverse events	Ipat + Abi	252	551

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34246347	DERIVED	PubMed
36305957	DERIVED	PubMed
36697317	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Pbo + Abi vs Ipat + Abi: deaths from any cause	Trial comparisons
Pbo + Abi vs Ipat + Abi: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03072238

GET https://conductscience.org/api/trials/v1/NCT03072238/registered?page=2

API reference For AI assistants