Trial · NCT03279250

Apalutamide and Gonadotropin-Releasing Hormone Analog With or Without Abiraterone Acetate in Treating Participants With Prostate Cancer

NCT03279250, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2022-08-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Apalutamide and Gonadotropin-Releasing Hormone Analog With or Without Abiraterone Acetate in Treating Participants With Prostate Cancer. Trials, record NCT03279250. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03279250

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Trial

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

Title: Apalutamide and Gonadotropin-Releasing Hormone Analog With or Without Abiraterone Acetate in Treating Participants With Prostate Cancer
NCT number: NCT03279250
Status: Completed
Phases: Phase 2
Enrollment: 86 participants, actual
Lead sponsor: M.D. Anderson Cancer Center
Conditions: Prostate Adenocarcinoma, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8
Interventions: Abiraterone Acetate, Apalutamide, Gonadotropin-releasing Hormone Analog, Prednisone, Radical Prostatectomy
First posted: 2017-09-12
Last updated: 2022-08-10
Results first posted: 2022-08-10

Source ClinicalTrials.gov

Registered outcomes10

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

List	Outcome	Time frame	Description
Primary	The Number of Participants With Rate of Pathologic Stage =< pT2N0 at Prostatectomy	At the time of radical prostatectomy	The study will provide a point estimate and 95% confidence interval of the proportion of patients with pathologic stage =\< pT2N0 at prostatectomy for each arm. Patient characteristics will be summarized using descriptive statistics for each arm.
Secondary	Number of Participants With Incidence of Adverse Events	From screening up to 4 weeks post-surgery, an average of 7 months	Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Incidence of serious adverse events and 95% confidence interval will be provided overall as well as for each major affected organ category.
Secondary	Tumor Epithelium Volume in the Surgical Specimen	At the time of radical prostatectomy	Tumor volume will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Secondary categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.
Secondary	Assessment of Positive Surgical Margins in the Surgical Specimen	At the time of radical prostatectomy	Presence of positive surgical margins will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Secondary categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.
Secondary	Time to Prostate Specific Antigen Recurrence (TTRPSA)	From the date of randomization up to 4 weeks post-surgery	TTRPSA will be summarized by Kaplan-Meier estimates and confidence intervals. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Secondary categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.
Other	Assessment of Steroid Hormone Metabolome in Blood Plasma and Tissue	At radical prostatectomy	Steroid hormone metabolome in blood plasma and tissue will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Exploratory categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.
Other	Assessment of Protein and Ribonucleic Acid (RNA) Analysis Results	At radical prostatectomy	Assessment of protein and RNA analysis results will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Exploratory categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.
Other	Citrate Intracellular Tricarboxylic Acid (TCA) Cycle Metabolite Concentrations	At radical prostatectomy	Citrate intracellular TCA cycle metabolite concentrations will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Exploratory categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.
Other	Pathological Response	Up to 4 weeks post-surgery	Pathological response will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Exploratory categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.
Other	Hyperpolarized 1-13C-pyruvate Imaging Results	Up to 4 weeks post-surgery	Hyperpolarized 1-13C-pyruvate imaging results will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Exploratory categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.

Source ClinicalTrials.gov

Outcomes10

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Number of Participants With Rate of Pathologic Stage =< pT2N0 at Prostatectomy	At the time of radical prostatectomy		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Incidence of Adverse Events	From screening up to 4 weeks post-surgery, an average of 7 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Tumor Epithelium Volume in the Surgical Specimen	At the time of radical prostatectomy	Tumor epithelium volume in the surgical specimen analysis is unavailable due to no data collected.
SECONDARY	Assessment of Positive Surgical Margins in the Surgical Specimen	At the time of radical prostatectomy	Assessment of positive surgical margins in the surgical specimen analysis is not available due to no data collected.
SECONDARY	Time to Prostate Specific Antigen Recurrence (TTRPSA)	From the date of randomization up to 4 weeks post-surgery	Time to prostate specific antigen recurrence (TTRPSA) analysis is not available due to no data collected.
OTHER_PRE_SPECIFIED	Assessment of Steroid Hormone Metabolome in Blood Plasma and Tissue	At radical prostatectomy
OTHER_PRE_SPECIFIED	Assessment of Protein and Ribonucleic Acid (RNA) Analysis Results	At radical prostatectomy
OTHER_PRE_SPECIFIED	Citrate Intracellular Tricarboxylic Acid (TCA) Cycle Metabolite Concentrations	At radical prostatectomy
OTHER_PRE_SPECIFIED	Pathological Response	Up to 4 weeks post-surgery
OTHER_PRE_SPECIFIED	Hyperpolarized 1-13C-pyruvate Imaging Results	Up to 4 weeks post-surgery

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Category	Value	Units
The Number of Participants With Rate of Pathologic Stage =< pT2N0 at Prostatectomy	Arm A (LHRHa, Apalutamide)		13	Participants
The Number of Participants With Rate of Pathologic Stage =< pT2N0 at Prostatectomy	Arm B (LHRHa, Apalutamide, Abiraterone Acetate)		12	Participants
Number of Participants With Incidence of Adverse Events	Arm A (LHRHa, Apalutamide)	Serious	1	Participants
Number of Participants With Incidence of Adverse Events	Arm B (LHRHa, Apalutamide, Abiraterone Acetate)	Serious	2	Participants
Number of Participants With Incidence of Adverse Events	Arm A (LHRHa, Apalutamide)	Non Serious	34	Participants
Number of Participants With Incidence of Adverse Events	Arm B (LHRHa, Apalutamide, Abiraterone Acetate)	Non Serious	34	Participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A (LHRHa, Apalutamide)	34
Overall Study	STARTED	Arm B (LHRHa, Apalutamide, Abiraterone Acetate)	34
Overall Study	COMPLETED	Arm A (LHRHa, Apalutamide)	34
Overall Study	COMPLETED	Arm B (LHRHa, Apalutamide, Abiraterone Acetate)	34
Overall Study	NOT COMPLETED	Arm A (LHRHa, Apalutamide)	0
Overall Study	NOT COMPLETED	Arm B (LHRHa, Apalutamide, Abiraterone Acetate)	0

Source ClinicalTrials.gov

Adverse events98

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	ALT increase	Investigations	Arm A (LHRHa, Apalutamide)	3	34	5
other	ALT increase	Investigations	Arm B (LHRHa, Apalutamide, Abiraterone Acetate)	8	34	14
other	Alopecia	Skin and subcutaneous tissue disorders	Arm A (LHRHa, Apalutamide)	3	34	3
other	Alopecia	Skin and subcutaneous tissue disorders	Arm B (LHRHa, Apalutamide, Abiraterone Acetate)	0	34	0
other	Anemia	Blood and lymphatic system disorders	Arm A (LHRHa, Apalutamide)	21	34	28
other	Anemia	Blood and lymphatic system disorders	Arm B (LHRHa, Apalutamide, Abiraterone Acetate)	15	34	19
other	Anorexia	Metabolism and nutrition disorders	Arm A (LHRHa, Apalutamide)	2	34	2
other	Anorexia	Metabolism and nutrition disorders	Arm B (LHRHa, Apalutamide, Abiraterone Acetate)	1	34	1
other	Anxiety	Psychiatric disorders	Arm A (LHRHa, Apalutamide)	4	34	4
other	Anxiety	Psychiatric disorders	Arm B (LHRHa, Apalutamide, Abiraterone Acetate)	1	34	1

1 to 10 of 98Source ClinicalTrials.gov

See all 98 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A (LHRHa, Apalutamide)	1	34
Total, all-cause mortality	Arm B (LHRHa, Apalutamide, Abiraterone Acetate)	1	34
Total, other adverse events	Arm A (LHRHa, Apalutamide)	34	34
Total, other adverse events	Arm B (LHRHa, Apalutamide, Abiraterone Acetate)	34	34
Total, serious adverse events	Arm A (LHRHa, Apalutamide)	1	34
Total, serious adverse events	Arm B (LHRHa, Apalutamide, Abiraterone Acetate)	2	34

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
41202201	DERIVED

Source PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA016672	The University of Texas MD Anderson Cancer Center Support Grant (CCSG)	KOONG, ALBERT	UNIVERSITY OF TX MD ANDERSON CAN CTR	NATIONAL CANCER INSTITUTE	1985 to 2026

Source NIH RePORTER

Trial comparisons3

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

Comparison	Source
Arm A (LHRHa, Apalutamide) vs Arm B (LHRHa, Apalutamide, Abiraterone Acetate): The Number of Participants With Rate of Pathologic Stage =< pT2N0 at Prostatectomy	Trial comparisons
Arm A (LHRHa, Apalutamide) vs Arm B (LHRHa, Apalutamide, Abiraterone Acetate): deaths from any cause	Trial comparisons
Arm A (LHRHa, Apalutamide) vs Arm B (LHRHa, Apalutamide, Abiraterone Acetate): 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.

For software

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/NCT03279250

GET https://conductscience.org/api/trials/v1/NCT03279250/events?page=2

API reference For AI assistants