Trial · NCT01163084

Leuprolide Acetate or Goserelin Acetate With or Without Vismodegib Followed by Surgery in Treating Patients With Locally Advanced Prostate Cancer

NCT01163084, Phase 1, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2019-02-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Leuprolide Acetate or Goserelin Acetate With or Without Vismodegib Followed by Surgery in Treating Patients With Locally Advanced Prostate Cancer. Trials, record NCT01163084. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01163084

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Trial

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

Title: Leuprolide Acetate or Goserelin Acetate With or Without Vismodegib Followed by Surgery in Treating Patients With Locally Advanced Prostate Cancer
NCT number: NCT01163084
Status: Terminated
Phases: Phase 1, Phase 2
Enrollment: 10 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Prostate Adenocarcinoma, Stage IIA Prostate Cancer AJCC v7, Stage IIB Prostate Cancer AJCC v7
Interventions: Goserelin Acetate, Laboratory Biomarker Analysis, Leuprolide Acetate, Vismodegib
First posted: 2010-07-15
Last updated: 2019-02-28
Results first posted: 2019-02-28

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Proportion of Patients With =< 5% Tumor Involvement	Baseline up to 4 months or radical prostatectomy, whichever comes first	Each patient's pathologic staging will be assessed from the samples collected from prostatectomy. Will be descriptively summarized. Two-sided Chi-Square test will be used to provide the test of significance between the 2 groups of LHRHa versus LHRHa plus vismodegib.
Other	Differences in Relapse Rates by PSA Levels (Biochemical)	Date of surgery, then every 6 months, up to 8 years	Will be descriptively summarized.
Other	Time to PSA (Biochemical) Progression, Defined as PSA Recurrence	From the date of surgery and elevated post operative PSA concentration, assessed up to 8 years	Will be descriptively summarized. PSA recurrence is defined as two (2) serial measureable rises in PSA concentration above the undetectable level with the standard assay (\> 0.1 ng/mL).
Other	Time to PSA (Clinical) Progression, Defined as a Serial Rise in PSA Concentration in the Presence of Castrate Serum Testosterone Concentration or Radiographic Evidence of Progression	From the date of surgery and elevated post operative PSA concentration, assessed up to 8 years	Will be descriptively summarized. PSA recurrence is defined as two (2) serial measureable rises in PSA concentration above the undetectable level with the standard assay (\> 0.1 ng/mL).
Other	Proportion of Patients With PSA =< 0.2 ng/mL	Up to 8 years	Will be descriptively summarized.
Other	Differences in the Rate of Positive Surgical Margins Between the Two Groups	Baseline to up to 8 years	Will be descriptively summarized.
Other	Differences in Relapse Rates by Bone Scan/Computed Tomography Scan (Objective)	Baseline to up to 8 years	Will be descriptively summarized.
Other	Proportion of Patients Expressing Differences in Hedgehog, Androgen Signaling and Related Genes Markers	Up to 8 years

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Population
PRIMARY	Proportion of Patients With =< 5% Tumor Involvement	Baseline up to 4 months or radical prostatectomy, whichever comes first	Results was not determined.
OTHER_PRE_SPECIFIED	Differences in Relapse Rates by PSA Levels (Biochemical)	Date of surgery, then every 6 months, up to 8 years
OTHER_PRE_SPECIFIED	Time to PSA (Biochemical) Progression, Defined as PSA Recurrence	From the date of surgery and elevated post operative PSA concentration, assessed up to 8 years
OTHER_PRE_SPECIFIED	Time to PSA (Clinical) Progression, Defined as a Serial Rise in PSA Concentration in the Presence of Castrate Serum Testosterone Concentration or Radiographic Evidence of Progression	From the date of surgery and elevated post operative PSA concentration, assessed up to 8 years
OTHER_PRE_SPECIFIED	Proportion of Patients With PSA =< 0.2 ng/mL	Up to 8 years
OTHER_PRE_SPECIFIED	Differences in the Rate of Positive Surgical Margins Between the Two Groups	Baseline to up to 8 years
OTHER_PRE_SPECIFIED	Differences in Relapse Rates by Bone Scan/Computed Tomography Scan (Objective)	Baseline to up to 8 years
OTHER_PRE_SPECIFIED	Proportion of Patients Expressing Differences in Hedgehog, Androgen Signaling and Related Genes Markers	Up to 8 years

Source ClinicalTrials.gov

Results by group0

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

None in this release.

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Group A- GDC-0449 and Androgen Ablation (LHRHa)	4
Overall Study	STARTED	Group B- Androgren Ablation (LHRHa) Alone	5
Overall Study	COMPLETED	Group A- GDC-0449 and Androgen Ablation (LHRHa)	4
Overall Study	COMPLETED	Group B- Androgren Ablation (LHRHa) Alone	5
Overall Study	NOT COMPLETED	Group A- GDC-0449 and Androgen Ablation (LHRHa)	0
Overall Study	NOT COMPLETED	Group B- Androgren Ablation (LHRHa) Alone	0

Source ClinicalTrials.gov

Adverse events54

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
other	Allergic Rhinitis	Respiratory, thoracic and mediastinal disorders	Group A- GDC-0449 and Androgen Ablation (LHRHa)	1	4
other	Allergic Rhinitis	Respiratory, thoracic and mediastinal disorders	Group B- Androgren Ablation (LHRHa) Alone	0	5
other	Anemia	Blood and lymphatic system disorders	Group A- GDC-0449 and Androgen Ablation (LHRHa)	1	4
other	Anemia	Blood and lymphatic system disorders	Group B- Androgren Ablation (LHRHa) Alone	3	5
other	Back Pain	Musculoskeletal and connective tissue disorders	Group A- GDC-0449 and Androgen Ablation (LHRHa)	0	4
other	Back Pain	Musculoskeletal and connective tissue disorders	Group B- Androgren Ablation (LHRHa) Alone	1	5
other	Cholesterol, high	Investigations	Group A- GDC-0449 and Androgen Ablation (LHRHa)	2	4
other	Cholesterol, high	Investigations	Group B- Androgren Ablation (LHRHa) Alone	1	5
other	Constipation	Gastrointestinal disorders	Group A- GDC-0449 and Androgen Ablation (LHRHa)	1	4
other	Constipation	Gastrointestinal disorders	Group B- Androgren Ablation (LHRHa) Alone	0	5

1 to 10 of 54Source ClinicalTrials.gov

See all 54 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Group A- GDC-0449 and Androgen Ablation (LHRHa)	0	4
Total, all-cause mortality	Group B- Androgren Ablation (LHRHa) Alone	0	5
Total, other adverse events	Group A- GDC-0449 and Androgen Ablation (LHRHa)	4	4
Total, other adverse events	Group B- Androgren Ablation (LHRHa) Alone	5	5
Total, serious adverse events	Group A- GDC-0449 and Androgen Ablation (LHRHa)	0	4
Total, serious adverse events	Group B- Androgren Ablation (LHRHa) Alone	0	5

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20818327	DERIVED

Source PubMed

Grants3

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	Source
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	NIH RePORTER
U01CA062461	Phase I Studies of Targeted Anti-Cancer Therapies	YAO, JAMES C	UNIVERSITY OF TX MD ANDERSON CAN CTR	NATIONAL CANCER INSTITUTE	1994 to 2013	NIH RePORTER
U01CA062491	Early Clinical Trials of New Anti-Cancer Agents with Phase 1 Emphasis (U01)	LIU, GLENN	UNIVERSITY OF WISCONSIN-MADISON	NATIONAL CANCER INSTITUTE	1994 to 2013	NIH RePORTER

Trial comparisons2

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

Comparison	Source
Group A- GDC-0449 and Androgen Ablation (LHRHa) vs Group B- Androgren Ablation (LHRHa) Alone: deaths from any cause	Trial comparisons
Group A- GDC-0449 and Androgen Ablation (LHRHa) vs Group B- Androgren Ablation (LHRHa) Alone: 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/NCT01163084

GET https://conductscience.org/api/trials/v1/NCT01163084/events?page=2

API reference For AI assistants