Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 50 of 78 for:    vismodegib

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01163084
Recruitment Status : Terminated
First Posted : July 15, 2010
Results First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Prostate Adenocarcinoma
Stage IIA Prostate Cancer AJCC v7
Stage IIB Prostate Cancer AJCC v7
Interventions Drug: Goserelin Acetate
Other: Laboratory Biomarker Analysis
Drug: Leuprolide Acetate
Drug: Vismodegib
Enrollment 10
Recruitment Details Participants were recruited by physicians in the Genitourinary Medical Oncology Clinic and Urology clinic.
Pre-assignment Details 10 participants started but only 9 were randomized
Arm/Group Title Group A- GDC-0449 and Androgen Ablation (LHRHa) Group B- Androgren Ablation (LHRHa) Alone
Hide Arm/Group Description Group A will receive 150mg GDC-0449 daily for 3 months prior to radical prostatectomy. Patients will receive an LHRHa (monthly injection or three-month injection) for a maximum of 4 months before a prostatectomy is performed.
Period Title: Overall Study
Started 4 5
Completed 4 5
Not Completed 0 0
Arm/Group Title Group A- GDC-0449 and Androgen Ablation (LHRHa) Group- B Androgren Ablation (LHRHa) Alone Total
Hide Arm/Group Description Group A will receive 150mg GDC-0449 daily for 3 months prior to radical prostatectomy. Patients will receive an LHRHa (monthly injection or three-month injection) for a maximum of 4 months before a prostatectomy is performed. Total of all reporting groups
Overall Number of Baseline Participants 4 5 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
<=18 years 0 0 0
Between 18 and 65 years 2 4 6
>=65 years 2 1 3
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants 5 participants 9 participants
63
(55 to 72)
63
(62 to 66)
63
(55 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
Female 0 0 0
Male 4 5 9
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
Hispanic or Latino 0 1 1
Not Hispanic or Latino 3 1 4
Unknown or Not Reported 1 3 4
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
American Indian or Alaska Native 0 0 0
Asian 0 0 0
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 0 0 0
White 3 4 7
More than one race 0 0 0
Unknown or Not Reported 1 1 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 5 participants 9 participants
4 5 9
1.Primary Outcome
Title Proportion of Patients With =< 5% Tumor Involvement
Hide Description 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.
Time Frame Baseline up to 4 months or radical prostatectomy, whichever comes first
Hide Outcome Measure Data
Hide Analysis Population Description
Results was not determined.
Arm/Group Title Group A-GDC-0449 and Androgen Ablation (LHRHa Group B Androgen Ablation (LHRHa) Alone
Hide Arm/Group Description:
Group A will receive 150mg GDC-0449 daily for 3 months prior to radical prostatectomy
Patients will receive an LHRHa (monthly injection or three-month injection) for a maximum of 4 months before a prostatectomy is performed.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Other Pre-specified Outcome
Title Differences in Relapse Rates by PSA Levels (Biochemical)
Hide Description Will be descriptively summarized.
Time Frame Date of surgery, then every 6 months, up to 8 years
Outcome Measure Data Not Reported
3.Other Pre-specified Outcome
Title Time to PSA (Biochemical) Progression, Defined as PSA Recurrence
Hide Description 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).
Time Frame From the date of surgery and elevated post operative PSA concentration, assessed up to 8 years
Outcome Measure Data Not Reported
4.Other Pre-specified Outcome
Title 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
Hide Description 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).
Time Frame From the date of surgery and elevated post operative PSA concentration, assessed up to 8 years
Outcome Measure Data Not Reported
5.Other Pre-specified Outcome
Title Proportion of Patients With PSA =< 0.2 ng/mL
Hide Description Will be descriptively summarized.
Time Frame Up to 8 years
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title Differences in the Rate of Positive Surgical Margins Between the Two Groups
Hide Description Will be descriptively summarized.
Time Frame Baseline to up to 8 years
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Differences in Relapse Rates by Bone Scan/Computed Tomography Scan (Objective)
Hide Description Will be descriptively summarized.
Time Frame Baseline to up to 8 years
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Proportion of Patients Expressing Differences in Hedgehog, Androgen Signaling and Related Genes Markers
Hide Description [Not Specified]
Time Frame Up to 8 years
Outcome Measure Data Not Reported
Time Frame During on-study tests/visits that occur every 4 weeks for all participants until the follow up visit after radical prostatectomy, assessed up to 5 months.
Adverse Event Reporting Description All adverse events reported as routine part of a clinical trial.
 
Arm/Group Title Group A- GDC-0449 and Androgen Ablation (LHRHa) Group B- Androgren Ablation (LHRHa) Alone
Hide Arm/Group Description Group A will receive 150mg GDC-0449 daily for 3 months prior to radical prostatectomy. Patients will receive an LHRHa (monthly injection or three-month injection) for a maximum of 4 months before a prostatectomy is performed.
All-Cause Mortality
Group A- GDC-0449 and Androgen Ablation (LHRHa) Group B- Androgren Ablation (LHRHa) Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/5 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Group A- GDC-0449 and Androgen Ablation (LHRHa) Group B- Androgren Ablation (LHRHa) Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A- GDC-0449 and Androgen Ablation (LHRHa) Group B- Androgren Ablation (LHRHa) Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   4/4 (100.00%)   5/5 (100.00%) 
Blood and lymphatic system disorders     
Anemia  1  1/4 (25.00%)  3/5 (60.00%) 
Edema Limbs  1  0/4 (0.00%)  1/5 (20.00%) 
Eye disorders     
Watering eyes  1  1/4 (25.00%)  0/5 (0.00%) 
Gastrointestinal disorders     
Constipation  1  1/4 (25.00%)  0/5 (0.00%) 
General disorders     
Fatigue  1  4/4 (100.00%)  2/5 (40.00%) 
Pain  1  0/4 (0.00%)  1/5 (20.00%) 
Investigations     
Cholesterol, high  1  2/4 (50.00%)  1/5 (20.00%) 
Metabolism and nutrition disorders     
Hyperglycemia  1  1/4 (25.00%)  1/5 (20.00%) 
Hyperuricemia  1  1/4 (25.00%)  1/5 (20.00%) 
Hypokalemia  1  2/4 (50.00%)  0/5 (0.00%) 
Hypophosphatemia  1  1/4 (25.00%)  4/5 (80.00%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  0/4 (0.00%)  1/5 (20.00%) 
Myalgia  1  3/4 (75.00%)  0/5 (0.00%) 
Pain in extremity  1  0/4 (0.00%)  1/5 (20.00%) 
Nervous system disorders     
Dysgeusia  1  2/4 (50.00%)  0/5 (0.00%) 
Headache  1  1/4 (25.00%)  0/5 (0.00%) 
Spasticity  1  1/4 (25.00%)  0/5 (0.00%) 
Psychiatric disorders     
Depression  1  0/4 (0.00%)  1/5 (20.00%) 
Renal and urinary disorders     
Proteinuria  1  1/4 (25.00%)  0/5 (0.00%) 
Urinal frequency  1  0/4 (0.00%)  1/5 (20.00%) 
Respiratory, thoracic and mediastinal disorders     
Allergic Rhinitis  1  1/4 (25.00%)  0/5 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash acneiform  1  1/4 (25.00%)  0/5 (0.00%) 
Rash pustular  1  0/4 (0.00%)  1/5 (20.00%) 
Dry Skin  1  1/4 (25.00%)  0/5 (0.00%) 
Vascular disorders     
Hot flashes  1  2/4 (50.00%)  4/5 (80.00%) 
Hypertension  1  1/4 (25.00%)  0/5 (0.00%) 
hypotension  1  1/4 (25.00%)  0/5 (0.00%) 
1
Term from vocabulary, CTCAE 4.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Logothetis, Christopher, M.D. / Genitourinary Medical Oncology
Organization: UT MD Anderson Cancer Center
Phone: 7137922830
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01163084     History of Changes
Other Study ID Numbers: NCI-2010-01737
NCI-2010-01737 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000670590
2009-0473 ( Other Identifier: M D Anderson Cancer Center )
8384 ( Other Identifier: CTEP )
N01CM00039 ( U.S. NIH Grant/Contract )
N01CM62202 ( U.S. NIH Grant/Contract )
P30CA016672 ( U.S. NIH Grant/Contract )
U01CA062461 ( U.S. NIH Grant/Contract )
U01CA062491 ( U.S. NIH Grant/Contract )
First Submitted: July 14, 2010
First Posted: July 15, 2010
Results First Submitted: September 10, 2018
Results First Posted: February 28, 2019
Last Update Posted: February 28, 2019