Trial Outcomes & Findings for Leuprolide Acetate or Goserelin Acetate With or Without Vismodegib Followed by Surgery in Treating Patients With Locally Advanced Prostate Cancer (NCT NCT01163084)

Last Updated: 2019-02-28

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Baseline up to 4 months or radical prostatectomy, whichever comes first

Results posted on

2019-02-28

Participant Flow

Participants were recruited by physicians in the Genitourinary Medical Oncology Clinic and Urology clinic.

10 participants started but only 9 were randomized

Participant milestones

Participant milestones
Measure	Group A- GDC-0449 and Androgen Ablation (LHRHa) Group A will receive 150mg GDC-0449 daily for 3 months prior to radical prostatectomy.	Group B- Androgren Ablation (LHRHa) Alone Patients will receive an LHRHa (monthly injection or three-month injection) for a maximum of 4 months before a prostatectomy is performed.
Overall Study STARTED	4	5
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A- GDC-0449 and Androgen Ablation (LHRHa) n=4 Participants Group A will receive 150mg GDC-0449 daily for 3 months prior to radical prostatectomy.	Group- B Androgren Ablation (LHRHa) Alone n=5 Participants Patients will receive an LHRHa (monthly injection or three-month injection) for a maximum of 4 months before a prostatectomy is performed.	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Continuous	63 years n=5 Participants	63 years n=7 Participants	63 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 4 months or radical prostatectomy, whichever comes first

Population: Results was not determined.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Date of surgery, then every 6 months, up to 8 years

Will be descriptively summarized.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 8 years

Will be descriptively summarized.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to up to 8 years

Will be descriptively summarized.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to up to 8 years

Will be descriptively summarized.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 8 years

Outcome measures

Outcome data not reported

Adverse Events

Group A- GDC-0449 and Androgen Ablation (LHRHa)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Group B- Androgren Ablation (LHRHa) Alone

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Logothetis, Christopher, M.D. / Genitourinary Medical Oncology

UT MD Anderson Cancer Center

Phone: 7137922830

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Group A- GDC-0449 and Androgen Ablation (LHRHa) n=4 participants at risk Group A will receive 150mg GDC-0449 daily for 3 months prior to radical prostatectomy.	Group B- Androgren Ablation (LHRHa) Alone n=5 participants at risk Patients will receive an LHRHa (monthly injection or three-month injection) for a maximum of 4 months before a prostatectomy is performed.
Respiratory, thoracic and mediastinal disorders Allergic Rhinitis	25.0% 1/4 • 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. All adverse events reported as routine part of a clinical trial.	0.00% 0/5 • 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. All adverse events reported as routine part of a clinical trial.
Blood and lymphatic system disorders Anemia	25.0% 1/4 • 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. All adverse events reported as routine part of a clinical trial.	60.0% 3/5 • 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. All adverse events reported as routine part of a clinical trial.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/4 • 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. All adverse events reported as routine part of a clinical trial.	20.0% 1/5 • 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. All adverse events reported as routine part of a clinical trial.
Investigations Cholesterol, high	50.0% 2/4 • 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. All adverse events reported as routine part of a clinical trial.	20.0% 1/5 • 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. All adverse events reported as routine part of a clinical trial.
Gastrointestinal disorders Constipation	25.0% 1/4 • 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. All adverse events reported as routine part of a clinical trial.	0.00% 0/5 • 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. All adverse events reported as routine part of a clinical trial.
Psychiatric disorders Depression	0.00% 0/4 • 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. All adverse events reported as routine part of a clinical trial.	20.0% 1/5 • 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. All adverse events reported as routine part of a clinical trial.
Nervous system disorders Dysgeusia	50.0% 2/4 • 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. All adverse events reported as routine part of a clinical trial.	0.00% 0/5 • 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. All adverse events reported as routine part of a clinical trial.
Blood and lymphatic system disorders Edema Limbs	0.00% 0/4 • 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. All adverse events reported as routine part of a clinical trial.	20.0% 1/5 • 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. All adverse events reported as routine part of a clinical trial.
General disorders Fatigue	100.0% 4/4 • 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. All adverse events reported as routine part of a clinical trial.	40.0% 2/5 • 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. All adverse events reported as routine part of a clinical trial.
Nervous system disorders Headache	25.0% 1/4 • 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. All adverse events reported as routine part of a clinical trial.	0.00% 0/5 • 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. All adverse events reported as routine part of a clinical trial.
Vascular disorders Hot flashes	50.0% 2/4 • 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. All adverse events reported as routine part of a clinical trial.	80.0% 4/5 • 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. All adverse events reported as routine part of a clinical trial.
Metabolism and nutrition disorders Hyperglycemia	25.0% 1/4 • 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. All adverse events reported as routine part of a clinical trial.	20.0% 1/5 • 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. All adverse events reported as routine part of a clinical trial.
Vascular disorders Hypertension	25.0% 1/4 • 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. All adverse events reported as routine part of a clinical trial.	0.00% 0/5 • 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. All adverse events reported as routine part of a clinical trial.
Metabolism and nutrition disorders Hyperuricemia	25.0% 1/4 • 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. All adverse events reported as routine part of a clinical trial.	20.0% 1/5 • 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. All adverse events reported as routine part of a clinical trial.
Metabolism and nutrition disorders Hypokalemia	50.0% 2/4 • 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. All adverse events reported as routine part of a clinical trial.	0.00% 0/5 • 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. All adverse events reported as routine part of a clinical trial.
Metabolism and nutrition disorders Hypophosphatemia	25.0% 1/4 • 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. All adverse events reported as routine part of a clinical trial.	80.0% 4/5 • 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. All adverse events reported as routine part of a clinical trial.
Vascular disorders hypotension	25.0% 1/4 • 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. All adverse events reported as routine part of a clinical trial.	0.00% 0/5 • 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. All adverse events reported as routine part of a clinical trial.
Musculoskeletal and connective tissue disorders Myalgia	75.0% 3/4 • 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. All adverse events reported as routine part of a clinical trial.	0.00% 0/5 • 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. All adverse events reported as routine part of a clinical trial.
General disorders Pain	0.00% 0/4 • 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. All adverse events reported as routine part of a clinical trial.	20.0% 1/5 • 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. All adverse events reported as routine part of a clinical trial.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • 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. All adverse events reported as routine part of a clinical trial.	20.0% 1/5 • 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. All adverse events reported as routine part of a clinical trial.
Renal and urinary disorders Proteinuria	25.0% 1/4 • 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. All adverse events reported as routine part of a clinical trial.	0.00% 0/5 • 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. All adverse events reported as routine part of a clinical trial.
Skin and subcutaneous tissue disorders Rash acneiform	25.0% 1/4 • 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. All adverse events reported as routine part of a clinical trial.	0.00% 0/5 • 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. All adverse events reported as routine part of a clinical trial.
Skin and subcutaneous tissue disorders Rash pustular	0.00% 0/4 • 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. All adverse events reported as routine part of a clinical trial.	20.0% 1/5 • 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. All adverse events reported as routine part of a clinical trial.
Nervous system disorders Spasticity	25.0% 1/4 • 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. All adverse events reported as routine part of a clinical trial.	0.00% 0/5 • 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. All adverse events reported as routine part of a clinical trial.
Renal and urinary disorders Urinal frequency	0.00% 0/4 • 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. All adverse events reported as routine part of a clinical trial.	20.0% 1/5 • 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. All adverse events reported as routine part of a clinical trial.
Eye disorders Watering eyes	25.0% 1/4 • 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. All adverse events reported as routine part of a clinical trial.	0.00% 0/5 • 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. All adverse events reported as routine part of a clinical trial.
Skin and subcutaneous tissue disorders Dry Skin	25.0% 1/4 • 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. All adverse events reported as routine part of a clinical trial.	0.00% 0/5 • 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. All adverse events reported as routine part of a clinical trial.