Proportion of Patients With =< 5% Tumor Involvement
| Group | Value |
|---|---|
| Group A-GDC-0449 and Androgen Ablation (LHRHa | not posted |
| Group B Androgen Ablation (LHRHa) Alone | not posted |
Trial · Interventional
TerminatedPhase 1/2Results postedRegistry dataThis trial was stopped early.
The registry gives no reason.
Results were posted for this trial.
United States
1 trial · 1 stopped early · 1 with posted results
Leuprolide Acetate or Goserelin Acetate With or Without Vismodegib Followed by Surgery in Treating Patients With Locally Advanced Prostate Cancer
NCT011630849 Jul 2010 to 1 Jun 2012
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This randomized phase I/II trial studies giving leuprolide acetate or goserelin acetate together with or without vismodegib followed by surgery to see how well they work in treating patients with prostate cancer that has spread from where it started to nearby tissue or lymph nodes. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate or goserelin acetate, may lessen the amount of androgens made by the body. Vismodegib may slow the growth of tumor cells. Giving antihormone therapy together with vismodegib may be an effective treatment for prostate cancer.
Experimental
Arm I (leuprolide acetate, goserelin acetate, vismodegib)
Patients receive LHRH analogue comprising leuprolide acetate IM or goserelin acetate SC on day 1 and vismodegib PO QD on days 1-28. Treatment repeats every 28 days for up to 16 weeks in the absence of disease progression or unacceptable toxicity.
Active comparator
Arm II (leuprolide acetate, goserelin acetate)
Patients receive LHRH analogue comprising leuprolide acetate or goserelin acetate as in Arm I. Treatment repeats every 28 days for up to 16 weeks in the absence of disease progression or unacceptable toxicity.
Outcomes the sponsor listed as primary.
Proportion of Patients With =< 5% Tumor Involvement
Time frame · 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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value |
|---|---|
| Group A-GDC-0449 and Androgen Ablation (LHRHa | not posted |
| Group B Androgen Ablation (LHRHa) Alone | not posted |
| Group | Value |
|---|
| Group | Value |
|---|
| Group | Value |
|---|
| Group | Value |
|---|
| Group | Value |
|---|
| Group | Value |
|---|
| Group | Value |
|---|
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Group A- GDC-0449 and Androgen Ablation (LHRHa)Group A will receive 150mg GDC-0449 daily for 3 months prior to radical prostatectomy. | 0 / 4 | 0 / 4 | 4 / 4 |
| Group B- Androgren Ablation (LHRHa) AlonePatients will receive an LHRHa (monthly injection or three-month injection) for a maximum of 4 months before a prostatectomy is performed. | 0 / 5 | 0 / 5 | 5 / 5 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
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References listed at the registry that are not in PepBank. They link to PubMed.
Who could join, as posted.
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