Median Time to PSA Progression
| Group | Value |
|---|---|
| Pazopanib, Leuprolide Acetate, and Goserelin Acetate | not posted |
| Leuprolide Acetate and Goserelin Acetate Only | not posted |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Pazopanib Hydrochloride After Leuprolide Acetate or Goserelin Acetate in Treating Patients With Relapsed Prostate Cancer
NCT00454571Jun 2006 to Dec 2010
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This randomized phase II trial is studying how well pazopanib hydrochloride works after leuprolide or goserelin in treating patients with relapsed prostate cancer. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. 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. Giving pazopanib after leuprolide or goserelin may be an effective treatment for prostate cancer
Experimental
Pazopanib
Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Active comparator
Observation
Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.
Outcomes the sponsor listed as primary.
Median Time to PSA Progression
Time frame · Baseline, every 4 weeks during treatment, and up to 12 months after completion of study treatment
The median time to disease progression for the therapy and observation groups will be estimated using the Kaplan-Meier estimate and compared using the log-rank test.
Median PSA Progression-free Survival
Time frame · Time from randomization to PSA progression or death from any cause
Kaplan-Meier estimates for PSA progression-free survival will be computed for the pazopanib and active surveillance groups and compared using the log rank test. The outcome measure is median PSA progression-free survival time.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value |
|---|---|
| Pazopanib, Leuprolide Acetate, and Goserelin Acetate | not posted |
| Leuprolide Acetate and Goserelin Acetate Only | not posted |
| Group | Value |
|---|---|
| Pazopanib, Leuprolide Acetate, and Goserelin Acetate | not posted |
| Leuprolide Acetate and Goserelin Acetate Only | not posted |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Pazopanib, Leuprolide Acetate, and Goserelin AcetatePatients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. pazopanib hydrochloride: Given PO leuprolide acetate goserelin acetate | – | 5 / 18 | 16 / 18 |
| Leuprolide Acetate and Goserelin Acetate OnlyPatients undergo observation after treatment with leuprolide acetate and goserelin acetate. leuprolide acetate goserelin acetate | – | 0 / 19 | 2 / 19 |
Each cell reads participants affected / participants at risk, as the registry posted them.
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Studies that cite this trial.
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