Undetectable PSA Rate
| Group | Value (participants) |
|---|---|
| Arm I (Androgen Deprivation and Cixutumumab) | 42 |
| Arm II (Androgen Deprivation Therapy) | 34 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States, Canada
1 trial · 1 completed · 1 with posted results
Bicalutamide and Goserelin or Leuprolide Acetate With or Without Cixutumumab in Treating Patients With Newly Diagnosed Metastatic Prostate Cancer
NCT01120236Dec 2010 to 23 Aug 2017
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This randomized phase II trial is studying bicalutamide, goserelin, or leuprolide acetate to see how well they work when given with or without cixutumumab in treating patients with newly diagnosed metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, goserelin, or leuprolide acetate, may lessen the amount of androgens made by the body. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether bicalutamide, goserelin, or leuprolide acetate are more effective when given with or without cixutumumab in treating prostate cancer.
Experimental
Arm I (androgen deprivation and cixutumumab)
Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Active comparator
Arm II (androgen deprivation therapy)
Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.
Outcomes the sponsor listed as primary.
Undetectable PSA Rate
Time frame · 7 months
Undetectable PSA rate (\<= 0.2 ng/mL) after seven cycles (28 weeks) of protocol treatment
Toxicity
Time frame · Up to 28 weeks
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Proportion of Patients Who do Not Achieve a Partial PSA Response
Time frame · Up to 5 years
A partial PSA response is considered \<= 4 ng/mL
Accuracy of the Prognostic Model of Undetectable PSA (Developed From SWOG-9346)
Time frame · Up to 5 years
The logistic regression algorithm for predicting undetectable PSA that was developed for SWOG-9346 using its baseline risk factors (age at registration, performance status, baseline PSA, and bone pain) will be applied to each arm of this trial to evaluate the level of agreement between the observed and predicted undetectable PSA rates.
Correlation of microRNA Measures With 28-week PSA Response
Time frame · Baseline to 28 weeks
The Friedman test will be used to evaluate correlations between microRNA measures (CT) and 28-week PSA response.
Correlation of microRNA Measures With Baseline Circulating Tumor Cell (CTC) Counts
Time frame · Baseline
The Friedman test will be used to evaluate correlations between microRNA measures (CT) and Baseline CTCs.
Change in Level of CTCs
Time frame · Baseline to 28 weeks
Will be correlated with 28-week PSA response.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (participants) |
|---|---|
| Arm I (Androgen Deprivation and Cixutumumab) | 42 |
| Arm II (Androgen Deprivation Therapy) | 34 |
| Group | Value (Participants) |
|---|---|
| Arm I (Androgen Deprivation and Cixutumumab) | 1 |
| Arm II (Androgen Deprivation Therapy) | 0 |
| Group | Value (participants) |
|---|---|
| Arm I (Androgen Deprivation and Cixutumumab) | 46 |
| Arm II (Androgen Deprivation Therapy) | 56 |
| Group | Value |
|---|---|
| Arm I (Androgen Deprivation and Cixutumumab) | not posted |
| Arm II (Androgen Deprivation Therapy) | not posted |
| Group | Value (Cycle Threshold (CT)) |
|---|---|
| PSA Complete Response | 32.6 |
| PSA Partial Response | 32.0 |
| PSA Non-Responders | 31.5 |
| Group | Value (Cycle Threshold (CT)) |
|---|---|
| CTC=0 | 33.0 |
| CTC= 1-4 | 32.7 |
| CTC= 5+ | 31.9 |
| Group | Value (Participants) |
|---|---|
| CTC=0 | 12 |
| CTC= 1-4 | 5 |
| CTC= 5+ | 4 |
| Group | Value (ng/mL) | Spread |
|---|---|---|
| Arm I (Androgen Deprivation and Cixutumumab) | -7 | 24.5 |
| Arm II (Androgen Deprivation Therapy) | 3 | 20.1 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Arm I (Androgen Deprivation and Cixutumumab)Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity. Bicalutamide: Given PO Cixutumumab: Given IV Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given IM Pharmacological Study: Correlative studies | – | 10 / 101 | 101 / 101 |
| Arm II (Androgen Deprivation Therapy)Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I. Bicalutamide: Given PO Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given IM Pharmacological Study: Correlative studies | – | 4 / 104 | 94 / 104 |
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