The Number of Participants With Rate of Pathologic Stage =< pT2N0 at Prostatectomy
| Group | Value (Participants) |
|---|---|
| Arm A (LHRHa, Apalutamide) | 13 |
| Arm B (LHRHa, Apalutamide, Abiraterone Acetate) | 12 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataThis trial does not test a peptide that PepBank tracks.
United States
1 trial · 1 completed · 1 with posted results
Apalutamide and Gonadotropin-Releasing Hormone Analog With or Without Abiraterone Acetate in Treating Participants With Prostate Cancer
NCT0327925013 Oct 2017 to 11 May 2021
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This phase II trial studies how well apalutamide and gonadotropin-releasing hormone analog with or without abiraterone acetate work in treating participants with prostate cancer prior to surgery. Apalutamide and abiraterone acetate may stop the growth of cancer cells either by killing the cells or by blocking some of the enzymes needed for cell growth. Hormone therapy, using gonadotropin-releasing hormone analog, may fight prostate cancer by lowering the amount of testosterone the body makes. Giving apalutamide, gonadotropin-releasing hormone analog, and abiraterone acetate may work better in treating participants with prostate cancer.
Experimental
Arm A (LHRHa, apalutamide)
Participants receive gonadotropin-releasing hormone analog (leuprolide, goserelin, or triptorelin as determined by treating physician) IM once every 3 months and apalutamide PO QD. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning no less than 48 hours after completion of therapy, participants undergo radical prostatectomy.
Experimental
Arm B (LHRHa, apalutamide, abiraterone acetate)
Participants receive gonadotropin-releasing hormone analog and apalutamide as in arm A, abiraterone acetate PO QD, and prednisone PO QD. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning no less than 48 hours after completion of therapy, participants undergo radical prostatectomy.
Outcomes the sponsor listed as primary.
The Number of Participants With Rate of Pathologic Stage =< pT2N0 at Prostatectomy
Time frame · At the time of radical prostatectomy
The study will provide a point estimate and 95% confidence interval of the proportion of patients with pathologic stage =\< pT2N0 at prostatectomy for each arm. Patient characteristics will be summarized using descriptive statistics for each arm.
Number of Participants With Incidence of Adverse Events
Time frame · From screening up to 4 weeks post-surgery, an average of 7 months
Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Incidence of serious adverse events and 95% confidence interval will be provided overall as well as for each major affected organ category.
Tumor Epithelium Volume in the Surgical Specimen
Time frame · At the time of radical prostatectomy
Tumor volume will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Secondary categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.
Assessment of Positive Surgical Margins in the Surgical Specimen
Time frame · At the time of radical prostatectomy
Presence of positive surgical margins will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Secondary categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.
Time to Prostate Specific Antigen Recurrence (TTRPSA)
Time frame · From the date of randomization up to 4 weeks post-surgery
TTRPSA will be summarized by Kaplan-Meier estimates and confidence intervals. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Secondary categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| Arm A (LHRHa, Apalutamide) | 13 |
| Arm B (LHRHa, Apalutamide, Abiraterone Acetate) | 12 |
| Group | Value (Participants) |
|---|---|
| Arm A (LHRHa, Apalutamide) | 1 |
| Arm B (LHRHa, Apalutamide, Abiraterone Acetate) | 2 |
| Group | Value |
|---|---|
| Arm A (LHRHa, Apalutamide) | not posted |
| Arm B (LHRHa, Apalutamide, Abiraterone Acetate) | not posted |
| Group | Value |
|---|---|
| Arm A (LHRHa, Apalutamide) | not posted |
| Arm B (LHRHa, Apalutamide, Abiraterone Acetate) | not posted |
| Group | Value |
|---|---|
| Arm A (LHRHa, Apalutamide) | not posted |
| Arm B (LHRHa, Apalutamide, Abiraterone Acetate) | not posted |
| Group | Value |
|---|
| Group | Value |
|---|
| Group | Value |
|---|
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Arm A (LHRHa, Apalutamide)Participants receive gonadotropin-releasing hormone analog (leuprolide, goserelin, or triptorelin as determined by treating physician) IM once every 3 months and apalutamide PO QD. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning no less than 48 hours after completion of therapy, participants undergo radical prostatectomy. Apalutamide: Given PO Gonadotropin-releasing Hormone Analog: Given IM Radical Prostatectomy: Undergo radical prostatectomy | 1 / 34 | 1 / 34 | 34 / 34 |
| Arm B (LHRHa, Apalutamide, Abiraterone Acetate)Participants receive gonadotropin-releasing hormone analog and apalutamide as in arm A, abiraterone acetate PO QD, and prednisone PO QD. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning no less than 48 hours after completion of therapy, participants undergo radical prostatectomy. Abiraterone Acetate: Given PO Apalutamide: Given PO Gonadotropin-releasing Hormone Analog: Given IM Prednisone: Given PO Radical Prostatectomy: Undergo radical prostatectomy | 1 / 34 | 2 / 34 | 34 / 34 |
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