Pathologic Complete Response Rate as Assessed From Prostatectomy Specimens Following Neoadjuvant Treatment
| Group | Value (Participants) |
|---|---|
| Treatment (Neoadjuvant Chemotherapy) | 1 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
A Phase II Neoadjuvant Study of Apalutamide, Abiraterone Acetate, Prednisone, Degarelix and Indomethacin in Men With Localized Prostate Cancer Pre-prostatectomy
NCT028499909 Mar 2017 to 10 Dec 2020
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This phase II trial studies how well apalutamide, abiraterone acetate, prednisone, degarelix, and indomethacin work in treating patients with prostate cancer that has spread from where it started to nearby tissue or lymph nodes before surgery. Androgen can cause the growth of tumor cells. Hormone therapy using apalutamide, abiraterone acetate, prednisone, degarelix, and indomethacin may fight prostate cancer by lowering the amount of androgen the body makes and/or blocking the use of androgen by the tumor cells.
Experimental
Treatment (neoadjuvant chemotherapy)
Patients receive androgen receptor antagonist ARN-509 and abiraterone acetate PO daily, prednisone PO BID and indomethacin PO TID. Patients also receive degarelix SC on day 1 and every 4 weeks for 3 doses. Treatment continues for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo prostatectomy on day 85.
Outcomes the sponsor listed as primary.
Pathologic Complete Response Rate as Assessed From Prostatectomy Specimens Following Neoadjuvant Treatment
Time frame · At 3 months
Pathologic complete response is defined as no evidence of cancer on fully submitted prostatectomy specimens using standard surgical pathology assessments (i.e. H\&E assessment will be used for the purpose of defining pathologic complete response per protocol) at 3 months.
Apoptotic Index (i.e. Percentage of Tumor Cells Undergoing Apoptosis)
Time frame · At 3 months
Will be determined by cleaved caspase-3 immunohistochemistry.
Number of Patients With a Negative Margin After 3 Months of Treatment
Time frame · At 3 months
The absence of tumor cells at the prostate margin will be assessed using standard pathological practices on prostatectomy specimens (i.e. after 3 months of treatment).
Overall Survival (OS)
Time frame · At 2 years
Will will report the number of participants alive at 2-years following enrollment.
Number of Patients With a Near Pathologic Complete Response After 3 Months of Treatment
Time frame · At 3 months
The near pathologic complete response will be defined as =\< 5 mm of residual tumor as assessed on prostatectomy specimens after 3 months of treatment.
Number of Patients With no Nodal Metastases After 3 Months of Treatment.
Time frame · At 3 months
The presence of tumor cells within surgically excised lymph nodes will be assessed after 3 months of treament.
Number of Patients With Pathologic T3 Disease After 3 Months of Treatment.
Time frame · At 3 months
The presence of T3 disease (e.g. extraprostatic tumor not invading adjacent structures) will be determine from the prostatectomy specimen after 3 months of treament.
Number of Participants Without Biochemical Failure at 2 Years
Time frame · At 2 years
Prostate-specific antigen progression (i.e. biochemical failure) will be defined per the American Urological Association guidelines (i.e. confirmed prostate-specific antigen post-radical prostatectomy \>= 0.2 ng/mL). We will report the number of patients without biochemical failure at 2 years.
The Proportion of Men Who Receive Adjuvant Radiation Therapy
Time frame · Up to 1 year post prostatectomy
Patients that received radiation following prostatetomy
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| Treatment (Neoadjuvant Chemotherapy) | 1 |
| Group | Value |
|---|---|
| Treatment (Neoadjuvant Chemotherapy) | not posted |
| Group | Value (Participants) |
|---|---|
| Treatment (Neoadjuvant Chemotherapy) | 13 |
| Group | Value (Participants) |
|---|---|
| Treatment (Neoadjuvant Chemotherapy) | 20 |
| Group | Value (Participants) |
|---|---|
| Treatment (Neoadjuvant Chemotherapy) | 6 |
| Group | Value (Participants) |
|---|---|
| Treatment (Neoadjuvant Chemotherapy) | 13 |
| Group | Value (Participants) |
|---|---|
| Treatment (Neoadjuvant Chemotherapy) | 18 |
| Group | Value (participants) |
|---|---|
| Treatment (Neoadjuvant Chemotherapy) | 18 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Treatment (Neoadjuvant Chemotherapy)Patients receive androgen receptor antagonist ARN-509 and abiraterone acetate PO daily, prednisone PO BID and indomethacin PO TID. Patients also receive degarelix SC on day 1 and every 4 weeks for 3 doses. Treatment continues for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo prostatectomy on day 85. Abiraterone Acetate: Given PO Apalutamide: Given PO Degarelix: Given SC Indomethacin: Given PO Laboratory Biomarker Analysis: Correlative study Prednisone: Given PO | 0 / 22 | 0 / 22 | 22 / 22 |
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