Percentage of Participants With Pathologic Complete Response (pCR) or Minimal Residual Disease (MRD)
| Group | Value (percentage of participants) |
|---|---|
| ARM 1 | 30 |
| ARM 2 | 16 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study is comparing the effectiveness of enzalutamide with or without abiraterone acetate for men with high-risk, localized prostate cancer.
Experimental
ARM 1
Participants will be randomized in a 2:1 ratio to neoadjuvant treatment (ARM 1) or (ARM 2). Participants will receive the assigned study treatment per cycle * Enzalutamide- Once daily at prespecified dose, orally * Abiraterone Acetate- Once daily at prespecified dose, orally * Prednisone-Once daily at prespecified dose, orally * Leuprolide Acetate-Intermuscular injection at prespecified dose and duration
Experimental
ARM 2
Participants will be randomized in a 2:1 ratio to neoadjuvant treatment (ARM 1) or (ARM 2). Participants will receive the assigned study treatment per cycle. * Enzalutamide- once daily at prespecified dose, orally * Leuprolide Acetate- Intermuscular injection at prespecified dose and duration
Outcomes the sponsor listed as primary.
Percentage of Participants With Pathologic Complete Response (pCR) or Minimal Residual Disease (MRD)
Time frame · after RP approximately 24 weeks from study entry
pCR is defined as the absence of morphologically identifiable carcinoma in the radical prostatectomy (RP) specimen. MRD is defined as the largest cross-sectional dimension of residual tumor measuring \</= 0.5 cm. If the tumor is multifocal, the size of the largest focus will be used to determine the size of the residual tumor.
Participants With Pathologic Complete Response (pCR)
Time frame · after RP approximately 24 weeks from study entry
pCR is defined as the absence of morphologically identifiable carcinoma in the radical prostatectomy (RP) specimen.
Residual Cancer Burden (RCB)
Time frame · after RP approximately 24 weeks from study entry
RCB was analyzed using radical prostatectomy (RP) tissue. The largest area of tumor was measured by ruler and the longest tumor dimension in this area was used as the dimension for calculation.
Positive Surgical Margin Status
Time frame · after RP approximately 24 weeks from study entry
Participants were classified by presence or absence of positive surgical margins defined as margins, which are the edges of the removed tumor, that show some cancer cells.
Median Prostate Specific Antigen (PSA) Nadir
Time frame · PSA was assessed at baseline and every cycle during neoadjuvant therapy (up to 24 weeks).
PSA nadir is the lowest PSA level recorded during neoadjuvant therapy.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of participants) |
|---|---|
| ARM 1 | 30 |
| ARM 2 | 16 |
| Group | Value (Participants) |
|---|---|
| ARM 1 | 5 |
| ARM 2 | 2 |
| Group | Value (cm) |
|---|---|
| ARM 1 | 0.03 |
| ARM 2 | 0.05 |
| Group | Value (Participants) |
|---|---|
| ARM 1 | 41 |
| ARM 2 | 22 |
| Group | Value (ng/mL) |
|---|---|
| ARM 1 | 0.03 |
| ARM 2 | 0.02 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| ARM 1Enzalutamide: 160 mg (four 40 mg capsules), oral, once daily, 28 days (4 weeks) 6 cycles maximum. Abiraterone Acetate: 1000 mg (four 250 mg tablets), oral, once daily, 28 days (4 weeks) 6 cycles maximum. Prednisone: 5 mg, oral, once daily, 28 days (4 weeks) 6 cycles maximum. Leuprolide Acetate: Either 7.5 mg monthly or 22.5 mg every three months, Intramuscular, monthly or every three months. | 0 / 50 | 3 / 50 | 50 / 50 |
| ARM 2Enzalutamide: 160 mg (four 40 mg capsules), oral, once daily, 28 days (4 weeks) 6 cycles maximum. Leuprolide Acetate: Either 7.5 mg monthly or 22.5 mg every three months, Intramuscular, monthly or every three months. | 0 / 25 | 1 / 25 | 25 / 25 |
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.
1 study on this page
Indexing hint: Randomized controlled trial · 2019
McKay et al. 2019Journal of clinical oncology : official journal of the American Society of Clinical Oncologycited by 114
PMID 30811282PMC7051849DOI 10.1200/jco.18.01777PUB-30811282
References listed at the registry that are not in PepBank. They link to PubMed.
Who could join, as posted.
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