Trial Outcomes & Findings for Apalutamide in Treating Patients With Prostate Cancer Before Radical Prostatectomy (NCT NCT03412396)
NCT ID: NCT03412396
Last Updated: 2025-10-27
Results Overview
To determine whether 6 months (24 weeks) of neoadjuvant apalutamide prior to prostatectomy for intermediate risk prostate cancer results in a reduction of surgical pathology features at risk of pelvic RT, defined as pT3a, pT3b stage, N1 and/or positive surgical margin. All patients who receive at least 9 weeks of neoadjuvant therapy of apalutamide and undergo radical prostatectomy will be evaluable for the primary endpoint.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Assessed at time of surgical specimen microscopic evalution Assessed at time of surgical specimen microscopic evaluation
Results posted on
2025-10-27
Participant Flow
Between May 2018 and February 2020, 45 men were enrolled, initiated preoperative apalutamide, and were evaluable for safety outcomes. Of those, two patients withdrew consent prior to surgery, one patient stopped apalutamide at \<9 weeks after initiation, and two patients did not undergo a Radical Prostatectomy (RP)
Participant milestones
| Measure |
Open label apalutamide and surgery
apalutamide 240 mg/day orally for a total duration of 24 weeks, and RP plus ePLND was performed within 3 weeks of completing apalutamide
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Open label apalutamide and surgery
apalutamide 240 mg/day orally for a total duration of 24 weeks, and RP plus ePLND was performed within 3 weeks of completing apalutamide
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
"stopped apalutamide at <9 weeks after initiation"
|
1
|
|
Overall Study
Did not undergo RP
|
2
|
Baseline Characteristics
Apalutamide in Treating Patients With Prostate Cancer Before Radical Prostatectomy
Baseline characteristics by cohort
| Measure |
Open label apalutamide and surgery
n=40 Participants
apalutamide 240 mg/day orally for a total duration of 24 weeks, and RP plus ePLND was performed within 3 weeks of completing apalutamide
|
|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at time of surgical specimen microscopic evalution Assessed at time of surgical specimen microscopic evaluationTo determine whether 6 months (24 weeks) of neoadjuvant apalutamide prior to prostatectomy for intermediate risk prostate cancer results in a reduction of surgical pathology features at risk of pelvic RT, defined as pT3a, pT3b stage, N1 and/or positive surgical margin. All patients who receive at least 9 weeks of neoadjuvant therapy of apalutamide and undergo radical prostatectomy will be evaluable for the primary endpoint.
Outcome measures
| Measure |
Open label apalutamide and surgery
n=40 Participants
apalutamide 240 mg/day orally for a total duration of 24 weeks, and RP (radical prostatectomy) plus ePLND was performed within 3 weeks of completing apalutamide
|
|---|---|
|
Number of Adverse Surgical Pathology Features at Risk of Pelvic Radiation Therapy
|
16 Participants
|
SECONDARY outcome
Timeframe: From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.Incidence of treatment emergent adverse events (TEAEs). All patients who receive any dose of apalutamide will be evaluable for safety.
Outcome measures
| Measure |
Open label apalutamide and surgery
n=45 Participants
apalutamide 240 mg/day orally for a total duration of 24 weeks, and RP (radical prostatectomy) plus ePLND was performed within 3 weeks of completing apalutamide
|
|---|---|
|
Safety and Tolerability of 6 Months Neoadjuvant Apalutamide Followed by Radical Prostatectomy
Any TEAEs
|
45 Participants
|
|
Safety and Tolerability of 6 Months Neoadjuvant Apalutamide Followed by Radical Prostatectomy
Grade ≥3 TEAE
|
13 Participants
|
|
Safety and Tolerability of 6 Months Neoadjuvant Apalutamide Followed by Radical Prostatectomy
TEAE leading to discontinuation
|
4 Participants
|
SECONDARY outcome
Timeframe: Assessed at time of surgical specimen microscopic evaluationThe numbers of patients with \<6 mm total tumor volume in their surgical specimens, assessed by study Pathologist.
Outcome measures
| Measure |
Open label apalutamide and surgery
n=40 Participants
apalutamide 240 mg/day orally for a total duration of 24 weeks, and RP (radical prostatectomy) plus ePLND was performed within 3 weeks of completing apalutamide
|
|---|---|
|
Clinical Complete Responses (pT0) and "Near" Complete Responses (<6mm Total Tumor Volume)
|
0 Participants
|
SECONDARY outcome
Timeframe: From surgery through 3-year post-op follow upNumber of patients who had a PSA value of equal of more than 0.2 ng/dL after surgery and through 3 years of follow up.
Outcome measures
| Measure |
Open label apalutamide and surgery
n=40 Participants
apalutamide 240 mg/day orally for a total duration of 24 weeks, and RP (radical prostatectomy) plus ePLND was performed within 3 weeks of completing apalutamide
|
|---|---|
|
Biochemical Recurrence Rate
|
6 Participants
|
Adverse Events
Open label apalutamide and surgery
Serious events: 2 serious events
Other events: 45 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Open label apalutamide and surgery
n=45 participants at risk
apalutamide 240 mg/day orally for a total duration of 24 weeks, and RP (radical prostatectomy) plus ePLND was performed within 3 weeks of completing apalutamide
|
|---|---|
|
Cardiac disorders
Death NOS
|
2.2%
1/45 • Number of events 1 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
|
Gastrointestinal disorders
Enterocolitis
|
2.2%
1/45 • Number of events 1 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
|
Gastrointestinal disorders
Ileus
|
2.2%
1/45 • Number of events 1 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
Other adverse events
| Measure |
Open label apalutamide and surgery
n=45 participants at risk
apalutamide 240 mg/day orally for a total duration of 24 weeks, and RP (radical prostatectomy) plus ePLND was performed within 3 weeks of completing apalutamide
|
|---|---|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
22.2%
10/45 • Number of events 10 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
15/45 • Number of events 15 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
|
Metabolism and nutrition disorders
Anorexia
|
13.3%
6/45 • Number of events 6 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.2%
10/45 • Number of events 10 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
|
Blood and lymphatic system disorders
AST elevated
|
11.1%
5/45 • Number of events 5 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
|
Blood and lymphatic system disorders
ALT elevated
|
11.1%
5/45 • Number of events 5 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
5/45 • Number of events 5 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
|
Blood and lymphatic system disorders
Creatinine elevated
|
11.1%
5/45 • Number of events 5 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
|
General Disorders
Decreased libido
|
20.0%
9/45 • Number of events 9 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
|
General Disorders
Depression
|
13.3%
6/45 • Number of events 6 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
|
Gastrointestinal disorders
Diarrhea
|
8.9%
4/45 • Number of events 4 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
|
Nervous system disorders
Dizziness
|
13.3%
6/45 • Number of events 6 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
|
Gastrointestinal disorders
Dysgeusia
|
11.1%
5/45 • Number of events 5 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
|
Blood and lymphatic system disorders
Edema
|
6.7%
3/45 • Number of events 3 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
|
Blood and lymphatic system disorders
Elevated TSH
|
22.2%
10/45 • Number of events 10 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
|
Blood and lymphatic system disorders
Elevated testosterone
|
44.4%
20/45 • Number of events 20 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
|
General disorders
Fatigue
|
37.8%
17/45 • Number of events 19 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
|
Reproductive system and breast disorders
Gynecomastia
|
44.4%
20/45 • Number of events 20 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
22.2%
10/45 • Number of events 10 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
|
Nervous system disorders
Headache
|
11.1%
5/45 • Number of events 5 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
|
Nervous system disorders
Hypertension
|
13.3%
6/45 • Number of events 7 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
13.3%
6/45 • Number of events 6 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
|
Nervous system disorders
Insomnia
|
17.8%
8/45 • Number of events 8 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
24.4%
11/45 • Number of events 12 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
|
Metabolism and nutrition disorders
Weight loss
|
11.1%
5/45 • Number of events 5 • From initiation of apalutamide through 30 days post-surgery. For those participants who did not have surgery, we assessed the reported AEs until 30 days after the last dose of apalutamide.
|
Additional Information
Dr. John Davis
The University of Texas MD Anderson Cancer Center
Phone: (713) 792-3250
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place