Trial Outcomes & Findings for Targeting Resistant Prostate Cancer With ATR and PARP Inhibition (TRAP Trial) (NCT NCT03787680)
NCT ID: NCT03787680
Last Updated: 2026-03-23
Results Overview
Evaluated per radiographic response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or by Prostate Specific Antigen (PSA) (≥50% decline).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
Up to 30 days after study completion (an average of 1 year)
Results posted on
2026-03-23
Participant Flow
Participant milestones
| Measure |
Cohort 1 (DRPro)
Patients with metastatic castration-resistant prostate cancer (mCRPC) who are DNA repair proficient (DRPro).
Olaparib: 300 mg by mouth twice a day for days 1-28 of a 28-day cycle.
AZD6738: 160 mg by mouth daily for days 1-7 of a 28-day cycle.
|
Cohort 2 (DRDef)
Patients with metastatic castration-resistant prostate cancer (mCRPC) who are DNA repair deficient (DRDef).
Olaparib: 300 mg by mouth twice a day for days 1-28 of a 28-day cycle.
AZD6738: 160 mg by mouth daily for days 1-7 of a 28-day cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
12
|
|
Overall Study
COMPLETED
|
26
|
5
|
|
Overall Study
NOT COMPLETED
|
11
|
7
|
Reasons for withdrawal
| Measure |
Cohort 1 (DRPro)
Patients with metastatic castration-resistant prostate cancer (mCRPC) who are DNA repair proficient (DRPro).
Olaparib: 300 mg by mouth twice a day for days 1-28 of a 28-day cycle.
AZD6738: 160 mg by mouth daily for days 1-7 of a 28-day cycle.
|
Cohort 2 (DRDef)
Patients with metastatic castration-resistant prostate cancer (mCRPC) who are DNA repair deficient (DRDef).
Olaparib: 300 mg by mouth twice a day for days 1-28 of a 28-day cycle.
AZD6738: 160 mg by mouth daily for days 1-7 of a 28-day cycle.
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
3
|
|
Overall Study
Adverse Event
|
7
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Targeting Resistant Prostate Cancer With ATR and PARP Inhibition (TRAP Trial)
Baseline characteristics by cohort
| Measure |
Cohort 1 (DRPro)
n=37 Participants
Patients with metastatic castration-resistant prostate cancer (mCRPC) who are DNA repair proficient (DRPro).
Olaparib: 300 mg by mouth twice a day for days 1-28 of a 28-day cycle.
AZD6738: 160 mg by mouth daily for days 1-7 of a 28-day cycle.
|
Cohort 2 (DRDef)
n=12 Participants
Patients with metastatic castration-resistant prostate cancer (mCRPC) who are DNA repair deficient (DRDef).
Olaparib: 300 mg by mouth twice a day for days 1-28 of a 28-day cycle.
AZD6738: 160 mg by mouth daily for days 1-7 of a 28-day cycle.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants
|
4 Participants
n=8 Participants
|
14 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=10 Participants
|
8 Participants
n=8 Participants
|
35 Participants
n=18 Participants
|
|
Age, Continuous
|
70.2 years
n=10 Participants
|
67.9 years
n=8 Participants
|
69 years
n=18 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=10 Participants
|
12 Participants
n=8 Participants
|
49 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=10 Participants
|
10 Participants
n=8 Participants
|
44 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=10 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=10 Participants
|
12 Participants
n=8 Participants
|
40 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=10 Participants
|
12 participants
n=8 Participants
|
49 participants
n=18 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after study completion (an average of 1 year)Population: this endpoint only applies to DRPro patients
Evaluated per radiographic response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or by Prostate Specific Antigen (PSA) (≥50% decline).
Outcome measures
| Measure |
Cohort 1 (DRPro)
n=37 Participants
Patients with metastatic castration-resistant prostate cancer (mCRPC) who are DNA repair proficient (DRPro).
Olaparib: 300 mg by mouth twice a day for days 1-28 of a 28-day cycle.
AZD6738: 160 mg by mouth daily for days 1-7 of a 28-day cycle.
|
Cohort 2 (DRDef)
Patients with metastatic castration-resistant prostate cancer (mCRPC) who are DNA repair deficient (DRDef).
Olaparib: 300 mg by mouth twice a day for days 1-28 of a 28-day cycle.
AZD6738: 160 mg by mouth daily for days 1-7 of a 28-day cycle.
|
|---|---|---|
|
Rate of Response (Complete Response [CR] or Partial Response [PR]) in DNA Repair Proficient (DRPro) Patients
|
11.4 percentage of patients
|
—
|
SECONDARY outcome
Timeframe: Up to 30 days after study completion (an average of 1 year for study completion)Evaluated per radiographic response according to RECIST v1.1 or PSA (≥50% decline).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days after study completion (an average of 1 year for study completion)Duration of time from start of treatment to time of progression (based only on radiographic progression or clinical decline/death).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days after study completion (an average of 1 year for study completion)Duration of time from start of treatment to time of progression (based only on radiographic progression or clinical decline/death).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days after study completion (an average of 1 year for study completion)Evaluated according to RECIST v1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days after study completion (an average of 1 year for study completion)Evaluated according to RECIST v1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days after study completion (an average of 1 year for study completion)Composite of survival and duration of PSA control as defined by time from start of therapy to first PSA increase ≥ 25% and ≥2 ng/ml above the nadir and confirmed by a second value at or beyond 4 weeks later.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days after study completion (an average of 1 year for study completion)Composite of survival and duration of PSA control as defined by time from start of therapy to first PSA increase ≥ 25% and ≥2 ng/ml above the nadir and confirmed by a second value at or beyond 4 weeks later.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days after study completion (an average of 1 year for study completion)Rate of achieving PSA response rate of ≤ 0.2 ng/ml, 50% decline, or 90% decline from entry PSA and confirmed 4 weeks later
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days after study completion (an average of 1 year for study completion)Rate of achieving PSA response rate of ≤ 0.2 ng/ml, 50% decline, or 90% decline from entry PSA and confirmed 4 weeks later
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days after study completion (an average of 1 year for study completion)Time from first documented response (RECIST v1.1 CR/PR or PSA decline ≥50%) until death, recurrent or progressive disease (based on RECIST v1.1) or first PSA increase ≥ 25% and ≥2 ng/ml above the PSA nadir.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days after study completion (an average of 1 year for study completion)Time from first documented response (RECIST v1.1 CR/PR or PSA decline ≥50%) until death, recurrent or progressive disease (based on RECIST v1.1) or first PSA increase ≥ 25% and ≥2 ng/ml above the PSA nadir.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days after study completion (an average of 1 year for study completion)NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 years after study completion (an average of 1 year for study completion)Outcome measures
Outcome data not reported
Adverse Events
Cohort 1 (DRPro)
Serious events: 2 serious events
Other events: 35 other events
Deaths: 22 deaths
Cohort 2 (DRDef)
Serious events: 4 serious events
Other events: 11 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Cohort 1 (DRPro)
n=37 participants at risk
Patients with metastatic castration-resistant prostate cancer (mCRPC) who are DNA repair proficient (DRPro).
Olaparib: 300 mg by mouth twice a day for days 1-28 of a 28-day cycle.
AZD6738: 160 mg by mouth daily for days 1-7 of a 28-day cycle.
|
Cohort 2 (DRDef)
n=12 participants at risk
Patients with metastatic castration-resistant prostate cancer (mCRPC) who are DNA repair deficient (DRDef).
Olaparib: 300 mg by mouth twice a day for days 1-28 of a 28-day cycle.
AZD6738: 160 mg by mouth daily for days 1-7 of a 28-day cycle.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
16.7%
2/12 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection
|
2.7%
1/37 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
0.00%
0/12 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
8.3%
1/12 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/37 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
8.3%
1/12 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Vascular disorders
Thromboembolic event
|
2.7%
1/37 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
0.00%
0/12 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
Other adverse events
| Measure |
Cohort 1 (DRPro)
n=37 participants at risk
Patients with metastatic castration-resistant prostate cancer (mCRPC) who are DNA repair proficient (DRPro).
Olaparib: 300 mg by mouth twice a day for days 1-28 of a 28-day cycle.
AZD6738: 160 mg by mouth daily for days 1-7 of a 28-day cycle.
|
Cohort 2 (DRDef)
n=12 participants at risk
Patients with metastatic castration-resistant prostate cancer (mCRPC) who are DNA repair deficient (DRDef).
Olaparib: 300 mg by mouth twice a day for days 1-28 of a 28-day cycle.
AZD6738: 160 mg by mouth daily for days 1-7 of a 28-day cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
64.9%
24/37 • Number of events 69 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
66.7%
8/12 • Number of events 23 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Metabolism and nutrition disorders
Anorexia
|
18.9%
7/37 • Number of events 10 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
25.0%
3/12 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Investigations
Creatinine increased
|
13.5%
5/37 • Number of events 8 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
16.7%
2/12 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.9%
7/37 • Number of events 8 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
16.7%
2/12 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
General disorders
Fatigue
|
48.6%
18/37 • Number of events 30 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
50.0%
6/12 • Number of events 9 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.8%
4/37 • Number of events 12 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
8.3%
1/12 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.8%
4/37 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
0.00%
0/12 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Investigations
Lymphocyte count decreased
|
13.5%
5/37 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
16.7%
2/12 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Gastrointestinal disorders
Nausea
|
48.6%
18/37 • Number of events 25 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
50.0%
6/12 • Number of events 10 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Investigations
Platelet count decreased
|
13.5%
5/37 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
8.3%
1/12 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
|
Investigations
White blood cell decreased
|
18.9%
7/37 • Number of events 17 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
16.7%
2/12 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
|
Additional Information
Cancer Center ClinicalTrials.gov Admin
University of Michigan Rogel Cancer Center
Phone: 734-936-9499
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place