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Prostate CancerPhase 2NCT03787680

Targeting Resistant Prostate Cancer With ATR and PARP Inhibition (TRAP Trial)

A Phase 2 study testing Olaparib and AZD6738 in people with Prostate Cancer, run by University of Michigan Rogel Cancer Center at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to test the effectiveness (how well the drugs work), safety, and tolerability of the investigational drug combination of olaparib and AZD6738 for all patients with metastatic castration-resistant prostate cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Olaparib and AZD6738
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
3 sitesUnited States
Study dates
31 Oct 2019to Aug 2028
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of informed consent prior to any study specific procedures
  • Male ages 18 years and older at time of signing the informed consent form
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 42 days prior to registration
  • Histologic or cytologic proof of prostate adenocarcinoma (excluding small-cell or neuroendocrine pathologies)
  • Metastatic prostate cancer on CT, MRI or Bone scan
  • Must have disease progression (while testosterone level is under 50 ng/dl) on prior therapy prior to study entry defined as one (or more) of the following:
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  • PSA progression defined as continuously rising PSA values measured a minimum of 1 week apart with a minimal starting value of 1.0 ng/mL
  • Progression of bidimensionally measurable soft tissue or nodal metastasis by CT or MRI based on RECIST, v1.1
  • Prior treatment with at least one of the following:
  • One line of therapy in mCRPC
  • Second generation anti-androgen (e.g. abiraterone, enzalutamide or apalutamide) within the hormone-sensitive phase of disease AND progression occurs while on therapy
  • Patients must be withdrawn from prior therapy for ≥3 weeks (patients may remain on prior prednisone up to 10 mg total daily exposure at provider's discretion) at planned time of treatment start.
  • Agree to undergo a biopsy of at least one metastatic site (if feasible) to determine DNA repair status, unless prior metastatic tissue underwent next-generation sequencing in a CLIA certified lab or known germline loss of BRCA1, BRCA2 or ATM. If no site is reachable, or first biopsy insufficient/unsuccessful, circulating tumor DNA may be obtained.
  • Treated with continuous androgen deprivation therapy (either surgical castration or LHRH agonist/antagonist) with documented castrate level of serum testosterone (<50 ng/dL). A stable dose of bisphosphonate or denosumab for bone metastases should be continued as long as started at least 5 days prior to C1D1 planned start day.
  • At the time of planned treatment start (C1D1), at least 21 or more days will have elapsed from palliative radiation (with the exception of radiation to >30% of bone marrow or with a wide field of radiation, this requires 28 or more days).
  • Patient must have normal organ and bone marrow function measured within 42 days prior to registration as defined below
  • Hemoglobin ≥10 g/dL (with no blood transfusion or erythropoietin use within the past 42 days)
  • Absolute neutrophil count ≥1.5x109/L
  • Platelet count ≥100x109/L (with no platelet transfusions within last 42 days)
  • Total bilirubin <1.5x ULN (unless the patient has documented Gilbert's disease and <2.0x ULN should be used)
  • AST or ALT ≤ 2.5x ULN, unless liver metastases are present in which case they cannot be ≥5x ULN
  • Glomerular filtration rate (GFR) ≥51 mL/min, as assessed using the Cockcroft- Gault equation
  • Estimated life expectancy ≥16 weeks
  • Male patients who are sexually active must be willing to use barrier contraception for the duration of the study and for 1 week after the last study drug administration, with all sexual partners. Male patients must use a condom during treatment and for 6 months after the last dose of study drug(s) when having sexual intercourse with a pregnant woman or with a woman of childbearing potential and must not donate sperm for 6 months after the last dose of study drug. Female partners of male patients should also use a highly effective form of contraception (per protocol) for 6 months after the last dose of study drug(s) if they are of childbearing potential. True abstinence is an acceptable form of contraception and must be documented as such.
  • Patient is willing and able to comply with the protocol for the duration of the study, including undergoing biopsy (if warranted), treatment, scheduled visits and examinations

Who cannot join

  • A diagnosis of ataxia telangiectasia
  • Prior treatment with a PARP inhibitor (e.g. olaparib, veliparib, niraparib, rucaparib), AZD6738 or other DNA-damage response agents (e.g. cisplatin or carboplatin)
  • Cytotoxic chemotherapy, first- or second-generation antiandrogen or CYP17 inhibitors are not permitted within 21 days or 5 half-lives of registration (whichever is longest) of planned treatment start. For clarity, enzalutamide requires 5 weeks washout.
  • Major surgery < 2 weeks prior to enrolment; patients must have recovered from any effects of major surgery
  • Persistent toxicities (≥CTCAE Grade 2) caused by previous cancer therapy, besides Grade 2 alopecia and Grade 2 neuropathy (these are allowed).
  • Patients with current or prior MDS/AML or with features suggestive of MDS/AML
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  • Any other malignancy which has been active or treated within the past 3 years, with the exception of non-melanomatous skin cancer, or Ta bladder cancer
  • Patients with active brain metastases are excluded because of unknown penetration into the CNS. A confirmatory scan for asymptomatic patients is not required. Patients with a history of treated central nervous system (CNS) metastases are eligible provided they meet all of the following criteria: disease outside the CNS is present, no clinical evidence of progression since completion of CNS-directed therapy, minimum 3 weeks between completion of radiotherapy and registration and recovery from significant (Grade ≥ 3) acute toxicity with no ongoing requirement for >10 mg of prednisone per day or an equivalent dose of other corticosteroid. If a patient must remain on steroids, they must have started the steady dose at least 28 days prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days prior to study treatment.
  • Any of the following cardiac disease currently or within the last 6 months:
  • Unstable angina pectoris
  • Congestive heart failure (by New York Heart Association ≥ Class 2) or known reduced LVEF < 55%
  • Acute myocardial infarction
  • Conduction abnormality not controlled with pacemaker or medication (e.g. complete left bundle branch block or third-degree heart block)
  • Significant ventricular or supraventricular arrhythmias (patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible).
  • Uncontrolled hypertension (Grade 2 or above) requiring urgent (for example, adjusting medications within 24 hours) clinical intervention
  • Patients at risk of brain perfusion problems, e.g. TIAs or history of pre- syncope or syncopal episodes unexplained by reversible causes
  • Mean resting corrected QT interval >450, obtained from 3 ECGs 2-5 minutes apart using the Fredericia formula. Absence of any factors that increase the risk of QTc prolongation or risk of arrhythmic such as congenital long QT syndrome, immediate family history of long QT syndrome or unexplained sudden death under 40 year of age. Patients with relative hypotension (<90/60 mmHg) or previously known clinically relevant orthostatic hypotension defined as a postural hypotension ≥20 mmHg
  • Concomitant use of known potent or moderate cytochrome P (CYP) 3A inhibitors (e.g. itraconazole, ciprofloxacin, diltiazem) require 2-week washout prior to planned C1D1. Concomitant use of strong or moderate CYP3A inducers (e.g. phenobarbital, enzalutamide, modafinil require 5-week washout for enzalutamide or phenobarbital and 3 week washout for all others, per protocol.
  • As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases that places the patient at unacceptable risk of toxicity or non-compliance. Examples include, but are not limited to, active bleeding diatheses, renal transplant, uncontrolled major seizure disorder, severe COPD, superior vena cava syndrome, extensive bilateral lung disease on High Resolution CT scan, severe Parkinson's disease, active inflammatory bowel disease, psychiatric condition, immunocompromised patients or active infection including any patient known to have hepatitis B, hepatitis C and human immunodeficiency virus (HIV) or requiring systemic antibiotics, antifungals or antiviral drugs. Screening for chronic conditions is not required
  • A known hypersensitivity to olaparib, AZD6738 or any excipient of the product or any contraindication to the combination anti-cancer agent as per local prescribing information
  • Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with the absorption of the study medication, refractory nausea and vomiting, chronic gastrointestinal diseases or previous significant bowel resection, with clinically significant sequelae that would preclude adequate absorption of AZD6738
  • Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
  • Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable, for timing refer to inclusion criteria no.12)
  • Involvement in the planning and/or conduct of the study
  • Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
  • Previous enrolment in the present study.
  • Has received a live vaccination with 2 weeks of enrollment.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of Michigan Hospital

    Ann Arbor, Michigan, 48109

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

Other trials in United States

About this study

Official title: A Multi-Center Phase II Study Testing the Activity of Olaparib and AZD6738 (ATR Inhibitor) in Metastatic Castration-Resistant Prostate Cancer

The purpose of this study is to test the effectiveness (how well the drugs work), safety, and tolerability of the investigational drug combination of olaparib and AZD6738 for all patients with metastatic castration-resistant prostate cancer.

Conditions
Prostate Cancer
Being tested
Olaparib, AZD6738
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OlaparibDrug

    Also called AZD2281, ceralasertib

    300 mg by mouth twice a day for days 1-28 of a 28-day cycle.

  • AZD6738Drug

    160 mg by mouth daily for days 1-7 of a 28-day cycle.

Study groups in NCT03787680
Study groupRoleWhat they receive
Cohort 1 (DRPro)ExperimentalPatients with metastatic castration-resistant prostate cancer (mCRPC) who are DNA repair proficient (DRPro).
Receives: Drug: Olaparib; Drug: AZD6738
Cohort 2 (DRDef)ExperimentalPatients with metastatic castration-resistant prostate cancer (mCRPC) who are DNA repair deficient (DRDef).
Receives: Drug: Olaparib; Drug: AZD6738

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Response (Complete Response [CR] or Partial Response [PR]) in DNA Repair Proficient (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).

    Measured: Up to 30 days after study completion (an average of 1 year)

Secondary outcomes (13)

  1. Rate of Response (Complete Response [CR] or Partial Response [PR]) in DNA Repair Deficient (DRDef) Patients

    Evaluated per radiographic response according to RECIST v1.1 or PSA (≥50% decline).

    Measured: Up to 30 days after study completion (an average of 1 year for study completion)

  2. Progression-free Survival (PFS) in DRPro Patients

    Duration of time from start of treatment to time of progression (based only on radiographic progression or clinical decline/death).

    Measured: Up to 30 days after study completion (an average of 1 year for study completion)

  3. Progression-free Survival (PFS) in DRDef Patients

    Duration of time from start of treatment to time of progression (based only on radiographic progression or clinical decline/death).

    Measured: Up to 30 days after study completion (an average of 1 year for study completion)

  4. Radiographic Response Rate in DRPro Patients

    Evaluated according to RECIST v1.1.

    Measured: Up to 30 days after study completion (an average of 1 year for study completion)

  5. Radiographic Response Rate in DRDef Patients

    Evaluated according to RECIST v1.1.

    Measured: Up to 30 days after study completion (an average of 1 year for study completion)

  6. PSA Progression-free Survival in DRPro Patients

    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.

    Measured: Up to 30 days after study completion (an average of 1 year for study completion)

  7. PSA Progression-free Survival in DRDef Patients

    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.

    Measured: Up to 30 days after study completion (an average of 1 year for study completion)

  8. PSA Response Rate in DRPro Patients

    Rate of achieving PSA response rate of ≤ 0.2 ng/ml, 50% decline, or 90% decline from entry PSA and confirmed 4 weeks later

    Measured: Up to 30 days after study completion (an average of 1 year for study completion)

  9. PSA Response Rate in DRDef Patients

    Rate of achieving PSA response rate of ≤ 0.2 ng/ml, 50% decline, or 90% decline from entry PSA and confirmed 4 weeks later

    Measured: Up to 30 days after study completion (an average of 1 year for study completion)

  10. Duration of Combined Radiographic and PSA Response in DRPro Patients

    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.

    Measured: Up to 30 days after study completion (an average of 1 year for study completion)

  11. Duration of Combined Radiographic and PSA Response in DRDef Patients

    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.

    Measured: Up to 30 days after study completion (an average of 1 year for study completion)

  12. Adverse Events

    NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

    Measured: Up to 30 days after study completion (an average of 1 year for study completion)

  13. Incidence of Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML) and New Primary Malignancy

    Measured: Up to 5 years after study completion (an average of 1 year for study completion)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2018
  2. Study start31 Oct 2019
  3. Primary completion26 Jan 2023
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03787680
Sponsor's protocol ID
UMCC 2018.108
Other IDs
HUM00152799
Status last verified
Mar 2026
First submitted
24 Dec 2018
Last updated
23 Mar 2026
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Olaparib and AZD6738 in people with Prostate Cancer, run by University of Michigan Rogel Cancer Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Response (Complete Response [CR] or Partial Response [PR]) in DNA Repair Proficient (DRPro) Patients (time frame: Up to 30 days after study completion (an average of 1 year)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03787680.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.

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