Prostate CancerPhase 2337NCT03432897
BrUOG 337: Olaparib Prior to Radical Prostatectomy For Advanced Prostate Cancer Defects in DNA Repair Genes
A Phase 2 study testing Olaparib Pill and Prostatectomy in people with Prostate Cancer and Adenocarcinoma of the Prostate, run by Brown University at 1 site in United States.
Trial summary
This study will evaluate approximately 3 months of treatment with the drug olaparib in patients with prostate cancer. A capsule formulation of olaparib (tradename Lynparza™) is approved by the United States Food and Drug Administration (FDA) for the treatment of women with advanced BRCA-mutated ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Adenocarcinoma of the Prostate
- What is being tested?
- Olaparib Pill and Prostatectomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2018to 7 Dec 2021
- 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
- Biopsy confirmed adenocarcinoma of the prostate.
- High risk for recurrence after prostatectomy including any of the following
- Lymph node involvement by radiographic criteria
- T3 or T4 disease by radiographic criteria
- T2 disease and either PSA > 20 or Gleason 8,9 or 10
- Defects in any of the following genes:BRCA1, BRCA 2, ATM, CHEK1, CHEK2, FANCONIS ANEMIA (FANCL), HDAC2, PALB2, BARD1, BRIP1, CDK12, PPP2R2A, RAD51B, RAD51C, RAD51D, or RAD54L as assessed by Foundation Medicine FoundationOne assay on tumor tissue or cell-free DNA from peripheral blood via the FoundationACT assay.
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- No distant visceral metastases.
- No prior chemotherapy or radiation for prostate cancer or PARP inhibitor. Prior and current hormone therapy (< 6 months from start date on study) for prostate cancer is allowed. Patients are allowed to remain on hormone therapy on study.
- ECOG performance status 0-1.
- Age>18.
- Required entry laboratory parameters
- ANC≥ 1,500 cells/mm3;
- Hemoglobin > 10.0g/dL with no blood transfusion in the last 14 days
- Platelet count ≥100 x 109/L,
- Total bilirubin ≤ 1.5 x ULN,
- AST and ALT ≤ 2.5 x ULN
- Patients must have creatinine clearance estimated using the Cockcroft-Gault equation of ≥51 mL/min
- Life expectancy of at least 1 year as documented by treating physician.
- All Men must be willing to consent to using two highly effective contraception while on treatment and for at least 4 months (120 days) after last treatment on study
- Signed study-specific consent form prior to study entry.
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations- to be documented and submitted to BrUOG.
- Formalin fixed, paraffin embedded (FFPE) tumor sample from the primary cancer must be available for central testing coordinated by Rhode Island Hospital pathology. If there is not written confirmation of the availability of an archived tumor sample prior to enrollment the patient is not eligible for the study. Submit this written certification to BrUOG
- Patient agreed to not receiving any live virus and live bacterial vaccines while receiving study medication and during the 30 day follow up period. Patient should be made aware of this and it should be documented to BrUOG.
- Patient agreed to not consume grapefruit juice while on study treatment. Submit documentation patient was instructed and agreed.
Who cannot join
- Participation in another clinical study with an investigational anticancer product during the last 2 months (from day 1 of treatment on this trial). This pertains to treatment no trials the patient may only be seen in follow-up.
- Any previous treatment with PARP inhibitor for this or another cancer, including olaparib.
- Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer or other solid tumors including lymphomas (without bone marrow involvement) which was curatively treated with no evidence of disease for ≥5 years. Diagnosis date and treatment confirmation required to be sent to BrUOG. Certification from treating physician that patient is disease free is required.
- Resting ECG with QTc > 470 msec on 2 time-points within a 24 hour period or known family history of long QT syndrome
- Patients receiving any systemic chemotherapy or radiotherapy within 3 weeks prior to study treatment
- Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.
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- Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort ) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
- Concomitant use of the substrates of CYP3A4, CYP1A2, 2B6, 2C9, 2C19 and P-gp should be cautioned while on study.
- CYP3A4 - hormonal contraceptive, simvastatin, cisapride, cyclosporine, ergot alkaloids, fentanyl, pimozide, sirolimus, tacrolimus and quetiapine CYP1A2 - duloxetine, melatonin CYP2B6 - bupropion, efavirenz CYP2C9 - warfarin CYP2C19 - lansoprazole, omeprazole, S-mephenytoin P-gp - simvastatin, pravastatin, digoxin, dabigatran, colchicine OATP1B1 - bosentan, glibenclamide, repaglinide, statins and valsartan OCT1, MATE1, MATE2K - metformin OCT2 - serum creatinine OAT3 -furosemide, methotrexate
- Persistent toxicities deemed related to previous cancer therapy, excluding alopecia.
- Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
- Patients with brain metastases.
- Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any prior major surgery.
- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
- Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- Immunocompromised patients that according to treating investigator would increase their risk to protocol treatment, or Patients who are known to be serologically positive for human immunodeficiency virus (HIV).
- Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
- Patients with known active hepatitis (i.e. Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids
- 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 as long as not within 28 days from study registration).
- Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lifespan Cancer Institute: The Miriam and Rhode Island Hospitals
Providence, Rhode Island, 02903
About this study
Official title: BrUOG 337: Olaparib Prior to Radical Prostatectomy For Patients With Locally Advanced Prostate Cancer and Defects in DNA Repair Genes
This study will evaluate approximately 3 months of treatment with the drug olaparib in patients with prostate cancer. A capsule formulation of olaparib (tradename Lynparza™) is approved by the United States Food and Drug Administration (FDA) for the treatment of women with advanced BRCA-mutated ovarian cancer. Olaparib is an investigational drug in prostate cancer. A tablet formulation of olaparib is being tested in this study. It is a new formulation which is more convenient for patients than the approved capsule formulation because fewer tablets of olaparib need to be taken daily than with capsules.
The purpose of the study is to evaluate whether olaparib can reduce prostate cancer with defects in DNA repair genes when olaparib is given for approximately 3 months before surgery.
Read the detailed description
1.1 Primary Objective 1.1.1. To evaluate the Prostate Specific Antigen (PSA) response rate of olaparib prior to radical prostatectomy for patients with locally advanced prostate cancer and defects in DNA repair genes.
1.2 Secondary Objectives 1.2.1 To evaluate the PSA progression-free survival of olaparib and radical prostatectomy for patients with locally advanced prostate cancer and defects in DNA repair genes.
1.2.2 To evaluate the safety of olaparib prior to radical prostatectomy for patients with locally advanced prostate cancer
1.2.3 To evaluate the rate of defects in DNA repair genes in patients with newly diagnosed locally advanced prostate cancer.
- Conditions
- Prostate Cancer, Adenocarcinoma of the Prostate
- Being tested
- Olaparib Pill, Prostatectomy
- Keywords
- High risk, Defects, prostate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olaparib PillDrug
300 mg BID
ProstatectomyProcedure or surgery
22-42 days post Olaparib patients will undergo surgery
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Olaparib 300 mg BID q 4 weeks for up to 3 cycles. The 3rd cycle will not be given if patient is found to progress post cycle 2.
Between 22-42 days post Olaparib, patients will undergo a prostatectomy. Receives: Drug: Olaparib Pill; Procedure: Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Prostate Specific Antigen (PSA) Response
Response:Reduction of at least 50% in the prostate-specific antigen level from baseline Progression:A 25% increase in PSA from baseline
Baseline then approximately 8 weeks later and 2 weeks post Olaparib, approximately 10-14 weeks after baseline and then approximately every 6 months for 2 years in follow-up.
Measured: Throughout the trial for approximately 2 years
Secondary outcomes (2)
PSA Progression-free Survival of Olaparib and Radical Prostatectomy for Patients With Locally Advanced Prostate Cancer and Defects in DNA Repair Genes.
Evaluation by treating physician
Measured: Post treatment (approximately 8-12 weeks) and approximately every 6 months for 2 years.
Safety of Olaparib Prior to Radical Prostatectomy for Patients With Locally Advanced Prostate Cancer
Measured: Eight to 12 weeks prior to radical prostatectomy utilizing the descriptions and grading scales found in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 for grading all adverse events.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start25 May 2018
- Primary completion15 Dec 2020
- Study completion7 Dec 2021
Why it stopped: Lack of enrollment secondary to eligibility criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Rhode Island Hospital, The Miriam Hospital, AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Anthony Mega, MD, Principal investigator, BrUOG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432897
- Sponsor's protocol ID
- BrUOG 337
- Acronym
- 337
- Status last verified
- Jul 2025
- First submitted
- 5 Oct 2017
- Last updated
- 8 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nientiedt C, Duensing A, Zschabitz S, Jager D, Hohenfellner M, Stenzinger A, Duensing S. PARP inhibition in prostate cancer. Genes Chromosomes Cancer. 2021 May;60(5):344-351. doi: 10.1002/gcc.22903. Epub 2020 Oct 28.
PubMed 33084183
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BrUOG 337: Olaparib Prior to Radical Prostatectomy For Patients With Locally Advanced Prostate Cancer and Defects in DNA Repair Genes
- ClinicalTrials.gov ID
- NCT03432897
- Acronym / sponsor ID
- 337 / BrUOG 337
- Conditions
- Prostate Cancer, Adenocarcinoma of the Prostate
- Keywords
- High risk, Defects, prostate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment secondary to eligibility criteria
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Rhode Island Hospital, The Miriam Hospital, AstraZeneca
- Study start
- 25 May 2018 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Posted 3 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate approximately 3 months of treatment with the drug olaparib in patients with prostate cancer. A capsule formulation of olaparib (tradename Lynparza™) is approved by the United States Food and Drug Administration (FDA) for the treatment of women with advanced BRCA-mutated ovarian cancer. Olaparib is an investigational drug in prostate cancer. A tablet formulation of olaparib is being tested in this study. It is a new formulation which is more convenient for patients than the approved capsule formulation because fewer tablets of olaparib need to be taken daily than with capsules.
The purpose of the study is to evaluate whether olaparib can reduce prostate cancer with defects in DNA repair genes when olaparib is given for approximately 3 months before surgery.
Detailed description
1.1 Primary Objective 1.1.1. To evaluate the Prostate Specific Antigen (PSA) response rate of olaparib prior to radical prostatectomy for patients with locally advanced prostate cancer and defects in DNA repair genes.
1.2 Secondary Objectives 1.2.1 To evaluate the PSA progression-free survival of olaparib and radical prostatectomy for patients with locally advanced prostate cancer and defects in DNA repair genes.
1.2.2 To evaluate the safety of olaparib prior to radical prostatectomy for patients with locally advanced prostate cancer
1.2.3 To evaluate the rate of defects in DNA repair genes in patients with newly diagnosed locally advanced prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Olaparib Pill, Procedure: ProstatectomyOlaparib 300 mg BID q 4 weeks for up to 3 cycles. The 3rd cycle will not be given if patient is found to progress post cycle 2. Between 22-42 days post Olaparib, patients will undergo a prostatectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Biopsy confirmed adenocarcinoma of the prostate.
- High risk for recurrence after prostatectomy including any of the following
- Defects in any of the following genes:BRCA1, BRCA 2, ATM, CHEK1, CHEK2, FANCONIS ANEMIA (FANCL), HDAC2, PALB2, BARD1, BRIP1, CDK12, PPP2R2A, RAD51B, RAD51C, RAD51D, or RAD54L as assessed by Foundation Medicine FoundationOne assay on tumor tissue or cell-free DNA from peripheral blood via the FoundationACT assay.
- No distant visceral metastases.
- No prior chemotherapy or radiation for prostate cancer or PARP inhibitor. Prior and current hormone therapy (< 6 months from start date on study) for prostate cancer is allowed. Patients are allowed to remain on hormone therapy on study.
Key exclusion criteria (21 listed)
- Participation in another clinical study with an investigational anticancer product during the last 2 months (from day 1 of treatment on this trial). This pertains to treatment no trials the patient may only be seen in follow-up.
- Any previous treatment with PARP inhibitor for this or another cancer, including olaparib.
- Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer or other solid tumors including lymphomas (without bone marrow involvement) which was curatively treated with no evidence of disease for ≥5 years. Diagnosis date and treatment confirmation required to be sent to BrUOG. Certification from treating physician that patient is disease free is required.
- Resting ECG with QTc > 470 msec on 2 time-points within a 24 hour period or known family history of long QT syndrome
- Patients receiving any systemic chemotherapy or radiotherapy within 3 weeks prior to study treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olaparib Pill300 mg BID | Drug | Treatment |
| Prostatectomy22-42 days post Olaparib patients will undergo surgery | Procedure or surgery | Treatment |
Primary outcome
Number of Participants With Prostate Specific Antigen (PSA) Response
Time frame: Throughout the trial for approximately 2 years
Response:Reduction of at least 50% in the prostate-specific antigen level from baseline Progression:A 25% increase in PSA from baseline Baseline then approximately 8 weeks later and 2 weeks post Olaparib, approximately 10-14 weeks after baseline and then approximately every 6 months for 2 years in follow-up.
2 secondary outcomes
PSA Progression-free Survival of Olaparib and Radical Prostatectomy for Patients With Locally Advanced Prostate Cancer and Defects in DNA Repair Genes.
Time frame: Post treatment (approximately 8-12 weeks) and approximately every 6 months for 2 years.
Safety of Olaparib Prior to Radical Prostatectomy for Patients With Locally Advanced Prostate Cancer
Time frame: Eight to 12 weeks prior to radical prostatectomy utilizing the descriptions and grading scales found in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 for grading all adverse events.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33084183Nientiedt C, Duensing A, Zschabitz S, Jager D, Hohenfellner M, Stenzinger A, Duensing S. PARP inhibition in prostate cancer. Genes Chromosomes Cancer. 2021 May;60(5):344-351. doi: 10.1002/gcc.22903. Epub 2020 Oct 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Mega, MD principal investigator
BrUOG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olaparib Pill and Prostatectomy in people with Prostate Cancer and Adenocarcinoma of the Prostate, run by Brown University at 1 site 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 24 inclusion and 21 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: stopped early, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 Feb 2022). 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?
Number of Participants With Prostate Specific Antigen (PSA) Response (time frame: Throughout the trial for approximately 2 years). 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 NCT03432897, which also lists 1 linked publication.
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 8 Jul 2025.