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About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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.
ECOG performance status 0-1.
Age>18.
Required entry laboratory parameters
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.
Exclusion criteria
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
Primary purpose
Allocation
Interventional model
Masking
1 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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