Phase II Trial of Rucaparib in Patients with Metastatic Hormone-Sensitive Prostate Cancer Harboring Germline DNA Repair Gene Mutations (TRIUMPH)
Johns Hopkins Kimmel Cancer Center in Baltimore
To discover the effectiveness and safety of the study drug rucaparib in lowering prostate-specific antigen (PSA) levels in men with metastatic prostate cancer who have not been treated with androgen deprivation therapy and who have an inherited mutation in a gene involved in repairing DNA damage.
Inclusion Criteria:Histological or cytologic proof of adenocarcinoma of the prostate Gene Mutation present that is responsive to a PARP inhibitor. Germline testing will not be offered as an eligibility screen. Must be ineligible or declined hormone therapyAbsolute PSA equal to 2.0 ng/ml at screening. Bone and CT scan showing metastatic disease Serum testosterone equal to 100 ng/dl. Must have normal organ and bone marrow function measured by lab work within 28 days of first dose of study drug. Mandatory Core Tumor Biopsy prior to treatment (Optional biopsy at week 12 of treatment)Exclusion Criteria:Active second malignancy (history of non-melanoma skin cancers and superficial bladder cancers are allowed)• Prior hormone treatment in the past 6 months. The total duration of prior ADT should not exceed 24 months.• Pain due to bone metastases requiring narcotic analgesics.• Prior treatment with intravenous chemotherapy.• Use of any prohibited concomitant medications within the prior 2 weeks of starting study.• Participation in another clinical study with an investigational product during the last 1 month. • Any previous treatment with a PARP inhibitor, including rucaparib..• Major surgery within 2 weeks of starting study treatment, and must have recovered from any effects of any major surgery.• Good cardiac function--Uncontrolled ventricular arrhythmia, recent heart attack within 6 months prior to first dose of study drugImmunocompromised patients; (Blood test positive for HIV, active hepatitis A, B or C) • Whole blood transfusions in the last 30 days prior to entry to the study.
Screening evaluations within 28 days of first dose of study drug. Core Biopsy within 7 days of the first dose of study drug. Each cycle is 28 days in length. Day 1 of each cycle involves lab work, appointment and dispensing of study drug. Re-staging scans every 3 cycles.
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