Targeting cancer care with the use of genetic profiling - BARCODE 2

Overview

No summary available.

Registry

who.int

Start Date

September 23, 2016

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

•For Part 1 (genetic screening) of the study:
•1\.Age \= 18 years.
•2\.Histologically confirmed prostate adenocarcinoma. A copy of the original histology report from biopsy or surgery must be obtained.
•3\.Castration\-resistant disease defined as biochemical or radiological progression on/after treatment with orchidectomy or LHRH analogues as per PCWG2 criteria.
•4\.Confirmed metastatic disease on conventional imaging methods such as CT, bone scan or PET imaging.
•5\.Current or previous treatment including docetaxel and/or enzalutamide/ abiraterone
•6\.Adequate renal function measured by calculated GFR (Cockcroft\-Gault) \>30ml/min. This must be documented within 7 days of registration. If a patient had renal dysfunction that is expected to improve, they may be considered for part 1 of the study
•7\.Adequate haematological function (haemoglobin \=10g/dl, neutrophil count \>1\.5x109/L and platelets \>100x109/L). This must be documented within 7 days of registration.
•8\.WHO performance status 0\-2 as assessed and documented by study doctor.
•9\.Life expectancy \>12 weeks

•Exclusion Criteria (for part 1 and 2\)
•1\.Critical organ metastases (e.g. spinal metastases with risk of cord compression) as documented on most recent imaging report.
•2\.Patients with bleeding tumours.
•3\.Previous treatment with a platinum chemotherapy drug for prostate cancer.
•4\.Previous treatment with a PARP inhibitor
•5\.Patients with a history of severe allergic to carboplatin or other platinum\-containing compounds
•6\.Patients unfit for chemotherapy or those with ongoing neuropathy \>grade 1 (sensory or motor) according to NCI CTCAE V4\.02\.
•7\.Known and documented hearing impairment
•8\.Other active malignancies or previous malignancies likely, in the PI’s opinion, to impact on management of mCRPC.
•9\.Significant documented cardiovascular disease: severe/unstable angina, myocardial infarction less than 6 months prior to trial entry, arterial thrombotic events less than 6 months prior to trial entry, clinically significant cardiac failure requiring treatment (NYHA II\-IV).