I234

I234 Details
Status: Closed
Activation Date: 2017DEC12
Closing Date: 2024FEB27
Phase: II

Description: Prostate Cancer Biomarker Enrichment and Treatment Selection (PC_BETS) Study - Master Screening Protocol

Eligibility: Patients (>=18 years old, ECOG PS 0-1) must have histologically confirmed mCRPC with no evidence of small cell/neuroendocrine differentiation. Patients must consent to undergo genomic screening. Clinically/radiologically documented disease (measurable or non-measurable). Evidence of biochemical and/or radiological disease progression in the setting of surgical or medical castration. Patients must have received prior hormonal treatment with at least one of abiraterone acetate, enzalutamide, ARN-509 TAK-700 and TOK-001. Prior anti-androgen therapy must have been discontinued >=28 days (>=42 days for bicalutamide) prior to registration. Maximum of one prior regimen of cytotoxic chemotherapy permitted. Prior immunotherapy, vaccines and oncolytic viruses permitted. Prior/concurrent CDK or mTOR inhibitors, strontium-89, systemic corticosteriods equivalent to prednisone >10 mg daily not allowed.

Objective: Primary Objective - To centrally genotype cfDNA from patients with mCRPC progressing after a "next-generation" AR-pathway inhibitor in order to facilitate accrual to targeted therapy trials and then to assess the clinical benefit rate (CBR), of each Study Drug. Secondary Objectives - To determine the effect of each Study Drug on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of each Study Drug in mCRPC patients. Tertiary Objectives - To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation.

Participation: Limited to invited centres

Lay Description: The purpose of the pre-study screening is to test for DNA abnormalities or "markers". This testing will be done on a sample of your blood to see whether or not you are eligible to take part in one of the main studies. Each study will be looking at what effects a new drug or drugs has on you and your prostate cancer and will also be looking at the side effects of treatment. The researchers doing the main studies will be looking to see if the "markers" that were identified in your screening sample can help predict which patients are most likely to be helped by that drug or drugs and to see how the cancer cells respond to it/them.

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Hide Tissue Samples

Disease Site	Trial Code	Patients Accrued	Patients - Blocks	Patients - Slides	Patients - Blocks and/or Slides
IND	I234	549	99	43	118

Hide TMA Samples

(Core size is 0.6 mm)

Disease Site	Trial Code	Patients Accrued	TMA Blocks	Patients on TMA Blocks
IND	I234	549	0	0

Hide Fluid Samples

Disease Site	Trial Code	Patients Accrued	Patients - Whole Blood	Patients - Cellular Component of Blood	Patients - DNA extracted from Blood	Patients - RNA extracted from Blood	Patients - Plasma	Patients - Serum	Patients - Urine	Patients - Buccal
IND	I234	549	0	0	0	0	0	0	0	0