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Prostate Cancer Metastatic clinical trials

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NCT ID: NCT03089099 Recruiting - Clinical trials for Prostate Cancer Metastatic

Expression of Molecular Markers in Circulating Tumor Cells of Metastatic Castration-Resistant Prostate Cancer

Start date: April 24, 2017
Phase: N/A
Study type: Observational

As prostate cancer progresses into castration-resistant stage from initial hormone-sensitive status, the biological behavior of tumor cells that dissociated from primary lesions changed. Considered a "liquid biopsy," these circulating tumor cells (CTCs) can show how a patient's cancer responded to treatments. The purpose of this study is to determine whether sequentially analyzing the expression of molecular markers in high volume circulating tumor cells in metastatic castration-resistant prostate cancer patients can predict the therapeutic effects and outcomes of these patients.

NCT ID: NCT03024216 Completed - Clinical trials for Prostate Cancer Metastatic

Clinical Study of Atezolizumab (Anti-PD-L1) and Sipuleucel-T in Patients With Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant Prostate Cancer

Start date: February 6, 2017
Phase: Phase 1
Study type: Interventional

The purpose of the study is to compare the safety and tolerability of sequential atezolizumab followed by sipuleucel-T (Arm 1) vs. sipuleucel-T followed by atezolizumab (Arm 2) in patients who have asymptomatic or minimally symptomatic metastatic CRPC, not previously treated with docetaxel or cabazitaxel.

NCT ID: NCT02964988 Terminated - Bone Metastases Clinical Trials

uPAR PET/CT in Radium-223-dichloride Treatment of Patients With Metastatic Castration-resistant Prostate Cancer

Start date: January 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the applicability of urokinase plasminogen activator receptor (uPAR) Positron Emission Tomography (PET) / CT molecular imaging in patients with metastatic castration-resistant prostate cancer (mCRPC)

NCT ID: NCT02961257 Completed - Clinical trials for Prostate Cancer Metastatic

Trial Evaluating the Safety of 2 Schedules of Cabazitaxel in Elderly Men With mCRPC Previously Treated With a Docetaxel

CABASTY
Start date: May 5, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the incidence of grade ≥ 3 neutropenia and/or neutropenic complications (febrile neutropenia, neutropenic infection) with two schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (≥ 65 years) with mCRPC previously treated with a docetaxel-containing regimen.

NCT ID: NCT02933801 Terminated - Prostate Cancer Clinical Trials

ODM-201 Maintenance Therapy in Patients With mCRPC Previously Treated With Novel Hormonal Agents.

Start date: March 31, 2017
Phase: Phase 2
Study type: Interventional

The main objective of the trial is to assess impact of maintenance therapy with ODM-201 on radiographic progression-free survival (rPFS) of patients with mCRPC pretreated with novel hormonal agents who have non-progressive disease after chemotherapy with a taxane.

NCT ID: NCT02913196 Active, not recruiting - Clinical trials for Prostate Cancer Metastatic

Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With mCRPC

Start date: December 30, 2016
Phase: Phase 1
Study type: Interventional

This is a multi-center, Phase I study of apalutamide in combination with abiraterone acetate, docetaxel and prednisone in patients with metastatic mastrate resistant prostate cancer (mCRPC). This study is designed to determine the dose that apalutamide can be administered safely in combination with abiraterone acetate, docetaxel and prednisone.

NCT ID: NCT02825628 Active, not recruiting - Clinical trials for Prostate Cancer Metastatic

Study of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC)

CRPC
Start date: May 2016
Phase: Phase 2
Study type: Interventional

This is a phase II randomised, double-blind, dose finding, repeat dose Phase II multicentre study of ODX for the treatment of patients with castration resistant prostate cancer (CRPC) and skeletal metastases. The primary objective is to evaluate the relative change from baseline in response markers related to bone metabolism (alkaline phosphatase (B-ALP) and S P1NP) at 12 weeks of three different doses of ODX (3.0, 6.0 and 9.0 mg/kg ODX).

NCT ID: NCT02815033 Completed - Clinical trials for Prostate Cancer Metastatic

Imaging Staging and Response Prediction in Metastatic Hormono-Sensitive Prostate Cancer Patients Receiving Enzalutamide

Start date: July 2015
Phase: Phase 2
Study type: Interventional

The aim of the study is to assess the clinical utility of 11C or 18F-Choline Positron Emission Tomography (PET)/Computed Tomography (CT) scan, Whole Body Magnetic Resonance Imaging (MRI) versus conventional bone scan and prostate-specific antigen (PSA) measurements in response prediction to treatment with Enzalutamide in Hormono-Sensitive Metastatic Prostate Cancer patients. The study will assess how these 2 imaging modalities perform compared to traditional serial PSA measurements and bone scan in assessing metastatic tumour load, progressive disease and response to treatment with Enzalutamide. In addition measurements of serially collected circulating tumour cell (CTC) samples, cell-free tumour DNA and RNA will be performed in order to evaluate their predictive value in terms of response measurement.

NCT ID: NCT02814968 Completed - Clinical trials for Prostate Cancer Metastatic

PET/CT and WB MRI for Staging and Response in CRPC Patients Receiving Enzalutamide

Start date: February 2015
Phase: Phase 2
Study type: Interventional

The aim of the study is to assess the clinical utility of 18F-fluoro-deoxyglucose Positron Emission Tomography (PET)/Computed Tomography (CT) and Whole Body Magnetic Resonance Imaging (MRI) versus conventional bone scan and prostate-specific antigen (PSA) measurements in response prediction to treatment with Enzalutamide in castration-resistant prostate cancer patients. The study will assess how these 2 imaging modalities perform compared to traditional serial PSA measurements and bone scan in assessing metastatic tumour load, progressive disease and response to treatment with Enzalutamide in castration-resistant prostate cancer patients. In addition measurements of serially collected circulating tumour cell (CTC) samples, cell-free tumour DNA and RNA will be performed in order to evaluate their predictive value in terms of response measurement.

NCT ID: NCT02485691 Completed - Clinical trials for Prostate Cancer Metastatic

Cabazitaxel Versus the Switch to Alternative AR-targeted Agent (Enzalutamide or Abiraterone) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent

CARD
Start date: November 9, 2015
Phase: Phase 4
Study type: Interventional

Primary Objective: To compare the radiographic progression-free survival (rPFS) (using Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 for tumor lesions and Prostate Cancer Working Group 2 (PCWG2) criteria for bone scan lesions or death due to any cause) with chemotherapy (cabazitaxel plus prednisone, Arm A) versus Androgen Receptor (AR)-targeted therapy (enzalutamide or abiraterone acetate plus prednisone, Arm B) in mCRPC participants who have been treated with docetaxel and who had disease progression while receiving AR-targeted therapy within 12 months of AR treatment initiation (less than or equal to [<=]12 months, either before or after docetaxel). Secondary Objective: - To compare efficacy for: - Prostate-specific antigen (PSA) response rate and time to PSA progression (TTPP). - Progression-free survival (PFS). - Overall survival (OS). - Tumor response rate and duration of tumor response. - Pain response and time to pain progression. - Symptomatic skeletal event (SSE) rate and time to occurrence of any SSE. - Health status and Health-related Quality of Life (HRQOL). - To evaluate the correlation of a signature of resistance to AR-targeted agents with clinical outcome via the analysis of circulating tumor cell (CTC) phenotypes as well as expression and localization of proteins including AR isoforms in CTCs. - To evaluate safety in the 2 treatment arms.