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Evaluation of 18F-FDHT PET/CT as a predictor of response in patients with metastasized castration-resistant prostate cancer to be treated with enzalutamide.

Primary objective: to explore 18F-FDHT PET/CT as a predictor of response in patients with metastasized CRPC to be treated with enzalutamide. Secondary objective: to explore 18F-FDHT PET/CT as a predictor of clinical survival endpoints in patients…

An Exploratory Phase 2, open-label, single-arm, efficacy and imaging Study of Oral Enzalutamide (MDV3100) Androgen Receptor (AR)-Directed Therapy in Chemo-Naïve patients with Progressive Prostate Cancer who have failed Androgen Deprivation Therapy (CRPC patients)

1. To evaluate the feasibility of 18F-FDG PET/CT, or WB MRI or both to determine metastatic tumour load before and after treatment with Enzalutamide in CRPC patients. 2. To evaluate how these 2 imaging modalities perform compared to traditional…

Personalizing enzalutamide (Xtandi®) therapy by understanding the relation between the decrease in the expression profile of a panel of preselected microRNAs, tumor related mRNAs and treatment response in patients with mCRPC (ILUMINATE)

Primary Objectives:To explore whether the decrease in a panel of early easily assessable biomarkers (PSA-mRNA, PCA3-mRNA and TMPRSS2:ERG gene fusion-mRNA, (currently under development) ARv7 mRNA, ARwt mRNA, miR-21, miR-141, miR-200a, miRrumc95,…

Dynamics of Androgen Receptor genomics and transcriptomics after neoadjuvant androgen ablation (DARANA)

1. To assess the effects of 3 months neoadjuvant androgen ablation with enzalutamide on the surgicial margin status of men with non-metastasized prostate cancer.2. To properly evaluate the effects of androgen ablation on gene expression, analyses of…

Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic
Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)

This study has been transitioned to CTIS with ID 2023-506987-15-00 check the CTIS register for the current data. 1) Objective: To evaluate the safety and tolerability of the pembrolizumab combination therapy.2) Objective: To estimate PSA response…

An Exploratory Phase 2, open-label, single-arm, efficacy and imaging Study of Oral Enzalutamide (MDV3100) Androgen Receptor (AR)-Directed Therapy in Hormono-Sensitive patients with Metastatic Prostate Cancer.

1. To evaluate the feasibility of 18F-FDG PET/CT, or WB MRI or both to determine metastatic tumour load before and after treatmentwith Enzalutamide in patients with metastatic prostate cancer.2. To evaluate how these 2 imaging modalities perform…

An open-label Phase I/IIa study to evaluate the safety and efficacy of CCS1477 as monotherapy and in combination, in patients with advanced solid/metastatic tumours.

Primary objective To investigate the safety and tolerability of CCS1477 as monotherapy and in combination.

A randomized, open label, Phase IIB trial of Optimal Sequencing of Treatment Options for Poor Risk Metastasized Castration Resistant Prostate Cancer Previously Treated with Docetaxel (OSTRICh trial)

Primary: * To assess Clinical Benefit Rate (CBR) in patients with mCRPC and poor prognostic factors treated with cabazitaxel or novel hormonal agents (abiraterone OR enzalutamide) as second-line therapy.Secondary: * To formally compare CBR in both…