105 results
To evaluate the incidence of grade * 3 neutropenia (measured at Day 7 and Day 14) and/or neutropenic complications (febrile neutropenia, neutropenic infection) with two schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in…
To assess toxicity of MRI-guided focal salvage high-dose-rate brachytherapy (HDR-BT) in patients with locally recurrent prostate cancer. Secondary objectives are quality of life, biochemical disease free survival, dose restrictions, technical…
The objective of this trial is to compare standard treatment with radium-223-chloride (proven surivval benefit) with treatment with rhenium-188-HEDP, which is nowadays only used for pain palliation. This trial includes patients with metastatic…
This study has been transitioned to CTIS with ID 2023-508606-26-00 check the CTIS register for the current data. Primary Objective:The primary objective is to compare the radiographic progression-free survival (rPFS) ofapalutamide in combination…
To assess the effects of testosterone replacement therapy on fat mass and other components of the metabolic syndrome.
The aim of the present phase II Hypo-FLAME 2.0 study is to investigate whether it is feasible and safe (acceptable acute toxicity) to further reduce the Overall Treatment Time of whole gland SBRT with a simultaneous integrated focal boost for…
To determine the influence of darolutamide on the pharmacokinetics of cabazitaxel compared to cabazitaxel alone in mCRPC patients.
1. To compare pembrolizumab plus enzalutamide plus ADT versus placebo plus enzalutamide plus ADT with respect to radiographic progression free survival (rPFS)2. To compare pembrolizumab plus enzalutamide plus ADT versus placebp plus enzalutamide…
To set up a cohort that will serve as a multi-trial platform and facilitate evaluation of new interventional treatment for prostate cancer.
To assess toxicity of MRI guided high-dose-rate focal brachytherapy as monotherapy for favourable risk prostate cancer. As secondary objectives, technical feasibility, quality of life and biochemical free survival will be determined.
The primary aim of this trial is to determine the recommended safe dose and schedule of ModraDoc006/r in castration-resistant prostate cancer (CRPC) patients. The first 5 CRPC patients in this study showed a different pharmacokinetic profile, as…
Primary • To determine the efficacy of enzalutamide compared with placebo as assessed by metastasis-free survival (MFS). Secondary: • To evaluate the benefit of enzalutamide compared with placebo as measured by the following:- Time to PSA…
Part A: healthy volunteers (n=up to 15)Primary/safety objective: - To assess the safety, tolerability and pharmacokinetics of a single IV dosage of OTL78 Secondary objective: - To assess the pharmacodynamics of OTL78 by measuring the temporal…
To compare the oncologic outcomes of PCa patients with an estimated risk of lymph node invasion of 5-20% according to the Briganti nomogram without metastases on PSMA PET/CT undergoing a radical prostatectomy (RP) with or without an ePLND.
The objective of this study is to collect data on treatment outcomes when treating mCRPC using Lu-PSMA. In addition to this, the study aims to identify correlations between biomarkers (ctDNA and CTC*s) and dosimetry data with treatment outcomes of…
This study has been transitioned to CTIS with ID 2024-511537-35-00 check the CTIS register for the current data. Phase 1• To establish the RP2D regimen by evaluation of the safety and tolerability of intravenous (IV) administration of Lutetium (…
The objective of the trial is to determine safety, tolerability and efficacy of VPM1002BC, in order to establish this medication as a therapy for non-muscle invasive bladder cancer in the future.
Primary objective:To determine the equivalent dose of abiraterone when taken with a continental breakfast compared to 1000 mg in fasted stateSecondary objective:To evaluate the preference of the patients: intake of abiraterone with or without food
Main:Overall survivalSecondary:Time to castration resistant prostate cancer Time to initiation of subsequent antineoplastic therapy Symptomatic skeletal event free survival (SSE-FS) Time to first symptomatic skeletal event (SSE) Time to initiation…
To determine the tolerability, pharmacokinetics and pharmacodynamics of liposomal dexamethasone (Oncocort*) in patients with metastatic prostate cancer.