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Determining the clinical relevance of the interaction between enzalutamide and the opioid morphine and the DOAC edoxaban to improve rational pharmacological care of patients with prostate cancer

This study has been transitioned to CTIS with ID 2024-517646-34-00 check the CTIS register for the current data. The objective of this study is to evaluate the effect of enzalutamide on morphine and edoxaban pharmacokinetics. This information is…

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ56021927 in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment with Primary Radiation Therapy

Primary ObjectiveTo determine if JNJ-56021927 plus gonadotropin releasing hormone (GnRH) agonist in subjects with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT) results in an improvement of…

A Phase 3, Randomized Open-label Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Participants with Metastatic Castration resistant Prostate Cancer (mCRPC) Who are Unselected for Homologous Recombination Repair Defects and Have Failed Prior Treatment with One Next-generation Hormonal Agent (NHA) and Chemotherapy (KEYLYNK-010)

1) To compare pembrolizumab plus olaparib to abiraterone acetate or enzalutamide with respect to overall survival (OS)2) To compare pembrolizumab plus olaparib to abiraterone acetate or enzalutamide with respect to radiographic progression-free…

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Who are Candidates for Radical Prostatectomy

This study has been transitioned to CTIS with ID 2023-506153-38-00 check the CTIS register for the current data. The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical…

Testosterone based dosing regimen of goserelin in patients with prostate cancer

The primary objective is to determine in which percentage of patients with prostate cancer with an indication for ADT, it is safe to extend the dosing interval of goserelin 10,8 mg by four weeks, before the 4th injection, using a testosterone based…

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer

This study has been transitioned to CTIS with ID 2023-509221-47-00 check the CTIS register for the current data. To demonstrate superiority in the metastasis-free survival (MFS) of men with high risk NM-CRPC treated with apalutamide versus…

Individualisation of management with novel upfront therapies in newly diagnosed metastasized prostate cancer using (PSMA)PET/CT imaging

To assess the predictive value of early response measurements on PSMA-PET/CT for therapy success, defined as time to development of castration-resistant prostate cancer (CRPC), in order to personalize treatment choice.

Individualisation of management with novel upfront therapy enzalutamide in newly diagnosed metastasized prostate cancer using (PSMA)PET/CT imaging

To assess the predictive value of early response measurements on PSMA-PET/CT for therapy success, defined as time to development of castration-resistant prostate cancer (CRPC), in order to personalize treatment choice.

Pharmacokinetics of the CYP3A substrate Midazolam after steady-state dosing of IMU-935.

In this study, we will evaluate a possible interaction between IMU-935 and midazolam. We will do this by investigating the effect of IMU-935 on how quickly and to what extent midazolam is absorbed, transported, and eliminated from the body. In…

HYPo-fractionated Radiotherapy of Lymph Node Metastases guided by NanO-MRI in Prostate Cancer Patients: A Pilot Study (HYPNO-study)

To evaluate the feasibility and efficacy of MR-guided stereotactic body radiotherapy (SBRT) to nano-MRI detected regional lymph node metastases in patients with biochemical recurrent prostate cancer after radical prostatectomy.

PRostatE Cancer MRI guided focal SalvagE high-dose-rate brachytherapy

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…

An Open-label, Multicenter, Phase 1b Study of JNJ-63723283, a PD-1 Inhibitor, Administered in Combination with Apalutamide in Subjects with Metastatic Castration- Resistant Prostate Cancer

Primary objectives:# To evaluate the safety of the combination of JNJ-63723283 with apalutamide.# To define a population of subjects with metastatic CRPC who respond to treatment with the combination of JNJ-63723283 and apalutamide.Secondary…

Does stimulation of salivary glands by oral intake increase uptake and toxicity of PSMA-ligands?

To determine if stimulated salivation during the biodistribution of PSMA-ligands causes a significant increase in the accumulation in salivary glands

PSMA-PET/CT imaging in the EArly detection of Cancer of the Prostate with High Risk Features

To assess whether PSMA-PET/CT imaging can be used as a tool to select men for prostate biopsy, or otherwise is able to reduce the number of bothersome biopsy cores in those with an increased risk of aggressive prostate cancer*

A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Plus ADT Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (KEYNOTE-991)

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…

EREctile Conservation after prostate radiation Therapy (ERECT);
a prospective phase 2 trial

Investigation of maintenance of erectile function after MR-guided radiotherapy with neurovascular sparing in patients with localized prostate cancer.

A Randomized, Double-Blind, Placebo-Controlled, Phase IIIb Study of the Efficacy and Safety of Continuing Enzalutamide in Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer Patients Treated with Docetaxel plus Prednisolone Who Have Progressed on Enzalutamide Alone.

The primary objective of this research is to compare the efficacy of continuing treatment with enzalutamide after adding docetaxel and prednisolone versus placebo plus docetaxel and prednisolone, as measured by progression-free survival (PFS) in…

In-vivo focal prostate imaging with confocal laser endomicroscopy and optical coherence tomography

Objective procedure 1:To assess the technical feasibility and safety of in-vivo focal imaging with CLE and OCT.Objective procedure 2: Primary Objective: To identify and define characteristics of prostate cancer on CLE and OCT and compare this with…

Prostate cancer Immune profiling before, during and after HDR-brachytherapy in local relapsed prostate cancer.

To investigate that low-dose HDR-brachytherapy of prostate cancer will make from an immunologically *cold* (no T-cell infiltrations) prostate cancer an immunologically *hot* (CD4 and CD8-cell infiltrations) tumor.

Prospective Randomized Controlled Trial To Evaluate The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy (PREDICT-Study)

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.