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TALAPRO-3: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, STUDY OF TALAZOPARIB WITH ENZALUTAMIDE VERSUS PLACEBO WITH ENZALUTAMIDE IN MEN WITH DDR GENE MUTATED METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER

This study has been transitioned to CTIS with ID 2024-510809-28-00 check the CTIS register for the current data. Primary objectiveTo demonstrate that talazoparib in combination with enzalutamide is superior to placebo in combination with…

Repeated Rhenium-188-HEDP versus Radium-223-chloride in patients with metastatic castration-resistant prostate cancer: the RARE study.

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…

PROSPEC study; PROstate cancer follow-up care in Secondary and Primary hEalth Care

We hypothesize that the follow-up and aftercare of prostate cancer in the Netherlands can be led by the GP. We hypothesize that GP-led recurrence detection programme leads to at least equal detection of recurrences as the current follow-up in…

Short-term Testosterone replacement in testicular cancer survivors to treat overweight and improve cardiometabolic risk: a pilot study

To assess the effects of testosterone replacement therapy on fat mass and other components of the metabolic syndrome.

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…

A Multinational, Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer

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…

A phase 1a/1b/2 study to assess the safety, tolerability and pharmacokinetics of OTL78, a PSMA-targeted fluorescent agent, for the intraoperative imaging of prostate cancer

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…

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.

A randomized, double-blind, placebo controlled Phase III study of ODM-201 versus placebo in addition to standard androgen deprivation therapy and docetaxel in patients with metastatic hormone sensitive prostate cancer

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…

Less injections by androgen scrutinisation

The primary objective of this study is to determine the possibility to extend the dosing interval of goserelin 10.8 mg with a testosterone-based dosing regimen compared to regular treatment with 3-monthly based goserelin 10.8 mg injections. This…

Prospective randomized multicenter comparison of indocyanine green (ICG)-99mTc-nanocolloid vs. 99mTc-nanocolloid plus an intraoperative injection of ICG for the detection and surgical resection of the sentinel nodes in patients with prostate cancer

Primary Objective(s): 1. Number of positive patients (as determined following histopathological analysis of the excised nodes).Secondary Objective(s): Collection of the below summarized information will provide us an answer to the following…

A PHASE Ib/II STUDY OF IPATASERTIB (GDC-0068) OR APITILISIB (GDC-0980) WITH ABIRATERONE ACETATE VERSUS ABIRATERONE ACETATE IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER PREVIOUSLY TREATED WITH DOCETAXEL-BASED CHEMOTHERAPY

PHASE IIPrimary ObjectiveThe primary objective of the Phase II portion of the study is to estimate the efficacy as measured by radiographic progression-free survival of IPATASERTIB (GDC-0068) (dosed at either 400 mg or 200 mg daily) + abiraterone…

A Randomized, Double Blind, Multicenter, Parallel-group, Phase III study to evaluate efficacy and safety of DCVAC/PCa versus Placebo in Men with metastatic Castration Resistant Prostate Cancer eligible for 1st line chemotherapy

The primary objective is to show superiority of treatment with DCVAC/PCa in addition to Standard of Care chemotherapy (docetaxel plus prednisone) over placebo in addition to Standard of Care chemotherapy (docetaxel plus prednisone) in men with mCRPC…