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Phase III study of [18F]PSMA-1007 positron emission tomography for the detection of prostate cancer lesions in patients with biochemical recurrence after previous definitive treatment for localized prostate cancer

There are two co-primary study objectives:• Region-level positive predictive value (PPV) defined as the percentage of all PET-positive regions containing at least one true positive lesion (exactly localized correspondence between [18F]PSMA-1007 PET…

Standard moderately hypofractionated radiotherapy vs. ultra-hypofractionated focal lesion ablative microboost in prostate cancer, Hypo-FLAME 3.0

To demonstrate superiority of whole gland SBRT with a simultaneous integrated focal boost 35/50 Gy in 5 fractions (Hypo-FLAME) regarding 5-year bDFS compared to the current standard moderately hypofractionated schedule of 62 Gy in 20 fractions of 3.…

Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

This study has been transitioned to CTIS with ID 2024-513867-19-00 check the CTIS register for the current data. Primary objective:Compare overall survival for subjects treated with docetaxel versus subjects treated with docetaxel plus raduim-…

A phase III randomized, double-blind, placebo-controlled trial of radium-223 dichloride in combination with abiraterone acetate and prednisone/prednisolone in the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve subjects with bone predominant metastatic castration-resistant prostate cancer (CRPC)

to provide access to Radium-223 dichloride together with abiraterone and prednisone to patients diagnosed with CRPC with bonemetasasis.

A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus
Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men
With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive
Therapy.

This study has been transitioned to CTIS with ID 2024-513521-23-00 check the CTIS register for the current data. All efficacy and safety objectives will compare enzalutamide plus leuprolide and enzalutamide monotherapyversus placebo plus leuprolide.

Effectiveness of focal therapy in men with prostate cancer (ENFORCE)

We hypothesize that a significant proportion of the patients will benefit more from focal therapy as compared to usual care in terms of morbidity and quality of life, without compromising oncological effectiveness. Primary objective: To study the…

IVD1: Clinical Performance Study Plan For The Use of Myriad MyChoice® For Patient Enrolment Into the AZD5305 (Saruparib) vs Placebo in Participants with Metastatic Castration-Sensitive Prostate Cancer Receiving Physician*s Choice New Hormonal Agents;IVD2: Clinical Performance Study Plan for F1LCDx Used in Clinical Trial EvoPAR-Prostate01 ;Main: A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of AZD5305 in Combination with Physician*s Choice New Hormonal Agents in Patien

IVD1: The primary objective of this clinical performance study is to evaluate the effectiveness of the MyChoice® test in identifying HRRm or non-HRRm mCSPC patients as part of the enrolment criteria for EvoPAR-prostate01. This clinical performance…

PROCADE: A Multinational Phase 3, Randomized, Double-Blind, Non-Inferiority, Efficacy and Safety Study of Oral HC-1119 versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Primary Objective:• To determine the efficacy of HC-1119 as compared to enzalutamide as assessed by overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) until 24 weeks.Key Secondary Objective:• To…

An open-label, single arm, roll-over study to provide continued treatment with darolutamide in participants who were enrolled in previous Bayer-sponsored studies

This study has been transitioned to CTIS with ID 2022-502084-38-00 check the CTIS register for the current data. Primary- Continuation of treatment- SafetySecondairy- Documentation of tolerability

An open-label, multicentre, single arm study to assess the efficacy and safety of triptorelin 6-month formulation administered subcutaneously in participants with locally advanced and/or metastatic prostate cancer previously treated and castrated with a GnRH analogue

To evaluate the efficacy of triptorelin embonate 22.5 mg 6-month formulation administered subcutaneously in maintaining serum testosterone castrate levels in participants with advanced prostate cancer previously treated and castrated with a GnRH…

ARCHES:A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

Primary Objective- To determine the benefit of enzalutamide plus ADT as compared to placebo plus ADT as assessed by radiographic progression-free survival (rPFS) based on central reviewMain Secondary Objectives- To determine the benefit of…

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…

Randomized multicenter, phase III trial evaluating the safety of 2 schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (* 65 years) with metastatic castration-resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen (CABASTY).

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…

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…

A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)

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…

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 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…

Prostate Cancer Imaging with [18Flourine]Prostate Specific Membrane Antigen (PSMA) PET: a study on pharmacokinetics and test repeatability

The present study aims to:A) acquire a pharmacokinetic model of [18F]PSMA ([18F]-DCFPyl), by which simplified methods to quantify [18F]PSMA PET signal will be validated ; andB) assess the repeatability of those simplified quantitative method.

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…