Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

1. MR-targeted biopsy using Artemis device fusion of MRI and ultrasound images would be performed. MR targeted biopsy would be performed by radiologist.
2. Next conventional ultrasound-guided 12-core systematic biopsy would be performed by urologist. This portion will be performed without information of the MRI report.

Before prostate biopsy, all patients be preceded by mpMRI.MR-targeted biopsy using Artemis device fusion of MRI and ultrasound images would be performed. MR targeted biopsy would be performed by radiologist.

Artemia

In Gab Jeong, MD, PhD

In Gab Jeong, MD

In Gab Jeong, MD,PhD

This paired cohort blinded trial aims to assess the detection rate of clinically significant cancer of MRI-targeted biopsy compared to standard 12-core TRUS biopsy in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy. The investigators hypothesize that additional MRI-targeted biopsy will detect more clinically significant cancers than standard TRUS biopsy.

Main objective: To compare MR-target vs. standard 12-cores TRUS-biopsy for the diagnosis of clinically significant prostate cancer.

Before prostate biopsy, all patients be preceded by mpMRI. The mpMRI is read by an experienced radiologist according to the PI-RADS version 2 scoring system. PI-RADS scoring system is used to assign a degree of doubt prostate cancer. Depending on the PI-RADS score, MR targeted biopsy is determined.

1. MR-targeted biopsy using Artemis device fusion of MRI and ultrasound images would be performed. MR targeted biopsy would be performed by radiologist.
2. Next conventional ultrasound-guided 12-core systematic biopsy would be performed by urologist. This portion will be performed without information of the MRI report.

MR-target Biopsy vs. TRUS-biopsy in Men With Suspicious Prostate Cancer

MR-target Biopsy vs. TRUS-biopsy in Men With Suspicious Prostate Cancer: A Paired Cohort Study

Bumjin Lim

Dalsan Yoo

Hyung Keun Park

Jun Hyuk Hong

Hanjong Ahn

Choung-Soo Kim

Kye Jin Park

Mi-Hyun Kim

Jeong Kon Kim

Asan Medical Center

Professor, Department of Urology, Asan Medical Center

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Mesothelioma

Mesothelioma, Malignant

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Malignant Mesothelioma

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Pemetrexed

Cisplatin

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Combination Phase - Amatuximab + Pemetrexed and Cisplatin

Maintenance Phase - Amatuximab

Combination Phase - Placebo + Pemetrexed and Cisplatin

Maintenance Phase - Placebo

Combination Phase - Placebo will be administered IV (intravenous infusion) once weekly for six 21-day cycles.

Maintenance Phase - Placebo will be administered IV (intravenous infusion) once weekly until disease progression.

Placebo

Combination Phase - Amatuximab 5mg/kg will be administered IV (intravenous infusion) once weekly for six 21-day cycles.

Maintenance Phase - Amatuximab 5mg/kg will be administered IV (intravenous infusion) once weekly until disease progression.

Amatuximab

Combination Phase - Pemetrexed 500 mg/m\^2 will be administered IV on Day 1 of each 21-day cycle for 6 cycles.

Combination Phase - Cisplatin 75 mg/m\^2 will be administered IV on Day 1 of each 21-day cycle for 6 cycles.

This study was originally designed as a multicenter, double-blind, randomized, parallel-group study, using a placebo control or amatuximab 5 milligrams per kilogram (mg/kg), administered weekly, designed to evaluate the safety and efficacy of amatuximab in combination with pemetrexed and cisplatin in participants with unresectable Malignant Pleural Mesothelioma (MPM) who have not received prior systemic therapy.

Per a business decision made by the Sponsor, participants who were randomized to amatuximab and were still on active treatment at the time of the protocol amendment may have consented to continue to receive weekly treatment with amatuximab until disease progression or intolerable toxicity at the discretion of the principal investigator. Participants randomized to placebo or who were in follow-up at the time of the amendment have been discontinued from the study.

Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma (MPM)

A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma

AEs included both non-SAEs and SAEs and the same participant can have both SAEs and as well non-SAEs.

Morphotek

Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.

During Combination Treatment Phase, participants received amatuximab 5 mg/kg, infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.

Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin

During Combination Treatment Phase, participants received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.

Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin

Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.

Maintenance Treatment Phase: Amatuximab

Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.

Maintenance Treatment Phase: Placebo

During Combination Treatment Phase, participants received amatuximab 5 mg/kg, infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.

Amatuximab + Pemetrexed + Cisplatin

During Combination Treatment Phase, participants received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.

Placebo + Pemetrexed + Cisplatin

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The safety analysis set was defined as all randomized participants who received at least 1 dose of study drug.

The study was terminated due to business decision. No safety concerns involved in decision to terminate this study.

Eisai Medical Information

SAEs

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

During Combination Treatment Phase, participants received amatuximab 5 milligram per kilogram (mg/kg), infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 milligram per square meter (mg/m\^2) and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
MR-target Biopsy vs. TRUS-biopsy in Men With Suspicious Prostate Cancer	NCT04320147	Prostate Cancer	Artemia	50 Years - 80 Years	Asan Medical Center
Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma (MPM)	NCT02357147	Mesothelioma, M...	Placebo Amatuximab Pemetrexed Cisplatin	18 Years -	Morphotek

Spots Global Cancer Trial Database for artemis

Every month we try and update this database with for artemis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for artemis

Every month we try and update this database with for artemis cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for artemis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.