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A Phase 1 Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT04898634

Population:

Adult

Phase:

I

You are being invited to take part in a research study that includes studying JNJ-78278343 in subjects with prostate cancer. This is an investigational drug which means that this is a new approach for the treatment of people who have prostate cancer. The main purpose of this study is to find a safe dose of JNJ- 78278343 that can be used in the treatment of prostate cancer. To do this, we must find out if JNJ-78278343 can cause side-effects. Also, we need to find out how long JNJ-78278343 stays in and acts on your body and how your body responds to it. Prostate cancer is known to have high...
A Phase 2 Study of Neoadjuvant PARP Inhibition followed by Radical Prostatectomy in Patientswith Unfavorable Intermediate-Risk or High-Risk Prostate Cancer with BRCA1/2 GeneAlterations (NePtune)

Principal Investigator:

Karie Danielle Keera Runcie, MD

Contact Number:

212-342-5162

NCT Number:

NCT05498272

Population:

Adult

Phase:

II

This is a research study to find out if giving a drug called olaparib with a Luteinizing hormone- releasing hormone (LHRH) agonist (medication that suppresses testosterone) before you undergo a radical prostatectomy (surgery to remove your prostate) decreases the amount of cancer present at the time of surgery and decrease the risk of the disease coming back after surgery. You will receive one of the LHRH agonist: leuprolide, triptorelin or goserelin. Olaparib, leuprolide, triptorelin and goserelin is FDA approved for several types of cancers such as certain types of ovarian, breast,...
NRG-GU009: PARALLEL PHASE III RANDOMIZED TRIALS FOR HIGHRISK PROSTATE CANCER EVALUATING DE-INTENSIFICATION FORLOWER GENOMIC RISK AND INTENSIFICATION OF CONCURRENTTHERAPY FOR HIGHER GENOMIC RISK WITH RADIATION(PREDICT-RT*)

Principal Investigator:

Israel Deutsch, MD

Contact Number:

212-342-5162

NCT Number:

NCT04513717

Population:

Adult

Phase:

III

This study is being done in subjects that have high-risk prostate cancer, a low gene risk score and with a plan to receive radiation therapy to find out if: - A shorter hormone therapy treatment is as effective at controlling the prostate cancer compared to the usual 24-month hormone therapy treatment, or - If adding a new hormone therapy drug to the usual treatment increase the length of time without prostate cancer spreading as compared to the usual treatment. Depending on the group you are randomized to you could receive FDA-approved hormone therapy that you and your study doctor will...
Whole-Food Plant-Based Diet (WFPBD) to Control Weight and Metabo-Inflammation in Overweight/Obese Men with Prostate Cancer Receiving Androgen Deprivation Therapy (ADT): A Multi-Center Randomized Control Trial

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT05471414

Population:

Adult

Phase:

NA

The purpose of this study is to assess the efficacy of a home-delivered whole-food plant- based diet (WFPBD) intervention in promoting weight loss in overweight or obese men with prostate cancer receiving androgen deprivation therapy (ADT), as compared to general nutritional counseling only. Another purpose is to assess how easy or difficult it is for patients to comply with a whole-foods plant-based diet, first when it is delivered to their home and later when they have to prepare it on their own. This trial will test whether an intervention such as a special diet is feasible, i.e., whether...
A PHASE 1, MULTI-CENTER, OPEN-LABEL,DOSE-FINDING STUDY TO EVALUATE THE SAFETY,TOLERABILITY, PHARMACOKINETICS, ANDPHARMACODYNAMICS OF CC-94676 IN SUBJECTSWITH METASTATIC CASTRATION-RESISTANTPROSTATE CANCER

Principal Investigator:

Karie Danielle Keera Runcie, MD

Contact Number:

212-342-5162

NCT Number:

NCT04428788

Population:

Adult

Phase:

I

You are being asked to take part in this study because you have been diagnosed with advanced prostate cancer and the standard drugs to treat your disease (metastatic castration-resistant prostate cancer [mCRPC]) are no longer effective or no effective treatment is known for your type of cancer. This research study will test an investigational drug called CC-94676 (the study drug; also known as BMS-986365). Investigational means the study drug being tested has not been approved by the United States Food and Drug Administration (FDA). CC-94676 is a new experimental drug developed by the sponsor...
A Phase 2 Multiple Dose, Multiple-Arm, Parallel Assignment Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of XmAb®20717 Alone or in Combination with Chemotherapy or Targeted Therapies in Selected Subjects with Metastatic

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT05005728

Population:

Adult

Phase:

II

the purpose of this research study is to determine the safety and tolerability of XmAb20717 by itself and in combination with other anticancer therapies (Olaparib, Cabazitaxel, Docetaxel and Carboplatin). XmAb20717 has not been studied in a significant number of humans, therefore, some of its effects are unknown. XmAb20717 is an investigational antibody drug. An antibody is a kind of protein that your body makes to help fight infections. AmAb20717 is an investigational drug in this study because it has not been approved by the U.S. Food and Drug Administration (FDA), the health authority that...
Audiovisual Didactic Experience for Latino patient treatment Adherence and Non-English speaker Trial Enrollment (ADELANTE) Study in Radiation Oncology

Principal Investigator:

Lisa Ann Kachnic, MD, FASTRO

Contact Number:

212-342-5162

NCT Number:

NCT05351424

Population:

Adult

Phase:

II

In this study, you will be randomized to receive either a brochure or watch a video that discusses radiation and cancer clinical trials. In addition, you will complete questionnaires at seven time points: 1 questionnaire before radiotherapy, 4 questionnaires during the course of radiotherapy and 2 questionnaires at follow-up visits. The questionnaires and brochure or video administration will take place during your standard of care visits. Are you Eligible? (Inclusion Criteria) To be included in the main study, you must: 1. be age 18 years or older 2. be Spanish speaker of Latino Background...
A Phase 1/Phase 2 Trial to Evaluate Safety, Immunogenicity and PSA Response of VTP-850 Prostate Cancer Immunotherapeutic in Men with Biochemical Recurrence after Definitive Local Therapy for Prostate Cancer

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT05617040

Population:

Adult

Phase:

I/II

The purpose of this study is to determine how safe the study drug, VTP-850, is in people with prostate cancer who have had initial treatment but their prostate-specific antigen (PSA) levels have started to rise again. This study also aims to find the appropriate dose regimen of VTP-850 that can be given safely to people with prostate cancer. In addition, we want to see if VTP-850 brings about an immune response and if it has an effect on prostate cancer. VTP-850 is considered immunotherapeutic investigative drug, which means that it is meant to work by stimulating a person’s immune...
A Phase 1/2 Study of ONCT-534 in Subjects with Metastatic Castration-Resistant Prostate Cancer

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT05917470

Population:

Adult

Phase:

I/II

The main purpose of this study is to see if ONCT-534 is safe and useful for treating people with R/R mCRPC, when other treatments are not working. ONCT-534 has not been approved by the Food and Drug Administration (FDA). This is a first in human study. We will ask you to have blood drawn, biopsy, physical exam, and tumor imaging such as CT scan, MRI, and bone scan. You may be in this study up to 2 years. Are you Eligible? (Inclusion Criteria) Must be 18 years old or older - No history of seizure disorder(s) - No major surgery within 30 days prior to start of study drug
A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined with JNJ 78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT06095089

Population:

Adult

Phase:

I

The purpose of this study is to find out the side effects of JNJ-87189401 given in combination with JNJ-78278343 to patients with metastatic castration-resistant prostate cancer, and to find which doses of the two study drugs when given in combination cause the least side effects. The study will also look at how long JNJ-87189401 and JNJ-78278343 stay in the body, how they act on the body, and how the body responds to them. JNJ-87189401 and JNJ-78278343 have not been approved by the Food and Drug Administration (FDA). This is the first time that JNJ-87189401 will be used in people. JNJ-...

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