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Phase 1, Dose-Escalation Study of KTX-2001 (an NSD2 Inhibitor)Alone and in Combination with Darolutamide for MetastaticCastration-Resistant Prostate Cancer

Principal Investigator:

Alexander Z. Wei, MD

Contact Number:

212-342-5162

NCT Number:

NCT07103018

Population:

Adult

Phase:

I

KTX-2001 is effective for the treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC). The study drug KTX-2001 has been tested in animals but not yet in people, and it is experimental, which means it is not approved by the United States Food and Drug Administration (FDA). The study drug KTX-2001 is similar to another drug, KTX-1001, that has been tested in people with multiple myeloma, a blood cancer, except for a small change in its chemical makeup which may improve the features of the drug. Darolutamide is a drug that is FDA approved for people with non-metastatic castration-...
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,...
Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification And Intensification Clinical Trial Evaluation (GUIDANCE)

Principal Investigator:

Israel Deutsch, MD

Contact Number:

212-342-5162

NCT Number:

NCT05050084

Population:

Adult

Phase:

III

This study is being done to answer the following questions: If a patient has unfavorable intermediate risk prostate cancer, a low gene risk score and plans to receive radiation therapy with hormone therapy, is radiation therapy alone as effective at controlling the cancer compared to the usual combination of radiation and hormone therapy? If a patient has unfavorable intermediate risk prostate cancer, a higher gene risk score and plans to receive radiation therapy with hormone therapy, does adding another new hormone therapy drug to the usual combination of radiation and hormone therapy...
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...
A Phase 1b/2 Study Evaluating the Activity of Tinengotinib (TT–00420) in Combination with Androgen Receptor Signaling Inhibitors (ARSIs) in Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC)

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT06457919

Population:

Adult

Phase:

I/II

You are being asked to take part in this study because you have a type of prostate cancer called metastatic castration-resistant prostate cancer (mCRPC), meaning that your disease has spread to other parts of your body (metastatic). The purpose of this study is to determine whether adding the experimental drug tinengotinib, which is not yet approved by the United States Food and Drug Administration (FDA), to your standard treatment is safe, effective, and produces minimal or mild side effects in individuals with mCRPC. Additionally, we will evaluate the effectiveness of tinengotinib in...
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...
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 1b Platform Study to Evaluate JNJ-78278343-based Therapeutic Combinations for Advanced Prostate Cancer

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT07082920

Population:

Adult

Phase:

I

The purpose of this study is to find a safe dose of investigational study drug, JNJ- 95298177 when given in combination with investigational drug, JNJ-78278343 in patients with prostate cancer. JNJ-78278343 and JNJ-95298177 are not approved by the United States Food and Drug Administration (FDA). The sponsor, Janssen Research & Development, provides the investigational study treatment, called “JNJ-78278343 and JNJ-95298177”. This is the first time that JNJ-78278343 is being used in combination with JNJ-95298177. Are you Eligible? (Inclusion Criteria) At the time of informed...
Phase I/II trial of pembrolizumab and androgen-receptor pathway inhibitor with or without 225Ac-J591 for progressive metastatic castration resistant prostate cancer

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT04946370

Population:

Adult

Phase:

I/II

The main purpose of this study is to evaluate the maximum tolerated and recommended dose of pembrolizumab and an androgen-receptor pathway inhibitor with or without 225Ac-J591, to see what the side effects are and if they work for metastatic castration resistant prostate cancer. Pembrolizumab may help the body’s immune system fight tumor cells. It does this by keeping certain blood cells, called T cells, active so they can attack the cancer. T-cells are also part of your immune system. Thousands of patients have received pembrolizumab, but it is not approved for most patients with...
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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