Clinical Trials

Clinical trials are an important step in discovering new treatments for urologic cancers, and may even have the potential in finding new cures. Here at New Jersey Urology, we have a dedicated research staff and clinical research experts who will assist you through your entire journey.

What are the Benefits of a Clinical Trial?

  • You may get a new treatment for a disease before it is available to everyone.
  • You play a more active role in your own health care.
  • Researchers may provide you with medical care and more frequent health check-ups as part of your treatment.
  • You may have the chance to help others get a better treatment for their health problems in the future.
  • You may be able to get information about support groups and resources.

New Jersey Urology has extensive experience in conducting Phase 1b – IV trials for various urological conditions. Please view our clinical trials below.

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Prostate Cancer Immunotherapies

You may be eligible for New Jersey Urology’s immunotherapy clinical trials now available at our Cherry Hill, Saddle Brook, and West Orange, New Jersey Cancer Treatment Centers.

What is Immunotherapy?
Immunotherapy teaches your body to spot and destroy cancer cells, and may help your immune system long after your treatment ends.

Types of Immunotherapy
Certain types of immunotherapy attack cancer while sparing healthy cells or slow its spread to other parts of the body.

Register now to see if you qualify or call 973-846-7028.

Sponsor / Study Title:

MANA RBM / ESCALATE, A Phase III Randomized Study Comparing Enzalutamide or Darolutamide with Radium-223 vs Enzalutamide or Darolutamide with Placebo and the Effect upon Symptomatic Skeletal Event-Free Survival for mCRPC Patients

Protocol Number: PC18-1005

Principal Investigator: Domenico Savatta, MD, FACS
(Study Doctor)

Telephone: 908-484-6575 (24 Hour)

Address: New Jersey Urology
1515 Broad St
Suite 120
Bloomfield, NJ 07003

Protocol Number: PC18-1005

Principal Investigator: Gordon Brown, MD, FACS
(Study Doctor)

Telephone: 908-484-6575 (24 Hour)

Address: New Jersey Urology
2090 Springdale Road
Suite D
Cherry Hill, NJ 08003

 

You may be eligible for a Phase 3 randomized advanced clinical study for metastatic castration-resistant prostate cancer (mCRPC) patients experiencing bone pain or cancer that has metastacized to the bone. For more information, call us at 908-484-6575.

KEY INFORMATION
You are invited to take part in a research study. This research study is studying Xtandi (enzalutamide) or Nubeqa (darolutamide) followed by Xofigo (radium-223) or Placebo (saltwater) as a possible treatment for metastatic castration-resistant prostate cancer (mCRPC). MANA RBM is sponsoring this research study.

Sponsor / Study Title:

Janssen R&D / A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases

Protocol Number: NCT04523207

Principal Investigator: Gordon Brown, DO
(Study Doctor)

Telephone: (856) 673-1613

Address: New Jersey Urology
2401 Evesham Road, Suite F
Voorhees, NJ 08043

 

You may be eligible for a Phase 2 Prostate Cancer Clinical Trial for non-metastatic prostate cancer and have undergone radical prostatectomy (RP). For more information, call us at 856-873-1613.

KEY INFORMATION
The purpose of this study is to assess if the combination of apalutamide and androgen deprivation therapy (ADT) in participants with high-risk localized prostate cancer improves the biochemical recurrence (BCR) free rate.

Sponsor / Study Title:

Palette Life Sciences / Randomized Trial of Barrigel® to increase distance between the prostate and rectum to decrease rectal dose in patients receiving definitive radiation therapy for localized prostate cancer

Protocol Number: NCT04189913

Principal Investigator: Glen Gejerman, MD
(Study Doctor)

Telephone: (201) 881-1000

Address: New Jersey Urology
160 Pehle Avenue
Suite 103
Saddle Brook, NJ 07663

For more information, call us at 201-881-1000.

Sponsor / Study Title:

Exosome Diagnostics, Inc. / ExoDx Prostate Evaluation in Prior Negative Prostate Biopsy Setting

Protocol Number: NCT04357717

Principal Investigator:
(Study Doctor)

Gordon Brown, DO (Voorhees)
Eric J. Margolis, MD (Englewood)
Karl Coutinho (Millburn)

Multiple Site Locations

Voorhees
2401 Evesham Road, Suite F
Voorhees, NJ 08043
Phone: (856) 673-1613

Englewood
300 Grand Avenue
Englewood, NJ 07631
Phone: (201) 816-1900

Millburn
225 Millburn Avenue
Building C, Suite 304
Millburn, NJ 07041
Phone: (973) 218-9400

The study is designed to confirm the performance of the ExoDx Prostate test in prior negative biopsy patients now presenting for a repeat prostate biopsy.

ClinicalTrials.gov – NCT04357717

Sponsor / Study Title:

Candel Therapeutics, Inc. / Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer (PrTK03)

Protocol Number: NCT01436968

Principal Investigator: Glen Gejerman, MD
(Study Doctor)

Multiple Site Locations

Cherry Hill
2090 Springdale Road
Suite B
Cherry Hill, NJ 08003
Phone: (856) 751-9010

Saddle Brook
160 Pehle Avenue
Suite 103
Saddle Brook, NJ 07663
Phone: (201) 881-1000

West Orange
375 Mount Pleasant Avenue
Suite 251
West Orange, NJ 07052
Phone: (973) 323-1300

The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in combination with radiation therapy for patients with intermediate-high risk localized prostate cancer. ProstAtak kills tumor cells and stimulates a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body’s immune system to detect and destroy cancer cells. ProstAtak has shown synergy with radiation without added toxicity and lower than expected recurrence rates in previous clinical trials. The hypothesis is that ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the ProstAtak or control arm at a 2:1 ratio. Both arms receive standard external beam radiation therapy. Short-term androgen deprivation therapy may be given but is not required.

ClinicalTrials.gov – NCT01436968

Sponsor / Study Title:

Bayer / Study to Compare the Effects of Drug Darolutamide and Drug Enzalutamide on Physical Function, Including Balance and Daily Activity, in Patients With Castration-resistant Prostate Cancer (CRPC) (DaroAcT)

Protocol Number: NCT04157088

Principal Investigator: Gordon Brown, DO
(Study Doctor)

Telephone: (856) 673-1613

Address: New Jersey Urology
2401 Evesham Road, Suite F
Voorhees, NJ 08043

Researchers in this study want to compare the effects of drug darolutamide and drug enzalutamide on physical function, including balance and daily activity, in patients with castration-resistant prostate cancer (CRPC). Both darolutamide and enzalutamide are approved AR inhibitors used for the treatment of patients with CRPC. AR inhibitor is a substance that keeps androgens (male sex hormones) from binding to proteins called androgen receptors, which are found in normal prostate cells, some prostate cancer cells, and in some other cells. Preventing this binding blocks the effects of these hormones in the body and therefore keeps prostate cancer cells from growing. Patients participating this study will receive either darolutamide or enzalutamide tablets. For more information, call us at 856-873-1613.

Sponsor / Study Title:

Bayer / A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat With Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described (DAROL)

Protocol Number: NCT04122976

Principal Investigator: Eric J. Margolis, MD
(Study Doctor)

Telephone: (201) 816-1900

Address:

New Jersey Urology
300 Grand Avenue
Englewood, NJ 07631

The purpose of this study is to find out in the real-world setting, if darolutamide is safe and effective for patients diagnosed with prostate cancer that has not spread to other parts of the body. When a patient is enrolled to the study, his/her physician would have already made the decision to treat patient with darolutamide per local standard practice. For more information, call us at 201-816-1900.

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Sponsor / Study Title:

Merck & Co. / Study of Pembrolizumab (MK-3475) in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057)

Protocol Number: NCT02625961

Principal Investigator: Gordon Brown, DO
(Study Doctor)

Telephone: (856) 673-1613

Address: New Jersey Urology
2401 Evesham Road, Suite F
Voorhees, NJ 08043

In this Phase 2 study, participants with high risk non-muscle-invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) therapy and who are considered ineligible for or have refused to undergo radical cystectomy, will receive pembrolizumab therapy. The primary study hypothesis is that treatment with pembrolizumab will result in a clinically meaningful response. For more information, call us at 856-873-1613.

Sponsor / Study Title:

Bristol-Myers Squibb / A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder (CheckMate 9UT)

Protocol Number: NCT03519256

Principal Investigator: Gordon Brown, DO
(Study Doctor)

Telephone: (856) 673-1613

Address: New Jersey Urology
2401 Evesham Road, Suite F
Voorhees, NJ 08043

A Phase 2 study to evaluate Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer. For more information, call us at 856-873-1613.

Sponsor / Study Title:

UroGen Pharma Ltd. / A Phase 3 Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer (ATLAS)

Protocol Number: NCT04688931

Principal Investigator: Gordon Brown, DO
(Study Doctor)

Telephone: (856) 673-1613

Address: New Jersey Urology
2401 Evesham Road, Suite F
Voorhees, NJ 08043

This is a global, randomized, controlled, open-label Phase 3 study designed to assess the long-term efficacy and safety of UGN-102 (mitomycin) for intravesical solution with or without (±) transurethral resection of bladder tumors (TURBT) versus TURBT alone for the treatment of patients with low grade intermediate risk non-muscle-invasive bladder cancer (LG IR NMIBC). For more information, call us at 856-873-1613.

Sponsor / Study Title:

enGene, Inc. / A Phase 1/2 Study of EG-70 as an Intravesical Administration to Patients with BCG-Unresponsive NMIBC. A novel non-viral gene therapy platform for delivering DNA to mucosal cells and localize expression of immune modulators to the bladder mucosa

Protocol Number: EG70-101

Principal Investigator: Gordon Brown, DO
(Study Doctor)

Telephone: (856) 673-1613

Address: New Jersey Urology
2401 Evesham Road, Suite F
Voorhees, NJ 08043

This open-label, multicenter study will evaluate the safety and efficacy of intravesical administration of EG-70 and its effect on bladder tumors in patients with NMIBC who have failed BCG therapy and are recommended for radical cystectomy. This study consists of two parts, a dose-escalation Phase (Phase 1) to establish safety and recommended phase 2 dose (RP2D), followed by a Phase 2 efficacy study at the RP2D to establish efficacy. For more information, call us at 856-873-1613.

Sponsor / Study Title:

QED Therapeutics, Inc. / Study of Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations

Protocol Number: NCT04197986

Principal Investigator: 
(Study Doctor)

Gordon Brown, DO (Voorhees)
Elan Diamond, MD (Saddle Brook)

Two Locations:

Voorhees
New Jersey Urology
2401 Evesham Road, Suite F
Voorhees, NJ 08043
Phone: (856) 673-1613

Saddle Brook
New Jersey Urology
160 Pehle Avenue
Suite 103
Saddle Brook, NJ 07663
Phone: (201) 881-1000

This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of giving an oral targeted FGFR1-3 inhibitor, infigratinib, as adjuvant treatment following surgery in adult subjects with invasive urothelial carcinoma and susceptible FGFR3 genetic alterations (mutations, and gene fusions or translocations [ie, rearrangements) who have disease that is considered at high risk for recurrence with surgery alone. The study enrolls subjects with either bladder cancer post radical cystectomy or upper tract urothelial cancer post distal ureterectomy and/or nephrectomy. Study treatment is randomized between infigratinib or placebo with treatment until invasive local or distal disease recurrence. For more information, call us at 856-873-1613.

ClinicalTrials.gov – Study: NCT04197986

Sponsor / Study Title:

Urotronic Inc. / A Clinical Study to Evaluate the Safety and Efficacy of the Optilume™ BPH Catheter System in Men With Symptomatic BPH (PINNACLE)

Protocol Number: PR1087

Principal Investigator: Dr. Karl Coutinho
(Study Doctor)


Locations:

Multi-Centers

Pinnacle BPH Clinical Study

About the PINNACLE Study

PINNACLE is a prospective, multi-center, randomized control clinical trial to establish the safety and efficacy of the Optilume™ BPH Catheter System in the treatment of benign prostatic hyperplasia (BPH). The study is enrolling men 50 to 80 that meet selection criteria. All costs are paid by the study.

Take this survey to see if you qualify for a no-cost clinical trial to investigate a new way to relieve your prostate symptoms.

ClinicalTrials.gov – Study: NCT04131907.

Sponsor / Study Title:

Urovant Sciences GmbH / Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)

Protocol Number: URO-901-3005

Principal Investigator: 
(Study Doctor)

Eric J. Margolis, MD (Bloomfield)
Alan Perzin, MD (Mount Laurel)
David Sussman, MD (Voorhees)


Locations:

Bloomfield
1515 Broad Street, Suite 120
Bloomfield, NJ 07003
Phone: (833) 876-8268

Mount Laurel
15000 Midlantic Drive, Suite 100
Mount Laurel, NJ 08054
Phone: (856) 840-4563

Voorhees
2401 Evesham Road, Suite F
Voorhees, NJ 08043
Phone: (856) 673-1613

Courage Study for men on BPH therapy experiencing OAB symptoms

About the COURAGE Study

A clinical research study is testing the safety and effectiveness of an investigational drug in men on BPH therapy experiencing OAB symptoms. The investigational drug, vibegron, is compared with a placebo. A placebo looks exactly like the investigational drug but contains no active medication. Over 1000 participants in approximately 135 study centers across North America and Europe are expected to take part in the COURAGE Study.

ClinicalTrials.gov – Study: NCT03902080 or Enroll Here.

Sponsor / Study Title:

Strategic Science & Technologies, LLC / A Phase 2B RESPOND, Multi-Center, Multiple-Dose, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Sildenafil Cream, 3.6% in Premenopausal Patients with Female Sexual Arousel Disorder (FSAD)

Protocol Number: SST-6006-013

Principal Investigator: Dr. Stuart D. Shoengold
(Study Doctor)


Location:

New Jersey Urology
225 Millburn Avenue
Building C, Suite 304
Millburn, NJ 07041

Sildenafil Cream RX FSAD

 

 

 

 

 

About the RESPOND FSAD Study

Sildenafil Cream, 3.6%, the therapy under study, is being developed for the treatment of Female Sexual Arousal Disorder, or FSAD. The RESPOND study is a Phase IIB trial assessing the benefit of Sildenafil Cream, 3.6%, administered prior to sexual activity, compared to placebo. Study participation lasts for six months.

This study also requires the participation of a partner. Patients should be in a stable, monogamous relationship, and partner should be willing to attend 2-3 study visits, and complete daily diaries.

Download the “FAQs pertaining to the Women’s Health Study for FSAD.”

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