Philadelphia University + Thomas Jefferson University

Approved Department of Urology Clinical Trials

Protocol List: All Enrolling Protocols in the Dept of Urology

Version December 2017

INDICATION / PI DRUG /TREATMENT ACTION KEY INCLUSION / EXCLUSION
Urothelial Cancer Treatment /Dr Gomella FKD Therapies

Enrolled 6, 1 screen fail, 1 in screening
Instiladren rAd-IFN/Syn3 administered intravescially NMBIC CIS or Ta/T1 high grade disease. BCG Unresponsive. Have received at least 2 previous courses of BCG within a 12 month period.  Absence of concomitant upper tract Urothelial ca, or urothelial ca within the prostatic urethra. No history of other cancers within the past 5 years       
Prostate Cancer/Dr Lallas Medivation  EMBARK           Enrolled-8, 1 in screening
Enzalutamide monotherapy      Enzulatamide plus Leuprolide or    Placebo and Leuporlide Patients with Rising PSA after definite treatment. Non mestastatic disease.  Post Prostatectomy PSA must be at least 1.0  Post Radiation txt PSA must be at least 2.0 Doubling time must be less than 9 months.
Neurogenic Bladder/Dr Shenot IPSEN- D-FR-52120-222 Enrolled 1 DYSPOR600, 800 or placebo randomized Patients with Multiple Sclerosis or Spinal cord injury. Patients must be self cathing at least 4 times a day. No indwelling catheters can be present. Patients must leak in between cathings.
Upper Tract Urothelial    
Mitogel Enrolled 1 Mitomycin Patients muts have had a PSA above 1.5 in the past year.  No DRE in the past 96 hours prior to blood draw. Able to donate 5-5mL tubes of blood.
OPKO Diagnostics  4K score Enrolled 16
Need 14-- 1.5-4 Need 5-4.1-10.0 Need 15--10 and above
Blood Draw Patients muts have had a PSA above 1.5 in the past year.  No DRE in the past 96 hours prior to blood draw. Able to donate 5-5mL tubes of blood.

Pending Protocols in Urology

INDICATION / PI DRUG /TREATMENT ACTION KEY INCLUSION / EXCLUSION
Priority- SIV 1/18/18 @10am Confirm MDx and Select MDx Confirm and Select MDx Assay testing on patients with prior negative prostate biopsies, that continue to have persistant risk factors, such as elevated PSA and abnormal DRE
CINJ Docetaxel +/- Cytoredutive Prostatectomy
Cytoreductive Prostatectomy with ADT plus 6 cycles of Docetaxel. Vs. ADT and Docetaxel Phase 2.5 Cytoreductive Prostatectomy with combined therapy in newly diagnosed Metastatic Prostate ca.
SWOG BCG naïve patients Randomized trial of different BCG strains. TICE vs Tokyo Ta,T1 or CIS diagnosed within the last 90 days.
ALTOR
BCG Unresponsive BCG plus ALT-803 BCG Unresponsive High Grade Non-Muscle Invasive disease.

NON-Urology based trials

INDICATION / PI DRUG /TREATMENT ACTION KEY INCLUSION / EXCLUSION
Prostate Cancer/Dr Simone Carefor- Pre-op dietary restrictions Two week caloric restrictive diet using a n app to track consumed calories Patients must be scheduled for a Prostatectomy and willing to cut their daily calorie consumption and record it.  BMI> 21 at the time of study enrollment. Daily caloric consumption of >1000 calories. No confirmed diagnosis of another malignancy within the past 6 months
R21 Subharmonic Imaging/Dr Halpern Sub-Harmonic ultrsound Contrast enhanced Sub-Harmonic ultrasound for prostate biopsy Elevated PSA. For patients being scheduled for Standard of care TRUS biopsy.
Progenics/Dr Intenzo SPECT/CT Imaging SPECT/CT imaging for patients scheduling for a radical Prostatectomy Confirmed biopsy with the last 12 months. Gleason 3=4=7 or higher. Scheduled to undergo a radical prostatecomy. No Prior treatments
VPAC Bladder/ Dr Thakur PET/CT imaging Imaging for patients scheduled to undergo an expirative surgery or a biopsy of a suspected metastatic lesion Diagnosis of a Urothelial cancer. No allergic reactions of study components.
Active Surveillance Protocol/Dr Ron Myers Active Surveillance for Low Risk Prostate Cancer Enrolled 11  Questionnaires about deciding on Active Surveillance for both patient and physician Low Risk Prostate Cancer