Urology Research Department

Current Research Studies

The Urological Institute of Northeastern New York is participating in several clinical trials, including:

• Non-Metastatic Prostate Cancer with a rising PSA
• Prostate Cancer with a need for hormone therapy
• Non-Muscle Invasive Bladder Cancer
• Observational Penile Oximetry
• Testosterone Replacement on Penile Oxygenation

We are currently looking for patients for the following trials:

1. A Randomized, Open-Label, Phase 2 Trial Examining the Sequencing of Sipuleucel-T and Androgen Deprivation Therapy in Men with Non-Metastatic Prostate Cancer and a Rising Serum Prostate Specific Antigen after Primary Therapy

   Experimental: Arm 1: sipuleucel-T followed by ADT

   Beginning 2 weeks following the last sipuleucel-T infusion, subjects will receive one leuprolide acetate depot injection followed by a second injection 6 months later.

   Experimental: Arm 2: ADT followed by sipuleucel-T

   Beginning 12 weeks prior to the first sipuleucel-T infusion, subjects will receive one leuprolide acetate depot injection followed by a second injection 6 months later.

   Some Inclusion criteria:

   • Prior primary therapy for prostate cancer
   • Rising prostate specific antigen (PSA) with a PSA doubling time (PSADT) of = 12 months

   Some Exclusion criteria:

   • Prior sipuleucel-T therapy
   • Prior ADT therapy = 6 months prior to registration or more than 6 months duration in total
   • Disease-free and off treatment for 10 years for other stage III/IV malignancies or 5 years for other stage I/II malignancies
   • Prior experimental immunotherapy within 1 year
   • Received denosumab or XRT = 6 months prior to registration
   • Received chemotherapy or GM-CSF = 90 days prior to registration

   For more information on this study please go to clinicaltrials.gov study identifier NCT01431391.

2. Efficacy and Safety of a New Leuprolide Acetate 22.5 mg Depot Formulation in the Treatment of Prostate Cancer

   This in an open-label, multicenter, multiple-dose investigation of 2 doses of leuprolide acetate 22.5 mg administered with a 3-month interval to patients with histologically proven carcinoma of prostate who might benefit from medical androgen deprivation therapy. A total of up to 160 male patients will receive their first single intramuscular injection of leuprolide acetate 22.5 mg on Day 0 (after baseline assessment) and then after 3 months (Day 84). The study duration will be 6 months.

   For more information on this study please go to clinicaltrials.gov study identifier NCT01415960.

3. A Phase 3, Randomized, Active-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of EN3348 (MCC) as Compared with Mitomycin C in the Intravesical Treatment of Subjects with BCG Recurrent or Refractory Non-Muscle Invasive Bladder Cancer

   Refractory disease is defined as evidence of persistent high grade bladder cancer (Ta HG, T1, and/or CIS) at least 6 months from the start of a full induction course of BCG1 with or without maintenance/re-treatment at 3 months.

   Recurrent disease is defined as reappearance of disease after achieving a tumor-free status by 6 months following a full induction course of BCG1 with or without maintenance/re-treatment at 3 months. Subjects with recurrent disease must have recurred within 18 months following the last dose of BCG.

   For more information on this study please go to clinicaltrials.gov study identifier NCT01200992.

4. Observational study of Penile Oximetry in Men Presenting for Urologic Evaluation

   The oxygen level of the earlobes, things and penis are measured to determine the specific oxygen level. This is only a one time visit and is done during your regular appointment.

5. The Effect of Testopel Testosterone Replacement on Penile Oxygenation

   The study will test to see if testosterone replacement increasing the penile oxygenation and function. Patients will receive testosterone replacement known as Testopel prior to the insertion of the pellets the oxygen levels will be measured in the penis. There are 3 visits for this study that will coincide with your regularly scheduled visits. At each visit you will complete questionnaires and have your oxygen levels measured.

If you are interested in participating in a clinical trial,
contact the Urology Research Department at 518-262-8579.

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