The Brady Prostate and Urologic Health Centers at New York Presbyterian Hospital, Cornell University, are proud to announce several clinical trials open for enrollment. These clinical trials are IRB (Institutional Review Board) approved.

CLINICAL TRIALS FOR BENIGN PROSTATIC HYPERPLASIA

Symptoms of Benign Prostatic Hyperplasia (BPH) include:

• Getting up multiple times during the night to urinate
• Weak or intermittent stream
• Straining or waiting for the stream to start
• Sensation of not emptying your bladder completely
• Increased frequency or urgency of urination

COMPLEMENTARY AND ALTERNATIVE MEDICINE FOR UROLOGICAL SYMPTOMS. A MULTI-CENTER DOUBLE-BLIND CLINICAL TRIAL OF SERENOA REPENS (SAW PALMETTO) FOR BENIGN PROSTATIC HYPERPLASIA (IRB# 0801009602)

The research is being sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Health.

Recruiting male patients with Benign Prostatic Hyperplasia (BPH). Patients must be at least 45 years old, in general good health and have not had prostate surgery.

This research study involves administering a dietary supplement, plant extract also known as herbal therapy called saw palmetto. Preliminary studies have shown it to be effective in reducing the symptoms of an enlarged prostate though it has not been FDA approved for this purpose.

RANDOMIZED DOUBLE-BLIND PLACEBO CONTROLLED TRIAL OF INTRADETRUSOR INJECTIONS OF BOTOX FOR THE TREATMENT OF REFRACTORY OVERACTIVE BLADDER SECONDARY TO BENIGN PROSTATIC OBSTRUCTION (IRB# 0702009001)

Recruiting male patients 40–90 years old with urinary frequency, urgency and/or incontinence after having a surgical procedure on the prostate. Patients must have a benign enlarged prostate and be in general good health.

This research study involves an injection of Botox into the bladder. Preliminary studies have shown it to be effective in reducing urinary symptoms though it is not FDA approved for this purpose.

Participation will last 10 months and involves 7 office visits.

A PILOT STUDY TO MEASURE THE EFFICACY OF LONG-ACTING TOLTERODINE ON CONTINUED DETRUSOR OVERACTIVITY IN PATIENTS THAT HAVE UNDERGONE TREATMENT FOR BLADDER OUTLET OBSTRUCTION (IRB# 0506007934)

Recruiting male patients at least 40 years old with overactive bladder (many trips to the bathroom, and urgency with or without the ability to hold urine) that have undergone treatment for bladder outlet obstruction (noncancerous enlargement of the prostate gland to the point where it interferes with normal urine flow though the urethra and causes bladder emptying abnormalities).

Tolterodine tartrate ER (extended release) has been developed by Pfizer, Inc. and is approved by the United States Food and Drug Administration (FDA) for the treatment of overactive bladder. Tolterodine tartrate ER is marketed under the trade name Detrol® LA. Several studies have shown that enlarged prostate causes overactive bladder. The purpose of this study is to learn the effect of Tolterodine tartrate ER (Detrol® LA) versus placebo (no active study medication) on patients who have symptoms of overactive bladder in patients that have undergone treatment for bladder outlet obstruction.

Participation will last 6 months and involves 4 office visits.

For more information about any of the above listed trials please contact Celeste Egan, NP 212-746-1626.

CLINICAL STUDIES FOR PROSTATE CANCER

PHASE II TRIAL OF SOY PROTEIN BEFORE RADICAL PROSTATECTOMY

This research trial studies the possible beneficial effects of soy protein on the prevention of prostate cancer.

The purpose of the study is to determine whether the daily consumption of the dietary supplement soy protein, given for 4 - 8 weeks before radical prostatectomy, can cause beneficial changes in prostate tissue. Such beneficial effects could be the suppression of cancer cell division or shrinking of the prostate.

This study is recruiting men who are scheduled for surgical removal of the prostate as a treatment for cancer. Either soy protein or placebo (non-active material) is given and the effect on cancer within the prostate is evaluated.

For more information about this study, you may contact the office of Dr. Peter Schlegel at (212) 746-5491.

RANDOMIZED PLACEBO-CONTROLLED ADJUVANT STUDY OF PREVENTION OF PROSTATE CANCER RECURRENCE AFTER RADICAL PROSTATECTOMY BY SOY PROTEIN

This research study is recruiting men who have recently (within a 6-week period) undergone a prostatectomy for prostate cancer and are at risk for prostate cancer recurrence.

This study is researching whether treatment with soy protein prevents or delays prostate cancer recurrence in men with undetectable PSA (Prostate Specific Antigen) levels following a radical prostatectomy. Individuals who enroll in this study will receive either soy protein or a placebo (inactive material) and be followed for prostate cancer recurrence by PSA blood tests.

The potential benefit of the study is that the consumption of soy protein per day could inhibit the growth of prostate cancer and reduce the risk of recurrence after a radical prostatectomy.

For more information about this study, you may contact the office of Dr. Peter Schlegel at (212) 746-5491.

A PHASE I/II DOSE ESCALATION TRIAL OF MULTIPLE DOSES OF MLN2704 IN SUBJECTS WITH METASTATIC ANDROGEN-INDEPENDENT PROSTATE CANCER

Recruiting men with hormone-refractory, metastatic prostate cancer with disease progression on imaging studies and/or rising PSA. MLN2704 is a toxin-conjugated anti-PSMA (prostate specific membrane antigen) monoclonal antibody treatment that will be administered over 12 weeks. Patients who received prior monoclonal antibody treatment, including Prostacint, as well as previous chemotherapy or radiation therapy within 6 weeks prior to enrollment will not be eligible.

The purpose of the study is to monitor the effects of MLN2704 on patients with prostate cancer. Patients who show >50% decline in PSA or partial or complete response in measurable disease may receive additional treatment.

For more information about this study, you may contact the GU Oncology staff at (212) 746-5430 or (212) 746-2920.

A SERUM LEVEL-TARGETED STUDY INVESTIGATING THE SAFETY AND PHARMACOKINETICS OF ORALLY ADMINISTERED GALLIUM MALTOLATE IN PATIENTS WITH VARIOUS REFRACTORY MALIGNANCIES

Recruiting patients with progressive metastatic or locally recurrent prostate cancer.

The treatment being studied in this trial is the orally administered drug, Gallium Maltolate. Gallium Maltolate has been shown to have antineoplastic properties likely due to its ability to inhibit ribonucleotide reductase, a key enzyme in the regulation of DNA synthesis. The treatment will be administered on days 1-28 over a 42-day treatment cycle. Stable or responding patients may receive up to 6 cycles.

Patients who have optic neuritis or utilize diuretics are not permitted to participate in this study.

For more information about this study, you may contact the GU Oncology staff at (212) 746-5430 or (212) 746-2920.

CLINICAL STUDIES FOR ADVANCED KIDNEY CANCER

ROLE OF RENAL BIOPSY IN THE PREOPERATIVE DETERMINATION OF HISTOLOGY IN PATIENTS WITH RENAL CELL CARCINOMA

This study consists of intraoperative renal biopsies performed prior to radical or partial nephrectomy with subsequent FISH (Flourescent In Situ Hybridization) analysis for pathological interpretation.

The purpose of the study is to attempt to determine preoperative pathology prior to surgery with the idea of avoiding surgery in certain individuals.

For more information about the study, you may contact the office of Dr. Douglas Scherr at (212) 746-5788.

A PHASE II TRIAL OF ALL-TRANS RETINOIC ACID (ATRA-IV) AND INTERFERON ALFA-2B IN PATIENTS WITH ADVANCED RENAL CANCER

Recruiting patients with histologically confirmed metastatic kidney cancer and bidimensionally measurable disease. This trial is evaluating the effects of ATRA-IV and Interferon Alfa on metastatic kidney cancer. Patients will self administer Interferon on a Monday-Friday schedule, and receive ATRA-IV once a week via IV infusion.

Treatment cycles last 8 weeks and stable or responding patients may continue on 8-week cycles. Patients may have received prior Interferon treatment but no more than one prior chemotherapy and/or immunotherapy treatment is permitted.

For more information about this study, you may contact the GU Oncology staff at (212) 746-5430 or (212) 746-2920.

A PHASE I TRIAL OF ALL-TRANS RETINOIC ACID (ATRA-IV) AND DEPAKOTE (SODIUM VALPROATE) IN PATIENTS WITH ADVANCED SOLID TUMOR MALIGNANCIES

Patients with histologic confirmation of a solid tumor malignancy with clinical evidence of metastatic disease and failure of one standard therapy are being recruited for this study.

Sodium Valproate and ATRA-IV are being tested as treatments for advanced solid tumor malignancies including kidney cancer. Sodium Valproate is an anti-convulsant that also is a histone deacetylase inhibitor. Pre-clinical studies show it enhances the anti-tumor activity and differentiation effects of retinoids such as ATRA-IV. Patients will receive oral Sodium Valproate and ATRA-IV by infusion once a week for 8-week cycles. Stable or responding patients may continue on 8-week cycles.

Those with a history of pancreatitis, thromboplebitis, pulmonary embolism, epilepsy or a seizure disorder taking anti-convulsant medication are not eligible.

For more information about this study, please contact the GU Oncology staff at (212) 746-2920 or (212) 746-5430.

CLINICAL STUDIES FOR SUPERFICIAL BLADDER CANCER

RANDOMIZED PLACEBO CONTROLLED PHASE II STUDY OF CELECOXIB IN PATIENTS WITH RECURRENT SUPERFICIAL BLADDER CANCER

The goal of this study is to assess the role of Celecoxib (celebrex) in the prevention of superficial bladder cancer. Celecoxib is an anti-inflammatory medication that has shown some benefit in the prevention of colon cancer and is now being tested for its effect on superficial bladder cancer.

Patients are given celebrex free of charge and they are monitored in the standard fashion for one year.

For more information about this study, you may contact the office of Dr. Douglas Scherr at (212) 746-5788.

EFFECTIVE TUMOR IMMUNOTHERAPY IN BLADDER CANCER

This protocol employs leukophoresis pre and post BCG therapy in patients with superficial bladder cancer in an attempt to identify a specific CD-8 lymphocyte response to tumor antigen that is initiated by BCG.

BCG is an immunotherapy instilled into the bladder for the treatment of superficial bladder cancer. Patients are treated in the standard fashion with the exception of giving some special blood studies pre and post therapy with BCG.

For more information about the study, you may contact the office of Dr. Douglas Scherr at (212) 746-5788.

CLINICAL STUDIES FOR ADVANCED BLADDER CANCER

A SERUM LEVEL-TARGETED STUDY INVESTIGATING THE SAFETY AND PHARMACOKINETICS OF ORALLY ADMINISTERED GALLIUM MALTOLATE IN PATIENTS WITH VARIOUS REFRACTORY MALIGNANCIES

Recruiting patients with histologically/cytologically confirmed transitional cell bladder cancer and at least one bidimensionally measurable lesion.

The treatment being studied in this trial is the orally administered drug, Gallium Maltolate. Gallium Maltolate has been shown to have antineoplastic properties likely due to its ability to inhibit ribonucleotide reductase, a key enzyme in the regulation of DNA synthesis. The treatment will be administered on days 1-28 over a 42-day treatment cycle. Stable or responding patients may receive up to 6 cycles.

Patients who have optic neuritis, utilize diuretics, and have had more than 2 prior chemotherapy regimens are not permitted to enroll in the study.

For more information about this study, you may contact the GU Oncology staff at (212)746-2920 or (212)746-5430.

A RANDOMIZED PHASE III STUDY COMPARING SEQUENTIAL CHEMOTHERAPY (AG-TP) TO CISPLATIN AND GEMCITABINE (GC) AS ADJUVANT TREATMENT AFTER CYSTECTOMY FOR TRANSITIONAL CELL CARCINOMA OF THE BLADDER

Recruiting patients with pathologic confirmation of complete resection of T3-4 and/or pelvic node positive transitional cell carcinoma of the bladder with negative margins. Patients should not have had prior systemic chemotherapy or irradiation of the bladder. Patients should have normal cardiac function.

Eligible patients will be randomized to receive either GC(arm A) or AG-TP(arm B). Treatment on either arm must start within 3 months of definitive surgery. The scheduled treatment duration for both arms is 16 weeks. GC will be administered every 4 weeks for a total of 16 weeks. AG will be administered once during each two-week cycle for a total of 4 cycles or 8 weeks. This treatment is followed by the TP regimen administered at 2-week intervals for 4 cycles or 8 weeks.

For more information about this study, you may contact the GU Oncology staff at (212)746-2920 or (212)746-5430.

A PHASE II STUDY OF CISPLATIN, GEMCITABINE, AND ZD1839 (IRESSA) FOR THE TREATMENT OF ADVANCED UROTHELIAL TRACT CARCINOMA

Recruiting patients with biopsy proven, metastatic transitional cell carcinoma of the urothelial tract. Patients must have tissue from the primary tumor or biopsy of a metastatic site for EGFR expression determination available. Patients must not have had prior systemic chemotherapy except single agent chemotherapy used as a radiosensitization agent. Prior intravesical chemotherapy is permissible; prior adjuvant or neoadjuvant therapy is not. No prior treatment with ZD1839. No greater than grade 1 pre-existing sensory or motor neuropathy, active chronic severe gastrointestinal disorder causing nausea or diarrhea, active chronic severe desquamative cutaneous disorder, active severe corneal or inflammatory ocular disorder.

Eligible patients will receive a maximum of 6 cycles of combination therapy consisting of gemcitabine, cisplatin and ZD1839. Each treatment cycle is 21 days. Patients can be maintained on ZD1839 for up to five years. Scans are required every 3 cycles.

For more information about this study, you may contact the GU Oncology staff at (212)746-2920 or (212)746-5430.

CLINICAL STUDIES FOR SEXUAL MEDICINE

The Sexual Medicine Program of New York Presbyterian HospitaL/Cornell University is pleased to announce the opening of several clinical trials for men. All clinical trials have been approved by the IRB.

For more information, please call Pat Guhring, R.N., Coordinator of the Sexual Medicine Program, at (212) 746-0183. You may also obtain information about the Sexual Medicine Program at http://www.cornellurology.com/uro/cornell/sexualmedicine/

STUDY OF THE SAFETY AND EFFECTIVENESS OF THE MENTOR 2-PIECE INFLATABLE PROSTHESIS

The purpose of this study is to collect information on the satisfaction of this new 2-piece inflatable penile prosthesis. The 2-piece device is manufactured by Mentor Urology who make one of the currently available 3-piece devices (Alpha-1 Titan).

The population for this study consist of men, aged 18 years or older, who have documented erectile dysfunction, who are candidates for penile implant surgery and who opt for this procedure.

This study is 12 months long and requires a screening visit, performance of the implant surgery and 3-4 month follow-up visits. Pre-operative blood and urine samples are required. Subjects will also be required to complete Patient Satisfaction and Quality of Life Questionnaires.