STUDY TITLE:
A RANDOMIZED, CONTROLLED OPEN LABEL TRIAL OF DEGARELIX INTERMITTENT THERAPY VS. CONTINUOS ANDROGEN DEPRIVATION THERAPY WITH LEUPROLIDE OR DEGARELIX IN PATIENTS WITH CARCINOMA OF THE PROSTATE WITH BIOCHEMICAL FAILURE AFTER LOCALIZED THERAPY.

THE PURPOSE OF THIS TRIAL IS TO INVESTIGATE THE FEASIBILITY OF USING DEGARELIX ONE-MONTH DEPOT AS A FORM OF INTERMITTENT ANDROGEN DEPRIVATION THERAPY (IADT) THE RATIONALE OF IADT IS TO MINIMIZE THE NEGATIVE EFFECTS OF ANDROGEN DEPRIVATION THERAPY (ADT) AND MAXIMIZE QUALITY OF LIFE WHILE MAINTAINING TUMOUR RESPONSE AS MEASURED BY PROSTATE-SPECIFIC ANTIGEN (PSA) SUPPRESSION.

THE FEASIBILITY, ACCRUAL AND RESPONSE RATES OF DEGARELIX INTERMITTENT TREATMENT WILL BE EVALUATED, AND IF WARRANTED, THE TRIAL WILL BE CONTINUED AS A LONG-TERM CONTROLLED TRIAL.

STUDY DURATION: 14 MONTHS

STUDY INCLUSIONS:

• PATIENTS NEED A RISING PSA AFTER HAVING UNDERGONE PRIMARY THERAPY FOR LOCALIZED PROSTATIC CARCINOMA AND THE INVESTIGATOR ASSESSES THAT ANDROGEN DEPRIVATION THERAPY IS WARRANTED.
• PATIENTS SHOULD HAVE A SCREENING TESTOSTERONE WITHIN NORMAL RANGE (>220)
• HAS DOCUMENTED ABSENCE OF VISCERAL OR BONY METASTASIS EVIDENCED BY CT SCAN OR MRI SCAN OR BONE SCAN WITHIN THE LAST SIX MONTHS.
• FOR PATIENTS WITH RECURRENCE AFTER RADICAL PROSTATECTOMY OR CRYO THERAPY, A SERUM PSA CONFIRMED (TWO MEASUREMENTS) TO BE >2NG/ML HIGHER THAN A PREVIOUSLY CONFIRMED PSA NADIR.

STUDY EXCLUSIONS:

• HAS RECEIVED ADJUVANT HORMONE THERAPY 12 MONTHS PRIOR TO RANDOMIZATION.
• HAS A HISTORY OF UNCONTROLLED ASTHMA.
• HAS RECEIVED AN INVESTIGATIONAL DRUG WITHIN THE LAST 28 DAYS PRECEDING THE SCREENING VISIT OR LONGER IF CONSIDERED TO POSSIBLY IN FLUENCE THE OUTCOME OF THE CURRENT TRIAL.
• IS PART OF AN ONGOING TRIAL.

STUDY TITLE:
OVERACTIVE BLADDER /URINARY FREQUENCY AND URGE AND MIXED URINARY INCONTINENCE WITH PREDOMINANCE OF URGE INCONTINENCE EPISODES WITH AN OPEN LABEL EXTENSION.

PATIENTS WILL BE RANDOMIZED IN A BLINDED MANNER TO ONE OF THE FOLLOWING TREATMENT GROUPS(APPROXIMATELY 200 PATIENTS PER GROUP)

OXYBUTYNIN GEL (56MG OXYBUTYNIN/DAY) DAILY TOPICAL APPLICATION.
OXYBUTYNIN GEL(84 MG OXYBUTYNIN), DAILY TOPICAL APPLICATION
PLACEBO GEL, DAILY TOPICAL APPLICATION.

STUDY DURATION: 12 WEEKS

INCLUSION: PATIENTS MUST BE AT LEAST 18 YEARS OF AGE, WITH OVERACTIVE BLADDER SYMPTOMS OF URGE/ AND OR MIXED URINARY INCONTINENCE WITH A PREDOMINANCE OF URGE INCONTINENCE(BASED ON THE INVESTIGATORS DETERMINATION FOR AT LEAST 3 MONTHS.

EXCLUSION: INCONTINENCE THAT IS PREDOMINANTLY STRESS.
HISTORY OR EVIDENCE OF RENAL OR HEPATIC DYSFUNCTION: HISTORY OF CARDIOVASCULAR DISORDER, HYPERTENSION, HISTORY OF CEREBRAL SCLEROSIS, MYASTHENIA, PARKINSON'S DISEASE, MULTIPLE SCLEROSIS, OR SPINAL COR INJURY; LOWER URINARY TRACT SURGERY WITHIN 6 MONTHS PRIOR TO VISIT 1.


BPH Study

Study Title A multi-Center, Randomized, Double-blinded, Placebo-controlled Trial of the Safety and Efficacy of Ozarelix, in patients with lower Urinary Tract Symptoms (luts) due to Benign Prostatic Hypertrophy (BPH)

Study duration 2 years
First year is double blinded 15mg , 30 mg, placebo
Second year is open label treatment Ozarelix 15mg.

Inclusion Criteria

Is the patient at least 50 years old.
Does the patient have an IPSS>13
Does the patient have a peak urinary flow rate(Qmax) of 4-15 ml/sec (utilizing the 2-second rule) established on a voided volume of at least 125ml?
Does the patient have a PSA >0.8 ng/ml?

Exclusion Criteria

Estrogens,phytoestrogens,androgens,antiandrogens or LHRH agonists within the past 4 (e.g. testosterone gel (androgel 1%), testosterone buccal (Striant), oxymetholone (anadrol-50), oxandrolone (oxandrin) esterified estrogen and methyltestosterone estratest bicalutamide casodex nilutamide nilandron, flutamide eulexin, leuprolide acetate lupron eligard viadur goserelin acetate zoladex or, 5a reductase inhibitors within the past 4months(e.g. finasteride proscar propecial, dutasteride avodart or,alpha blockers or anticholinergic preparations within the past 6 weeks(e.g. doxazosin cardura terazosin hytrin tamsulosin flomax alfuzosin uroxatrol oxybutinin ditropan tolteredine detrol-la amytriptyline elavil limbitrol or.

DO YOU EXPERIENCE URINARY STRESS INCONTINENCE?

Characterized by the loss or leakage of urine during activites such as:

• Coughing, laughing or sneezing
• Climbing stairs or bending
• Lifting, straining or other stressful activity

If you, or someone you know, are suffering from these symptons, we are seeking women, 18 years of age or older, to take part in a post-approval study to evaluate the long-term saftey and effectiveness of a treatment of stress incontinence.

To learn more, call Grazy Gonzalez at (310) 854-9898 ext. 141 or email gonzalezg@towerurology.com.