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Urology Practice Management - February 2015, Vol 4, No 1 - Clinical Trials Tracker

The following clinical trials are currently recruiting patients with urologic conditions for inclusion in several investigations. Each trial description includes the NLM Identifier to use as reference with ClinicalTrials.gov.

Prostate Cancer

  1. Radiation With or Without Androgen Deprivation Therapy

    This phase 3, parallel-assignment, open-label study examines the effectiveness of radiation therapy when it is given with or without androgen deprivation therapy comprising a lutein­izing hormone-releasing hormone (LHRH). Patients aged ≥18 years with prostate cancer may enroll if other criteria are met. Patients are randomized to receive (1) external-beam radiation therapy once daily on days 1 to 5 or (2) an LHRH agonist subcutaneously or as an injection every 1 to 3 months with oral flutamide or bicalu­tamide for 6 months. Beginning 8 weeks after the first LHRH injection, patients will undergo radiotherapy as in the non-LHRH group.

    The primary objective is overall survival (OS), measured from the date of randomization to the date of death due to any cause. Secondary outcome measures include biochemical failure, local or regional disease recurrence, and distant metastasis. This study is expected to enroll 1520 patients at sites throughout the United States. For more information, contact Alvaro Martinez, MD, FACR, at 248-553-0606 or alvaro.martinez@rtsx.com. The NLM Identifier is NCT00936390.

  2. Safety and Efficacy of Enzalutamide

    This phase 3, parallel-assignment, double-blind study assesses the safety and efficacy of enzalutamide in patients with nonmetastatic prostate cancer. Patients aged ≥18 years who have ongoing androgen deprivation therapy with a gonadotropin-releasing hormone agonist/antagonist or prior bilateral orchiectomy may enroll if other criteria are met. Patients are randomized to placebo or 160 mg of enzalutamide daily.

    The primary outcome measure is metastasis-free survival. Secondary outcome measures include OS, time to pain progression, or time to opiate use for prostate cancer pain. Time to first use of cytotoxic chemotherapy or new antineoplastic therapy, and time to prostate-specific antigen (PSA) progression are also collected. This study is expected to enroll 1560 patients at sites throughout the United States. For more information, contact Mohammad Hirmand, MD, at 415-543-3470 or mohammad.hirmand@medivation.com, or Kristina Wilson at 415-543-3470 or kristina.wilson@medivation.com. The NLM Identifier is NCT02003924.

  3. 3 DCVAC Added to Standard Chemotherapy

    The objective of this phase 3, parallel-assignment, double-blind study is to determine whether DCVAC/PCa added to standard-of- care chemotherapy can improve survival times for patients with metastatic castration-resistant prostate cancer. Patients aged ≥18 years with disease progression despite androgen deprivation therapy, a life expectancy of ≥6 months, and an Eastern Cooperative Oncology Group performance status of 0 to 2 may enroll if other criteria are met. Patients are randomized to receive either DCVAC or placebo with standard-of-care therapy consisting of docetaxel and prednisone.

    The primary outcome is OS, measured over a time frame of 124 weeks. Secondary outcome measures include radiographic progression-free survival (PFS), and duration to PSA progression and skeletal-related events. This trial is expected to enroll 1170 patients at several sites throughout the United States. For more information, contact Richard Kapsa at kapsa@sotio.com. The NLM Identifier is NCT02111577.

  4. Enzalutamide and Mifepristone

    This phase 1/2 trial studies the side effects, efficacy, and best dose of enzalutamide and mifepristone combination therapy. Patients aged ≥18 years with metastatic hormone-resistant prostate cancer, an Eastern Cooperative Oncology Group performance status of ≤2, and evidence of castrate testosterone levels at <50 ng/dL may enroll if other criteria are met. Patients are randomized to receive either enzalutamide alone or in combination with mifepristone.

    Primary outcomes are the recommended phase 2 dose, defined as the highest mifepristone dose in combination with enzalutamide, and PFS. Secondary outcome measures include OS, radiographic PFS, pharmacokinetic parameters of the 2 drugs, and the androgen and glucocorticoid receptors’ expressions within circulating tumor cells. This study is expected to enroll 108 patients in Chicago, IL. For more information, contact Kelly O’Connor at 773-702-4653 or koconnor@medicine.bsd.uchicago.edu. The NLM Identifier is NCT02012296.

  5. Enzalutamide plus Dutasteride as First-Line Treatment

    The objective of this phase 2, open-label, single-group assignment study is to determine the effect of enzalutamide and dutasteride on the time to PSA level increase. Patients aged 65 to 85 years with prostate cancer who have a serum testosterone level of >1.7 nmol/L at time of screening and an Eastern Cooperative Oncology Group performance status of 0 to 2 may enroll if other criteria are met. All patients will receive daily enzalutamide and dutasteride orally.

    The primary outcome measure is PSA levels, measured from blood drawn every 6 weeks for 103 weeks. This trial is expected to enroll 40 patients in Rochester, NY, and Milwaukee, WI. For more information, contact Chunkit Fung, MD, at 585-275-9319 or chunkit_fung@urmc.rochester.edu, or Ayesha Khan at 585-275-3351 or ayesha_khan@urmc.rochester.edu. The NLM Identifier is NCT02213107.

  6. Calcitriol, Ketoconazole, and Hydrocortisone

    This single-arm, phase 1/2 trial studies the side effects, best dose, and efficacy of calcitriol when given in combination with ketoconazole and hydrocortisone in patients with advanced or recurrent prostate cancer. Patients aged ≥18 years with an Eastern Cooperative Oncology Group performance status of 0 to 2 or a Karnofsky performance score of 60% to 100%, a life expectancy >3 months, and hemoglobin ≥8 g/dL may enroll if other criteria are met. All patients will receive oral calcitriol daily according to protocol. Patients will receive ketoconazole orally 3 times a day on days 1 to 24 and days 4 to 24 in phase 1 and 2 of the trial, respectively. Oral hydrocortisone is given in phase 1 of the trial only. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

    Primary outcome measures include the maximum tolerated dose of calcitriol as well as PSA response rate. Secondary outcome measures are toxicity and objective tumor response as measured by a monthly physical exam and radiographic evaluation every 12 weeks. This study is expected to enroll 51 patients in Buffalo, NY. For more information, contact Donald L. Trump, MD, FACP, at 877-275-7724 or askrpci@roswellpark.org. The NLM Identifier is NCT00536991.

Overactive Bladder

  1. Myrbetriq versus Detrol LA

    This phase 4, crossover-assignment, double-blind, safety and efficacy study assesses the tolerability of Myrbetriq compared with Detrol LA in patients with overactive bladder (OAB), defined as symptoms of urinary frequency and urgency with or without incontinence. Patients aged ≥18 years who have had OAB for ≥3 months and are treatment-naïve to pharmaceutical agents for OAB may enroll if they are willing to complete a micturition diary and questionnaires, and if other criteria are met. Patients are randomized to one of the following sequences: (1) Myrbetriq/Detrol LA, (2) Detrol LA/Myrbetriq, (3) Myrbetriq/Myrbetriq, or (4) Detrol LA/Detrol LA.

    The primary outcome measure is patient tolerability as assessed by the Tolerability Scale of Overactive Bladder-satisfaction (OAB-S) questionnaire at weeks 8 and 18. Secondary outcome measures include patient preference at week 18 based on a 5-point scale, scaled ratings from the OAB-S questionnaire assessed at weeks 8 and 18, and the change from baseline in the number of incontinence episodes and micturitions per 24 hours as assessed at weeks 8 and 18. This study is expected to enroll 360 patients at sites throughout the United States. For more information, contact Astellas Pharma Global Development at 800-888-7704, extension 5473, or astellas.registra tion@astellas.com. The NLM Identifier is NCT02138747.

  2. Mirabegron in Older Adults

    This phase 4, parallel-assignment, double-blind trial assesses the safety, efficacy, and tolerability of mirabegron versus placebo in older patients with OAB. Patients aged ≥65 years who have had symptoms of wet OAB—ie, urinary frequency and urgency with incontinence—for ≥3 months may enroll if other criteria are met. Patients are randomized to mirabegron or placebo, and they may not participate in another interventional study from the time of screening until the final study visit.

    Primary outcome measures are the change in mean number of micturitions and incontinence episodes per 24 hours based on a 3-day micturition diary, the change in the mean volume voided per micturition, and quality-of-life scores as assessed by questionnaire. The change in patient perception of his or her bladder condition is also measured. Data are collected at baseline and 12 weeks. This study is expected to enroll 800 patients at sites throughout the United States. For more information, contact Astellas Scientific & Medical Affairs, Inc, at 800-888-7704, extension 5473, or astellas.registration@astellas.com. The NLM Identifier is NCT02216214.

  3. Urinary Incontinence in Pediatric Patients

    This phase 3, parallel-assignment, double-blind trial evaluates the safety and efficacy of onabotulinumtoxinA for the treatment of urinary incontinence due to OAB. Patients aged 12 to 17 years who have had OAB with urinary incontinence for ≥6 months and whose symptoms are not adequately managed with ≥1 anticholinergic agent may enroll if other criteria are met. Patients will be randomized to 1 of 3 treatment drug doses. The experimental drug is injected into the detrusor wall of the bladder on day 1 and is readministered as needed at intervals of ≥12 weeks.

    The primary outcome measure is the change from baseline in the number of daily episodes of urinary incontinence. Secondary outcome measures include the change from baseline in number of daytime micturition and urgency episodes; the change from baseline to scores on the 20-Item Pediatric Incontinence Questionnaire; the percentage of patients with nighttime urinary incontinence and a positive treatment response on the modified treatment benefit scale; and the volume that is voided per micturition. The time to a patient’s request or qualification for retreatment is also assessed. This study is expected to enroll patients within the United States as well as internationally. For more information, contact Allergan, Inc, at clinic altrials@allergan.com. The NLM Identifier is NCT02097121.

  4. Urinary Incontinence in Adults

    This phase 4, parallel-assignment, double-blind study evaluates the efficacy and safety of onabotulinumtoxinA versus placebo in achieving a 100% reduction in urinary incontinence in patients with OAB. Patients aged ≥18 years who have had OAB with urinary incontinence for ≥6 months that is not properly managed with an anticholinergic may enroll if other criteria are met. Patients are randomized to receive either onabotulinumtoxinA or placebo (normal saline) injected into the detrusor wall of the bladder on day 1, followed by an injection of onabotulinumtoxinA after ≥12 weeks. The second injection is provided as needed.

    Primary outcome measures are (1) the percentage of patients who achieve a 100% reduction in urinary incontinence, and (2) the change from baseline in the number of episodes of urinary incontinence; measures are assessed at baseline and week 12. Secondary outcome measures include the number of micturitions, daily urgency episodes, and nocturia episodes at week 12. This investigation is expected to enroll 258 patients in Shreveport, LA, and Mountlake Terrace, WA. For more information, contact Allergan, Inc, at clinicaltrials@allergan.com. The NLM Identifier is NCT01945489.

  5. Fesoterodine in Children Aged 6 to 17 Years

    This phase 3, parallel-assignment, open-label, safety and efficacy study will assess whether fesoterodine is a useful treatment in children with bladder muscle overactivity caused by a neurological condition. Patients aged 6 to 17 years may enroll if they have stable neurological disease and stable neurogenic detrusor overactivity, if other criteria are met. Patients will be randomized to receive fesoterodine PR 4 mg or 8 mg, oxybutynin extended release, or fesoterodine BIC 2 mg or 4 mg.

    The primary outcome measure is maximum cystometric bladder capacity. Secondary outcome measures include detrusor pressure at maximum bladder capacity, the presence of involuntary detrusor contractions, bladder volume at first involuntary detrusor contraction, and bladder compliance. The mean number of micturitions and/or catheterizations per day, incontinence episodes per day, and urgency episodes per day, and the mean volume voided per micturition or catheterization are also measured. All end points are assessed over a time frame of 12 weeks. This trial is expected to enroll 132 patients at locations throughout the United States. For more information, contact Pfizer’s clinical trials call center at 800-718-1021. The NLM Identifier is NCT01557244.

  6. Solifenacin Succinate and Mirabegron

    This phase 3, parallel-assignment, double-blind study examines the effectiveness of solifenacin succinate–mirabegron combination therapy versus either medicine administered alone or a placebo in the treatment of patients with OAB. Patients aged ≥18 years who have had symptoms of urinary frequency and urgency with incontinence for ≥3 months may enroll if they are able to (1) complete a micturition diary and questionnaires, (2) measure their vital signs at home at stipulated time points, and (3) meet other inclusion and exclusion criteria. Patients are randomized to receive solifenacin succinate–mirabegron combination therapy, either medication alone, or a placebo.

    Primary outcome measures are the change from baseline in the mean number of incontinence episodes and micturitions per 24 hours at the end of treatment. Secondary outcome measures are the change in the mean volume voided per micturition, symptom bother as assessed by questionnaire, and patient satisfaction. These end points are collected at baseline and 12 weeks. This trial is expected to enroll 3392 patients at sites throughout the United States. For more information, contact Global Clinical Science at astellas.registration@astellas.com. The NLM Identifier is NCT01972841.

  7. Oxybutynin Topical Gel in Pediatric Patients

    This phase 4, parallel­group, double-blind study evaluates the safety and efficacy of oxybutynin topical gel in children with neurogenic OAB. Patients aged 6 to 16 years may enroll if they are diagnosed with neurogenic bladder and meet additional criteria. Patients will receive either 10% oxybutynin chloride topical gel or placebo. The primary outcome is the percentage of catheterizations without a leaking accident over a time frame of 6 weeks. The trial is expected to enroll 96 patients at sites throughout the United States. For more information, contact Jaime May at 201-427-8853 or jaime.may@frx.com, or Branka Palic at 973-659-2171 or branka.palic@actavis.com. The NLM Identifier is NCT01192568.
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Last modified: March 18, 2015
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