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Dr. Marks and research coordinator, Dr. Malu Macairan, discuss a new research proposal. |
| "Phase 1 Study of the Litx(tm) BPH System in Patients With Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)" |
| This is a phase 1 study to evaluate the safety and effectiveness of using the Litx(tm) BPH System in patients with LUTS due to benign prostatic hyperplasia (BPH). Sponsor: Light Sciences Oncology, Inc. |
| "Randomized Double-blind Placebo Controlled Trial of Intradetrusor Injections of Botox® for the Treatment of Urinary Incontinence Secondary to Benign Prostatic Obstruction – BTX0621" |
| This is a 6 month trial that will investigate the comparative efficacy, safety and patient satisfaction of intradetrusor injections BOTOX® . Qualified subjects are men 40 to 90 years of age who experience residual signs and symptoms of overactive bladder 3 months after an obstruction relieving procedure. Allergan, Irvine, CA. |
| "Diagnostic and Prognostic Utility of Prostate Cancer Specific Molecular Gene Rearrangements and other Markers" |
| This is an ongoing study to determine the frequency of the occurrence of prostate cancer specific gene fusion transcripts as a result of the somatic molecular gene rearrangements that occur in a prostate cancer cell. We will detect the presence of these prostate cancer markers in total RNA samples isolated from the archived biopsy frozen tissue specimens. Gen-Probe, San Diego, CA. |
| "A phase 2, Randomized, Double-blind, Parallel Group, Placebo-Controlled, MultiCenter Study to Evaluate the Urodynamics and Safety of YM178 in Men with Lower Urinary Tract Symptoms and Bladder Outlet Obstruction" |
| This is a 4 month randomized study to determine the urodynamic safety and efficacy of YM178, a selective beta-3 adrenoreceptor agonist, in men 45 years and older with lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO). Astellas, Deerfield, IL. |
| "A two-arm, open label, randomized, multi center pharmacokinetic and long term safety study of intramuscular injections of 750 mg and 1000 mg testosterone undecanoate in hypogonadal men" |
| This is a 3 year randomized trial to identify a dosing regimen that would provide adequate serum total testosterone replacement in hypogonadal men. Indevus, Lexington, MA. |
| "PCA 3 feasibility study" |
| This study is being done to evaluate an investigational urine laboratory test for prostate cancer detection. Sponsor: Gen-Probe, San Diego, California. |
| "A randomized, double-blind, placebo controlled, parallel group study of the efficacy and safety of Dustasteride 0.5 mg administered orally once daily for four years to reduce the risk of biopsy detectable prostate cancer " |
| This is a 4 year multi-center trial to determine the efficacy and safety of dutasteride in preventing the development of prostate cancer to men who are at risk. Sponsor: Glaxo SmithKline, Research Triangle Park, North Carolina. |
| "GTX: A randomized, double blind, placebo controlled, multi-center efficacy and safety study of Toremifene citrate for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy " |
| This is a 2 year placebo-controlled trial to determine the efficacy and safety of torimefene citrate in the prevention of osteoporosis in men on androgen deprivation therapy for prostate cancer. Sponsor: GTx, Inc., Memphis, TN |
| "Concentration of prostate disease serum markers in response to 5 -a-Reducatase inhibitor therapy. Beckman Coulter, San Diego, CA." |
| "Study of Benign and Malignant Tissues of Native Japanese and Japanese-American Men" |
| In vivo comparative study of human prostate tissue to possibly explain the disparate incidence of clinical prostate cancer between asian and western men. Tissue studies will be focused on the effects of soy (isoflavones), dietary fat (lipoxygenase), and inflammation (GST Pi) as potential determinants of clinical cancer in the two groups and ultimately, as therapeutic and preventive targets. Sponsors: CaPCURE, Santa Monica, CA and Elsa Pardee Foundation, Chicago, IL |
| "Effects of testosterone administration on prostate tissues of men with 'A.D.A.M.' (Androgen Deficiency of Aging Male)" |
| This is a 6-month placebo controlled study aimed at evaluating the effects that exogenous testosterone may have on the prostate. Clinical, hormonal, radiographic and immunohistochemical measurements will be done at baseline and 6 months after randomization . Eligible patients are men over 55 years of age with appropriate score on the Morley index, serum PSA level below 10.0 ng/ml, no history or clinical evidence of prostate cancer, and exhibit a baseline morning serum testosterone level of less than 300 ng/dl. |
| "A Multi-Center, Double-Blind, Double-Dummy, Randomized, Placebo and Tamsulosin Controlled Parallel Group Study to Assess the Efficacy and Safety of UK-338,003 in Subjects with Lower Urinary Tract Symptoms Due to Benign Prostatic Obstruction" |
| This is a 12-week, phase II clinical trial designed to evaluate the safety and efficacy of an alpha 1 blocker (UK-338,003) in patients with symptoms due to benign prostatic obstruction. This trial also aims to identify the most effective dose for future clinical studies. Eligible patients are symptomatic men 40 years and above with documented evidence of BPH by digital exam or transrectal ultrasonography. Sponsor: Pfizer Inc., New London, CT |
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"Evaluation of Safety and Tolerability of Transurethral Absolute Ethanol Injection for the treatment of Benign Prostatic Hyperplasia (BPH)" |
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An early phase II, multi-center trial to evaluate the use of intraprostatic injection of dehydrated alcohol for the treatment of BPH. This minimally invasive procedure is being developed to successfully produce tissue ablation enough to relieve obstruction while avoiding serious complications and side effects. Eligible patients are men with clinical BPH who have not undergone invasive treatment. Sponsor: American Medical Systems, Inc.,Minnetonka, MN. |
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"The Development of BPSA as a Potential Marker For Benign Prostatic Disease" |
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A prospective and retrospective study to correlate the serum levels of BPSA, a newly discovered molecular form of prostate specific antigen (PSA), with different prostate tissue components. Retrospective material for the project will be derived from a rich database of patient information and specimens, saved from recently-completed randomized clinical trials of finasteride and saw palmetto extract. Prospective materials will be derived from ongoing patients who are currently being managed with ‘watchful waiting’ or a spectrum of medical therapies. The study hopes to define the potential of BPSA as a biomarker for BPH and its role in the diagnostic and therapeutic management of clinical BPH. Sponsor: Hybritech Corp., San Diego, CA. |
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"A Single-Arm, Open Label Study of Viadur in Community-based Patients with Advanced Prostate Cancer" |
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This is a phase IV prospective study to evaluate the efficacy and safety of Viadur, a leuprolide acetate implant, in a community-based population of patients with advanced prostate cancer and to assess the impact of the implant on patient’s functioning, activity level and quality of life. Eligible patients are patients who have adenocarcinoma of the prostate and have successfully completed treatment with leuprolide implant on ALZA Corporation Protocol. Sponsor: Bayer Corporation, West Haven, CT. |
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"Herbal Therapy for BPH" - Enrollment Now Complete |
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USRF has undertaken a very historic clinical trial: the first U.S. pharmaceutical-style evaluation of a promising herbal therapy for men with symptomatic BPH (Benign Prostatic Hyperplasia). While herbal or phyto therapy was previously considered outside of the purview of the medical establishment, two review articles on this topic appeared in major urology journals in the past year. The most promising agent is an extract of Saw Palmetto, a dwarf palm indigenous to the southeastern United States and the West Indies. In some European countries, this extract is the most common treatment for BPH. USRF has agreed to participate with major universities, plant therapy specialists, and a well-respected nutrition company to evaluate this agent in men with symptomatic BPH, as an alternative to drug or invasive therapies. The study is a randomized, double-blind trial of a Saw palmetto-based compound vs. placebo. End points include not only symptoms and flow rate, but also a battery of tissue studies, aimed at discerning a possible mechanism of action. |
Serenoa repens
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Read the statement from a recent NIH conference about nutritional therapy. |
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Additional On-line Information on Phytotherapy: |
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