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Urology Clinical Trials

IRB Control # 07F.202  

The purpose of this study is to determine whether the use of Polyphenol E (found in green tea) decreases the incidence of prostate cancer in men who have had a diagnosis of High Grade Prostatic Intraepitelial Neeoplasia (HGPIN) on prostate biopsy.

Title:   Phase II, Randomized, Double-blind, Multi-center, Study of Polyphenol E in Men with High Grade Prostatic Intraepithelia Neoplasia (HGPIN)

Site(s) and/or Type:  Prostate

Principal Investigator:  Raffaele Baffa, MD

Contact:  Christine Hubert, BA, Clinical Trial Coordinator
(215) 955-9954
Email:  Christine.hubert@jefferson.edu

Criteria:

  • Male, 30 - 80 years of age.
  • Diagnosis of HGPIN in at least 1 core of a 12 core prostate biopsy, no diagnosis of ASAP or prostate cancer
  • Prostate biopsy within the last 6 months.
  • PSA less than or equal to 10 ng/ml
  • No current us of drugs that affect PSA (testosterone, 5-alpha reductase inhibitors, etc).  Participants may stop these drugs prior to enrollment.
  • Must be willing to stop the use of nutritional and/or herbal supplements, and have a low consumption of tea.

Please note there are additional eligibility criteria.  The study center will determine if you meet all of the criteria.

Treatment:

Participants will be randomized to receive either a tablet form of green tea called Polyphenol E OR a Placebo tablet (sugar pill) to take each day for a 12-month period.  Participants will be required to attend 13 clinic visits over an approximately 14 month time period.  At the end of the study, a prostate biopsy will be performed.

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IRB Control # 06F.145

The purpose of this study is to test if treatment with Dutasteride can reduce the blood flow in benign prostate tissue compared to treatment with a placebo (an inactive pill that looks identical to Dutasteride but has no effect on the body).  The study will test whether treatment with Dutasteride can help improve detection of prostate cancer when combined with contrast-enhanced ultrasound, as compared to placebo.  Additionally, the study doctors will compare targeted biopsy of the prostate based upon contrast-enhanced ultrasound to a standard 12-core biopsy of the prostate to see which is better for detecting prostate cancer. 

Title:   US Prostate Cancer Detection with Dutasteride Pretreatment (NIH Grant No: 1R01CA118003-01A1)

Site(s) and/or Type:  Prostate

Principal Investigator:  Ethan Halpern, MD

Contact:  Kelly Coggins, Clinical Trial Coordinator
(215) 955-4202
Email:  Kelly.Coggins@jefferson.edu

Criteria:

  • Male, age 18 years or older
  • Need prostate biopsy due to elevated PSA and/or abnorma digital rectal exam
  • No current use of 5-alpha reductase inhibitors (e.g dutasteride or finasteride)
  • If diagnosed with prostate cancer- no treatment received
  • No prostate biosy within the last 30 days
  • No current Urinary tract infection or prostatitis (can be treated prior to enrollment)
  • Subject has acute coronary or pulmonary instability

Please note that are additional eligibility criteria.  The study center will determine if you meet all of the criteria.

Treatment:

Participants who qualify will be enrolled in the study and randomly assigned to receive either active study drug (dutasteride) or placebo for two weeks prior to the prostate biopsy procedure.  Participants will also receive an IV infustion of a contrast agent on the day of the ultrasound guided prostate biopsy.  By combining these 2 techniques (drug therapyand contrast ultrasound), we hope to be able to further improve the detection of prostate cancer.

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IRB Control # 06C.342 

Purpose:  HIFU - High Intensity Focused Ultrasound - The purpose of this research study is to measure the saftey and effectiveness of the Ablatherm Integrated Imaging for the treatment of low risk prostate cancer by using ultrasound waves traveling through the rectal wall focused on the prostate gland.

Title:  Ablatherm Integrated Imaging High Intensity Focused Ultrasound (HIFU) for the treatment of Low Risk Prostate Cancer

Site(s) and/or Type:  Prostate

Principal Investigator: Edouard Trabulsi, MD

Contact:  Christine Hubert, BA, Clinical Trial Coordinator
(215) 955-9954
Email:  Christine.hubert@jefferson.edu

Criteria:

  • Male age 60 years or older
  • Patients diagnosed with prostate cancer clinical stage T1a, T1b, T1c or T2a
  • Patients with at least one positive biopsy within the last 6 months
  • Cannot have received any other treatment for prostate cancer
  • Patients with total prostate volume < 40 cc, AP diameter of prostate <25 mm
  • Patients with normal recal anatomy
  • No evidence of seminal vesicle or lymph node involvement, no metastatic disease

Please note that are additional eligibility criteria.  The study center will determine if you meet all of the criteria.

Treatment:

Participants will receive one treatment of Ablatherm High Intensity Focused Ultrasound (HIFU).  HIFU treatment is designed to treat localized prostate cancer using ultrasound waves traveling through the rectal wall which are focused on the prostate gland.  The waves produce intense heat leading to the destruction of the prostate tissue within the targeted zone without damaging the surrounding tissue.  Participants will be required to attend follow-up visits for 24 months post treatment.

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IRB Control # 07C.303

The purpose of the study is to test the safety and effectiveness of a drug called Advodart (dutasteride) in combination with Casodex, compared to placebo and Casodex in further reducing the progression of prostate cancer and delaying the need for more aggressive treatment (i.e. chemotherapy).

Title:   A Randomized, Double-blinded, Parallel Group Study Comparing Casodex 50mg plus Placebo to Casodex 50mg plus dutasteride 3.5mg Administered for 18 months to Men with Prostate Cancer Who Have Failed First-Line Androgen Deprivation Therapy (Assessed by Rising PSA) Followed by a Two-Year Extension Phase

Site(s) and/or Type:  Prostate

Principal Investigator: Leonard Gomella, MD

Contact:  Christine Hubert, BA, Clinical Trial Coordinator
(215) 955-9954
Email:  Christine.hubert@jefferson.edu

Criteria:

  • Male, age between 40 and 85 years of age
  • Failed first-line adrogen deprivation therapy by progression of PSA results (3 rises, at least 4 weeks apart)
  • PSA between 2 ng/ml and 20 ng/ml, Testerone <50 ng/ml
  • Prostate cancer with no symptoms, no metastatic disease
  • No other hormonal therapy (except GnRH analogue) within the past 6 months

Please note that are additional eligibility criteria.  The study center will determine if you meet all of the criteria.

Treatment:

Participants will be randomly assigned (like a flip of a coin) to receive one of the following study treatments:

- Casodex 50mg plus Dutasteride 3.5 mg once daily for 18 months

- Casodex 50mg plus Placebo (inactive substance) once daily for 18 months

Particpants will be required to come in for study visits during the 18 month period. Participants who complete the study and whose prostate cancer remains stable will be offered to continue their treatment for another 2 years.

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IRB Control #

The purpose of this study is to evaluate the safety and efficacy of each of 2 dosages of BOTOX® (200 U or 300 U) compared to placebo injected into the bladder for the treatment of urinary incontinence (leakage) caused by neurogenic detrusor overactivity (overactive bladder from nerve damage or disease) in patients who have not been adequately managed with anticholinergic therapy (bladder relaxing medication).

Title:  A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Repeat Treatment with Two Dose Levels of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by a Treatment with BOTOX® in Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity

Site(s) and/or Type:  Bladder

Principal Investigator:  Patrick J. Shenot, MD

Contact:  Christine Hubert, BA, Clinical Trial Coordinator
(215) 955-9954
Email:  Christine.hubert@jefferson.edu

Criteria:

  • Male or female, between 18 and 80 years of age
  • Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis
  • Inadequate response to anticholinergic medication used to treat overactive bladder
  • No evidence of pelvic or urologic abnormality
  • Not able to temporarily discontinue anti-coagulant medication prior to treatment
  • No previous or current diagnosis of bladder or prostate cancer
  • No urinary tract infection at time of enrollment

Please note that are additional eligibility criteria.  The study center will determine if you meet all of the criteria.

Treatment:

Participants will be randomized into 1 of 4 treatment sequences:

1) BOTOX® 200 U (treatment 1)/BOTOX® 200 U (treatment 2)/ BOTOX® 200 U (treatment 3)

2) BOTOX® 300 U (treatment 1)/BOTOX® 300 U (treatment 2)/ BOTOX® 300 U (treatment 3)

3) Placebo (treatment 1)/Placebo (treatment 2)/ BOTOX® 200 U (treatment 3)

4) Placebo (treatment 1)/Placebo (treatment 2)/ BOTOX® 300 U (treatment 3)

If participants remain eligible for all treatments, then all will receive active BOTOX® treatment at some point during the study.  Urodynamic evaluations, Laboratory evaluations and voiding diary information will be collected throughout the study.

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