Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Emory University |
---|---|
Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00681148 |
The purpose of this study is to see if botox injection into the prostate during seed implantation (brachytherapy) for prostate cancer a) improves urinary symptoms or avoids need for urinary tract instrumentation over the 6-8 month post-operative period when one wants to avoid manipulating the radioactive seeds, and b) speeds up the drop in PSA. Patients will be randomized to botox vs saline injection, at the completion of the seed implantation procedure.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer Lower Urinary Tract Symptoms Radioactive Seed Implantation |
Drug: Botox injection Drug: Saline injection |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
Official Title: | Botulinum Toxin Injection With Prostate Brachytherapy: A Randomized, Placebo-Controlled Study Monitoring Urinary Symptoms and PSA |
Estimated Enrollment: | 60 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | July 2012 |
Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Botox injection
|
Drug: Botox injection
Intraprostatic injection of Botox (100 units for < 30 cc prostate; 200 units for > 30 cc prostate) administering 2 transperineal injections into both lateral lobes of the prostate (25-50 units per injection), just 5-10 mm proximal to the bladder neck.
|
B: Placebo Comparator
Saline injection
|
Drug: Saline injection
Saline injection, administering 2 transperineal injections into both lateral lobes of the prostate (1-2 cc per injection), just 5-10 mm proximal to the bladder neck.
|
Brachytherapy is a popular treatment modality for localized prostate cancer, where radioactive seeds are implanted through 18 gauge needles into the prostate via a perineal template with rectal ultrasound guidance. The radioactivity is delivered over several months, depending on the isotope used. During this time, there can be exacerbation of urinary voiding symptoms from early edema of the prostate gland due to the implantation procedure, then later from the inflammatory reaction of the radiation. Because the initial acute inflammation may persist for many months despite steadily declining doses of radiation, attempts are made to minimize urinary symptoms prior to brachytherapy with pharmacologic therapy (alpha-blockers) or minimally invasive surgical therapy (transurethral incision or limited transurethral resection to avoid significant distortion of the prostate parenchyma for future seed implantation). Even with these precautions, around 30-40% of brachytherapy patients will still develop voiding symptoms. With such bothersome symptoms, intervention is deferred for at least 8-10 months to avoid distorting the planned field of radiation. Once symptoms develop, various additional pharmacologic measures are employed, such as increased doses of alpha-blockers, medrol steroid taper, and non-steroidal anti-inflammatory agents. Some patients require intermittent self-catheterization or suprapubic catheter for urinary diversion.
Botulinum toxin has been used for cosmetic uses, and has been successfully used for treatment of overactive bladder, external sphincter dyssynergia, and benign prostatic hyperplasia (BPH). The studies with BPH show reduction in symptoms scores, PSA, and prostate volume, the latter from atrophy due to the denervation effect. The response lasts for 6-9 months.
We propose to study botox intraprostatic injection during brachytherapy to see whether this improves urinary symptoms or avoids need for urinary tract instrumentation over this 6-8 month post-operative period when one wants to avoid manipulating the radioactive seeds. We will also monitor PSA, and see if there is any measurable augmentation of PSA decline with botox + Brachytherapy vs Brachytherapy alone. We will randomize patients to botox (100 units for < 30 cc prostate; 200 units for > 30 cc prostate) vs saline injection, administering 2 transperineal injections into both lateral lobes of the prostate (25-50 mg per injection), just 5-10 mm proximal to the bladder neck.
Study design:
N= 60 (30 receive Botox, 30 receive saline)
Followup:
AUA Symptoms scores weekly for 4 weeks, monthly thereafter Medications for urinary symptoms Need for catheterization PSA checked at 1 mo, 3 mo, 6 mo, 9 mo, 1 year, 15 mo, 18 mo, 24 mo
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Peter T Nieh, MD | 404-778-4898 | peter.nieh@emoryhealthcare.org |
United States, Georgia | |
Emory Clinic, Emory University Hospital | |
Atlanta, Georgia, United States, 30322 |
Principal Investigator: | Peter T Nieh, MD | Emory University SOM |
Responsible Party: | Emory University ( Peter T. Nieh, MD ) |
Study ID Numbers: | IRB0009836 |
Study First Received: | May 19, 2008 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00681148 |
Health Authority: | United States: Institutional Review Board |
Prostate specific antigen (PSA) Prostate cancer Lower urinary tract symptoms Radioactive seed implantation |
Botulinum Toxins Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Botulinum Toxin Type A Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Anti-Dyskinesia Agents Therapeutic Uses Physiological Effects of Drugs |
Neuromuscular Agents Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions |