Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00681148
Other study ID # IRB00009836
Secondary ID
Status Withdrawn
Phase Phase 2
First received May 19, 2008
Last updated November 19, 2013
Est. completion date July 2012

Study information

Verified date November 2013
Source Emory University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Description:

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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Biopsy proven prostate cancer undergoing brachytherapy

Exclusion Criteria:

- Prior allergic reaction to botulinum toxin

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

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.
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.

Locations

Country Name City State
United States Emory Clinic, Emory University Hospital Atlanta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Emory University

Country where clinical trial is conducted

United States, 

References & Publications (5)

Ansiaux R, Baudelet C, Cron GO, Segers J, Dessy C, Martinive P, De Wever J, Verrax J, Wauthier V, Beghein N, Grégoire V, Buc Calderon P, Feron O, Gallez B. Botulinum toxin potentiates cancer radiotherapy and chemotherapy. Clin Cancer Res. 2006 Feb 15;12(4):1276-83. — View Citation

Chuang YC, Chancellor MB. The application of botulinum toxin in the prostate. J Urol. 2006 Dec;176(6 Pt 1):2375-82. Review. — View Citation

Chuang YC, Huang CC, Kang HY, Chiang PH, Demiguel F, Yoshimura N, Chancellor MB. Novel action of botulinum toxin on the stromal and epithelial components of the prostate gland. J Urol. 2006 Mar;175(3 Pt 1):1158-63. — View Citation

Lee WR, Hall MC, McQuellon RP, Case LD, McCullough DL. A prospective quality-of-life study in men with clinically localized prostate carcinoma treated with radical prostatectomy, external beam radiotherapy, or interstitial brachytherapy. Int J Radiat Oncol Biol Phys. 2001 Nov 1;51(3):614-23. — View Citation

Wallner K, Merrick G, True L, Sutlief S, Cavanagh W, Butler W. 125I versus 103Pd for low-risk prostate cancer: preliminary PSA outcomes from a prospective randomized multicenter trial. Int J Radiat Oncol Biol Phys. 2003 Dec 1;57(5):1297-303. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Urinary symptoms Weekly for 4 weeks, monthly thereafter until 1 year No
Secondary PSA 1 mo, 3 mo, 6 mo, 9 mo, 1 year, 15 mo, 18 mo, 24 mo No
See also
  Status Clinical Trial Phase
Recruiting NCT05613023 - A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT Phase 3
Recruiting NCT05540392 - An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues Phase 1/Phase 2
Recruiting NCT05156424 - A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer Phase 1/Phase 2
Completed NCT03177759 - Living With Prostate Cancer (LPC)
Completed NCT01331083 - A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer Phase 2
Recruiting NCT05540782 - A Study of Cognitive Health in Survivors of Prostate Cancer
Active, not recruiting NCT04742361 - Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer Phase 3
Completed NCT04400656 - PROState Pathway Embedded Comparative Trial
Completed NCT02282644 - Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry N/A
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06305832 - Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer Phase 2
Recruiting NCT05761093 - Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
Completed NCT04838626 - Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection Phase 2/Phase 3
Recruiting NCT03101176 - Multiparametric Ultrasound Imaging in Prostate Cancer N/A
Completed NCT03290417 - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer N/A
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Completed NCT01497925 - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer Phase 1
Recruiting NCT03679819 - Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
Completed NCT03554317 - COMbination of Bipolar Androgen Therapy and Nivolumab Phase 2
Completed NCT03271502 - Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy N/A