Clinical trial · Interventional
Botulinum Toxin Injection With Prostate Brachytherapy
Botulinum Toxin Injection With Prostate Brachytherapy: A Randomized, Placebo-controlled Study Monitoring Urinary Symptoms and PSA
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No funding
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lower Urinary Tract Symptoms | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Radioactive Seed Implantation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Botox injection | Drug | — | UNRESOLVED |
| Saline injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Botox injection
- interventionNames
- Drug: Botox injection
- type
- PLACEBO_COMPARATOR
- label
- B
- description
- Saline injection
- interventionNames
- Drug: Saline injection
Primary outcomes (1)
- measure
- Urinary symptoms
- timeFrame
- Weekly for 4 weeks, monthly thereafter until 1 year
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven prostate cancer undergoing brachytherapy Exclusion Criteria: * Prior allergic reaction to botulinum toxin
References
Publications (5)
- BACKGROUNDLee 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. doi: 10.1016/s0360-3016(01)01707-2. PMID 11597800
- BACKGROUNDWallner 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. doi: 10.1016/s0360-3016(03)01448-2. PMID 14630265
- BACKGROUNDAnsiaux R, Baudelet C, Cron GO, Segers J, Dessy C, Martinive P, De Wever J, Verrax J, Wauthier V, Beghein N, Gregoire 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. doi: 10.1158/1078-0432.CCR-05-1222. PMID 16489084
- BACKGROUNDChuang YC, Chancellor MB. The application of botulinum toxin in the prostate. J Urol. 2006 Dec;176(6 Pt 1):2375-82. doi: 10.1016/j.juro.2006.07.127. PMID 17085104
- BACKGROUNDChuang 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. doi: 10.1016/S0022-5347(05)00318-6. PMID 16469644