Prostate CancerEarly Phase 1NCT01520441
BOTOX in Men With Prostate Cancer With Lower Urinary Tract Symptoms(LUTS)/Benign Prostatic Hyperplasia (BPH)
A Early Phase 1 study testing BOTOX in people with Prostate Cancer and Benign Prostatic Hyperplasia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This is a pilot study examining biological endpoints in men with localized prostate cancer who are scheduled to have radical prostatectomies and men with Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (BPH/LUTS) following botulinum toxin type A (BoNT-A) injection. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostate Cancer, Benign Prostatic Hyperplasia, Enlarged Prostate With Lower Urinary Tract Symptoms (LUTS)
- What is being tested?
- BOTOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Mar 2014
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven, clinically localized prostate cancer
- Low risk for recurrence defined as a Kattan nomogram score of less than 115, or a serum PSA < 10ng/ml, or an individual Gleason grade of 3 or lower, or clinical stage T2b or below.
- Candidates diagnosed with localized prostate cancer must have agreed to radical prostatectomy.
- Voided volume greater than or equal to 125 ml.
- Maximum urinary flow less than 15 ml/sec.
- American Urological Association (AUA) symptom severity score greater than or equal to 8.
- Patient signed informed consent prior to the performance of any study procedures.
- Patient able to complete the study protocol in the opinion of the investigator.
Who cannot join
- Any prior surgical intervention for BPH.
- Current diagnosis of acute or chronic prostatitis (which may cause LUTS that mimic BPH).
- History of bladder stones.
- Overactive bladder without bladder outlet obstruction.
- Enrolled in another treatment trial for any disease within the past 30 days.
- Previous exposure to botulinum toxin.
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- Post void residual greater than 350 ml.
- Clinically significant renal or hepatic impairment as determined by abnormal creatinine or AST levels (based on local institutional values).
- Daily use of a pad or device for incontinence required.
- Episode of unstable angina pectoris, myocardial infarction, transient ischemic attack, or cerebrovascular accident (stroke) within the past 6 months.
- On aminoglycosides or any drug that interfere with neuromuscular transmission.
- Eaton-Lambert syndrome, hemophilia, hereditary clotting factors deficiency, or bleeding diathesis.
- Penile prosthesis or artificial urinary sphincter.
- History or current evidence of carcinoma of the bladder; pelvic radiation, hormonal treatment or surgery; urethral stricture; or bladder neck obstruction.
- Known primary neurologic conditions such as multiple sclerosis, myasthenia gravis or Parkinson's disease, or other neurological diseases known to affect bladder function.
- Two documented urinary tract infections of any type in the past year (UTI defined as greater than 100,000 colonies per ml urine from midstream clean catch or catheterized specimen).
- Patients must be off aspirin, non-steroidal anti-inflammatory drugs (NSAIDS), and Coumadin for 7 or more days prior to botulinum toxin injection.
- Any serious medical condition likely to impede successful completion of the study, such as certain mental disorders, hypersensitivity to botulinum toxin or anesthetics used in the study, syncope, uncontrolled diabetes.
- Patients will be excluded if they have depressed hematopoietic functions (platelet count <100,000/cm3, hemoglobin <8,5 mg/dl; absolute neutrophil count <1000/cm3).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Houston - Medical School
Houston, Texas, 77030
About this study
Official title: H-25362: Effect of Botulinum Neurotoxin Type A Prostate Injections on Neurogenesis and Gene Profile Expression in Men With Localized Prostate Cancer and Lower Urinary Tract Symptoms/BPH (Protocol # 05-09-30-03)
This is a pilot study examining biological endpoints in men with localized prostate cancer who are scheduled to have radical prostatectomies and men with Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (BPH/LUTS) following botulinum toxin type A (BoNT-A) injection. Patients will serve as their own controls by receiving BoNT-A injections into the right peripheral and transition zones and sham saline injections into the left peripheral and transition zones.
Read the detailed description
For the purposes of this study, patients are treated with the presentation of botulinum toxin type A which is marketed in the U.S. as BOTOX® by Allergan. BOTOX® is a purified neurotoxin complex supplied as a sterile, vacuum dried purified botulinum toxin type A, produced from fermentation of Clostridium botulinum type A.
A primary aim of this study is to determine the molecular effects of BoNT-A injection on human BPH tissues. While the majority of BoNT-A injections in humans target BPH in the transition zone, innervation is most abundant in the peripheral zone of the prostate where the majority of prostate cancers develop. In fact, recent studies have demonstrated the importance of neurogenesis and axogenesis in the spread of human prostate cancer. In addition, in vitro studies have shown that BoNT-A has antiproliferative effects on human prostate cancer cell lines.
Thus, a second aim of this proposal is to determine profile changes in high-grade prostatic intraepithelial neoplasia (HGPIN) and prostate cancer following BoNT-A injection into the peripheral zone. The investigators will also determine the effects of BoNT-A on the genetic profile of normal tissue. The investigators study population will be men with clinically localized prostate cancer. Men will be injected on one side in both their transition and peripheral zones with 100U BoNT-A (i.e. Botox®, Allergan, Inc.), respectively, one month prior to their scheduled radical prostatectomy. Sham saline injection of the other side of the prostate (transition and peripheral zones) will be used as an internal control. The investigators will inject the other lobe of the prostate with saline to account for any denervating effects of "wet needling." Patients will undergo radical prostatectomy without any changes to standard of care. The strategy has been used in the investigators Institution previously to determine the efficacy of gene therapy 22 and targeted drugs. However, and unlike the investigators previous neoadjuvant trials, the investigators will not power this study to look at the effects of Botox on biochemical recurrence free survival. This study only has biologic endpoints and no survival endpoints."
A third aim of the study will be to examine changes in vas deferens function following prostate treatment with BoNT-A. The investigators plan to harvest a 2.5 cm segment from the distal vas deferens on either side (i.e. Saline treated and BoNT-A treated) before entry into the prostate will be isolated and placed in oxygenated krebs solution for transport to the research laboratory.
Patients will have 3 visits to the clinic and two telephone calls during their participation in this study. The last visit is about 4 weeks after the injection.
- Conditions
- Prostate Cancer, Benign Prostatic Hyperplasia, Enlarged Prostate With Lower Urinary Tract Symptoms (LUTS)
- Being tested
- BOTOX
- Keywords
- Botulinum Toxin, Prostate Cancer, BPH, LUTS
- Medical subject headings
- Prostatic Neoplasms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOTOXDrug
Also called onabotulinumtoxinA
A total of 200 units of BoNT-A diluted in 4ml of preservative free saline will be injected into the right prostate lobe (i.e. transition and peripheral zones). A similar injection template with 1.0ml volume injections of saline will be injected into the left prostate lobe (2 injections in transition zone, 2 injections in peripheral zone for total volume of 4ml).
| Study group | Role | What they receive |
|---|---|---|
| BOTOX Injection | Experimental | A total of 200 units of BoNT-A diluted in 4ml of preservative free saline will be injected into the right prostate lobe (i.e. transition and peripheral zones). A similar injection template with 1.0ml volume injections of saline will be injected into the left prostate lobe (2 injections in transition zone, 2 injections in peripheral zone for total volume of 4ml). Receives: Drug: BOTOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination the effects of BoNT-A injection on BPH and prostate cancer tissues.
The prostate tissue taken from each lobe will be compared to determine if the injection of BOTOX has effected the genetic profile.
Measured: 3 years
Secondary outcomes (1)
Determination of BOTOX prostate injection on vas deferens tissue
Any changes to the vas deferens tissue after BOTOX injection, will be noted.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startMar 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gustavo Ayala, The University of Texas Health Science Center, Houston
- Investigators
- Gusatavo E. Ayala, MD, Principal investigator, University of Texas Houston Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520441
- Sponsor's protocol ID
- H-25362
- Status last verified
- Jun 2015
- First submitted
- 24 Jan 2012
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chancellor MB, Smith CP: Botulinum Toxin in Urology. First Edition. New York: Springer, Aug 2011. (Book)
Smith CP. Botulinum toxin in the treatment of OAB, BPH, and IC. Toxicon. 2009 Oct;54(5):639-46. doi: 10.1016/j.toxicon.2009.02.021. Epub 2009 Mar 4.
PubMed 19268490Crawford ED, Hirst K, Kusek JW, Donnell RF, Kaplan SA, McVary KT, Mynderse LA, Roehrborn CG, Smith CP, Bruskewitz R. Effects of 100 and 300 units of onabotulinum toxin A on lower urinary tract symptoms of benign prostatic hyperplasia: a phase II randomized clinical trial. J Urol. 2011 Sep;186(3):965-70. doi: 10.1016/j.juro.2011.04.062. Epub 2011 Jul 24.
PubMed 21791356
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- H-25362: Effect of Botulinum Neurotoxin Type A Prostate Injections on Neurogenesis and Gene Profile Expression in Men With Localized Prostate Cancer and Lower Urinary Tract Symptoms/BPH (Protocol # 05-09-30-03)
- ClinicalTrials.gov ID
- NCT01520441
- Acronym / sponsor ID
- H-25362
- Conditions
- Prostate Cancer, Benign Prostatic Hyperplasia, Enlarged Prostate With Lower Urinary Tract Symptoms (LUTS)
- Keywords
- Botulinum Toxin, Prostate Cancer, BPH, LUTS
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study examining biological endpoints in men with localized prostate cancer who are scheduled to have radical prostatectomies and men with Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (BPH/LUTS) following botulinum toxin type A (BoNT-A) injection. Patients will serve as their own controls by receiving BoNT-A injections into the right peripheral and transition zones and sham saline injections into the left peripheral and transition zones.
Detailed description
For the purposes of this study, patients are treated with the presentation of botulinum toxin type A which is marketed in the U.S. as BOTOX® by Allergan. BOTOX® is a purified neurotoxin complex supplied as a sterile, vacuum dried purified botulinum toxin type A, produced from fermentation of Clostridium botulinum type A.
A primary aim of this study is to determine the molecular effects of BoNT-A injection on human BPH tissues. While the majority of BoNT-A injections in humans target BPH in the transition zone, innervation is most abundant in the peripheral zone of the prostate where the majority of prostate cancers develop. In fact, recent studies have demonstrated the importance of neurogenesis and axogenesis in the spread of human prostate cancer. In addition, in vitro studies have shown that BoNT-A has antiproliferative effects on human prostate cancer cell lines.
Thus, a second aim of this proposal is to determine profile changes in high-grade prostatic intraepithelial neoplasia (HGPIN) and prostate cancer following BoNT-A injection into the peripheral zone. The investigators will also determine the effects of BoNT-A on the genetic profile of normal tissue. The investigators study population will be men with clinically localized prostate cancer. Men will be injected on one side in both their transition and peripheral zones with 100U BoNT-A (i.e. Botox®, Allergan, Inc.), respectively, one month prior to their scheduled radical prostatectomy. Sham saline injection of the other side of the prostate (transition and peripheral zones) will be used as an internal control. The investigators will inject the other lobe of the prostate with saline to account for any denervating effects of "wet needling." Patients will undergo radical prostatectomy without any changes to standard of care. The strategy has been used in the investigators Institution previously to determine the efficacy of gene therapy 22 and targeted drugs. However, and unlike the investigators previous neoadjuvant trials, the investigators will not power this study to look at the effects of Botox on biochemical recurrence free survival. This study only has biologic endpoints and no survival endpoints."
A third aim of the study will be to examine changes in vas deferens function following prostate treatment with BoNT-A. The investigators plan to harvest a 2.5 cm segment from the distal vas deferens on either side (i.e. Saline treated and BoNT-A treated) before entry into the prostate will be isolated and placed in oxygenated krebs solution for transport to the research laboratory.
Patients will have 3 visits to the clinic and two telephone calls during their participation in this study. The last visit is about 4 weeks after the injection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BOTOX Injection | Experimental | Drug: BOTOXA total of 200 units of BoNT-A diluted in 4ml of preservative free saline will be injected into the right prostate lobe (i.e. transition and peripheral zones). A similar injection template with 1.0ml volume injections of saline will be injected into the left prostate lobe (2 injections in transition zone, 2 injections in peripheral zone for total volume of 4ml). |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Biopsy proven, clinically localized prostate cancer
- Low risk for recurrence defined as a Kattan nomogram score of less than 115, or a serum PSA < 10ng/ml, or an individual Gleason grade of 3 or lower, or clinical stage T2b or below.
- Candidates diagnosed with localized prostate cancer must have agreed to radical prostatectomy.
- Voided volume greater than or equal to 125 ml.
- Maximum urinary flow less than 15 ml/sec.
Key exclusion criteria (19 listed)
- Any prior surgical intervention for BPH.
- Current diagnosis of acute or chronic prostatitis (which may cause LUTS that mimic BPH).
- History of bladder stones.
- Overactive bladder without bladder outlet obstruction.
- Enrolled in another treatment trial for any disease within the past 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BOTOXAlso: onabotulinumtoxinAA total of 200 units of BoNT-A diluted in 4ml of preservative free saline will be injected into the right prostate lobe (i.e. transition and peripheral zones). A similar injection template with 1.0ml volume injections of saline will be injected into the left prostate lobe (2 injections in transition zone, 2 injections in peripheral zone for total volume of 4ml). | Drug | BOTOX Injection |
Primary outcome
Determination the effects of BoNT-A injection on BPH and prostate cancer tissues.
Time frame: 3 years
The prostate tissue taken from each lobe will be compared to determine if the injection of BOTOX has effected the genetic profile.
1 secondary outcome
Determination of BOTOX prostate injection on vas deferens tissue
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- BackgroundChancellor MB, Smith CP: Botulinum Toxin in Urology. First Edition. New York: Springer, Aug 2011. (Book)
- Background: PubMed 19268490Smith CP. Botulinum toxin in the treatment of OAB, BPH, and IC. Toxicon. 2009 Oct;54(5):639-46. doi: 10.1016/j.toxicon.2009.02.021. Epub 2009 Mar 4.
- Background: PubMed 21791356Crawford ED, Hirst K, Kusek JW, Donnell RF, Kaplan SA, McVary KT, Mynderse LA, Roehrborn CG, Smith CP, Bruskewitz R. Effects of 100 and 300 units of onabotulinum toxin A on lower urinary tract symptoms of benign prostatic hyperplasia: a phase II randomized clinical trial. J Urol. 2011 Sep;186(3):965-70. doi: 10.1016/j.juro.2011.04.062. Epub 2011 Jul 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gusatavo E. Ayala, MD principal investigator
University of Texas Houston Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BOTOX in people with Prostate Cancer and Benign Prostatic Hyperplasia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination the effects of BoNT-A injection on BPH and prostate cancer tissues. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01520441, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.