Prostate CancerPhase 1/2NCT07796490
Neoadjuvant Intraprostatic OnabotulinumtoxinA Before Radical Prostatectomy for High-Risk Localized Prostate Cancer
A Phase 1/2 study testing OnabotulinumtoxinA (BOTOX®) in people with Prostate Cancer, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
This pilot randomized, single-blind, placebo-controlled study evaluates the feasibility, safety, and preliminary biological activity of neoadjuvant intraprostatic onabotulinumtoxinA (BOTOX®) administered before radical prostatectomy in men with high-risk localized prostate cancer. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- OnabotulinumtoxinA (BOTOX®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Nov 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, ≥ 45 years
- Histologically confirmed prostate adenocarcinoma
- Gleason score ≥8 on biopsy
- Candidate for and scheduled to undergo RALP for primary treatment
- ECOG 0-2
- Able to read, speak, and understand English
- Able to provide informed consent
Who cannot join
- Prior prostate cancer therapy (radiation, ADT, chemotherapy)
- Metastatic disease
- Known hypersensitivity to botulinum toxin
- Neuromuscular disorders (e.g., myasthenia gravis)
- Active infection, coagulopathy, or contraindication to transperineal injection
- Medications significantly affecting neuromuscular transmission (clinically relevant)
- Any condition compromising safety or protocol compliance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Pilot Randomized, Single Blind, Placebo Controlled Study of Neoadjuvant Intraprostatic OnabotulinumtoxinA Prior to Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer
This pilot randomized, single-blind, placebo-controlled study evaluates the feasibility, safety, and preliminary biological activity of neoadjuvant intraprostatic onabotulinumtoxinA (BOTOX®) administered before radical prostatectomy in men with high-risk localized prostate cancer. Thirty participants will be randomized 1:1 to receive a single transrectal ultrasound-guided intraprostatic injection of onabotulinumtoxinA (50 units) or placebo 6 to 8 weeks before surgery. Outcomes include feasibility metrics, safety, adverse events, pathological findings at prostatectomy, and postoperative prostate-specific antigen (PSA) levels
Read the detailed description
High-risk localized prostate cancer is associated with a substantial risk of adverse pathological features and disease recurrence despite definitive treatment with radical prostatectomy. Emerging evidence suggests that neural signaling within the prostate tumor microenvironment contributes to tumor growth, progression, and treatment resistance. OnabotulinumtoxinA (BOTOX®), a neurotoxin that blocks acetylcholine release, has demonstrated biological effects in prostate tissue and may provide a novel approach to modulating tumor-associated neural pathways.
This single-center, prospective, randomized, single-blind, placebo-controlled pilot study will enroll 30 men with high-risk or very-high-risk localized prostate adenocarcinoma who are scheduled to undergo radical prostatectomy. Participants will be randomized in a 1:1 ratio to receive either a single transrectal ultrasound-guided intraprostatic injection of onabotulinumtoxinA (50 units) or an equivalent-volume normal saline placebo 6 to 8 weeks prior to surgery. Participants will remain blinded to treatment assignment.
The primary objective is to evaluate study feasibility and safety, including participant accrual, protocol adherence, successful completion of intraprostatic injection and planned surgery, and the incidence and severity of adverse events. Secondary objectives include evaluation of pathological outcomes at prostatectomy, including Gleason score, perineural invasion, stromogenic component, tumor burden, pathological stage, and surgical margin status. Early postoperative PSA outcomes will also be assessed. Exploratory analyses will evaluate time to biochemical recurrence following radical prostatectomy.
This pilot study is not powered to demonstrate clinical efficacy. Instead, it is designed to establish the safety and feasibility of neoadjuvant intraprostatic onabotulinumtoxinA and generate preliminary biological and pathological data to support future studies investigating neural modulation as a therapeutic strategy in prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- OnabotulinumtoxinA (BOTOX®), Normal Saline Placebo
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinA (BOTOX®)Drug
Also called Botox
A single transperineal, transrectal ultrasound (TRUS)-guided intraprostatic injection of onabotulinumtoxinA, total dose 50 units, administered 6 to 8 weeks prior to radical prostatectomy.
Normal Saline PlaceboOther
Participants randomized to the placebo arm will receive a single transperineal, transrectal ultrasound (TRUS)-guided intraprostatic injection of normal saline administered in an identical volume and injection pattern as the active treatment arm, 6 to 8 weeks prior to planned radical prostatectomy.
| Study group | Role | What they receive |
|---|---|---|
| Botox | Experimental | A single transperineal, transrectal ultrasound (TRUS)-guided intraprostatic injection of onabotulinumtoxinA, total dose 50 units, administered 6 to 8 weeks prior to radical prostatectomy. Receives: Drug: OnabotulinumtoxinA (BOTOX®) |
| Placebo | Placebo comparator | A single transperineal, transrectal ultrasound (TRUS)-guided intraprostatic injection of normal saline placebo administered in an identical volume and injection pattern 6 to 8 weeks prior to radical prostatectomy. Receives: Other: Normal Saline Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Accrural
Number of participants enrolled in the study
Measured: Through study completion, an average of 1 year
Protocol Adherence
Proportion of participants who complete study procedures according to protocol requirements.
Measured: Through study completion, an average of 1 year
Successful Completion of Intraprostatic Injection
Number of participants who successfully receive the assigned intraprostatic study injection.
Measured: At time of surgery
Incidence of Adverse Events
Incidence, severity, seriousness, and relationship of adverse events associated with intraprostatic administration of onabotulinumtoxinA or placebo.
Measured: From study injection through 36 months of follow-up.
Successful Completion of Planned Radical Prostatectomy
Proportion of participants who undergo planned radical prostatectomy following study intervention without study-related cancellation or unacceptable delay.
Measured: Within 6 to 8 weeks after intraprostatic injection.
Secondary outcomes (6)
Gleason Score at Radical Prostatectomy
Comparison of Gleason score determined from radical prostatectomy specimens between treatment arms.
Gleason Score determined from radical prostatectomy specimens. Gleason Scores range from 6 to 10, with higher scores indicating more aggressive prostate cancer.
Measured: At radical prostatectomy (6 to 8 weeks after study injection).
Perineural Invasion
Presence and extent of perineural invasion identified in radical prostatectomy specimens.
Measured: At radical prostatectomy (6 to 8 weeks after study injection).
Stromogenic Component
Assessment of stromogenic component in radical prostatectomy specimens.
Measured: At radical prostatectomy (6 to 8 weeks after study injection).
Tumor Size
Tumor size measured in radical prostatectomy specimens. The measurement will be recorded in centimeters (cm).
Measured: At radical prostatectomy (6 to 8 weeks after study injection).
Positive Surgical Margin Status
Proportion of participants with positive surgical margins following radical prostatectomy.
Measured: At radical prostatectomy (6 to 8 weeks after study injection).
Postoperative Prostate-Specific Antigen (PSA)
Serum PSA levels following radical prostatectomy.
Measured: 6 to 8 weeks after radical prostatectomy and during follow-up through 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to receive either a single intraprostatic injection of onabotulinumtoxinA (50 units) or placebo (normal saline) administered 6 to 8 weeks prior to radical prostatectomy. Participants remain in their assigned treatment group throughout the study, and outcomes are compared between parallel treatment arms.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Miles, The Methodist Hospital Research Institute
- Investigators
- Brian Miles, MD, Principal investigator, Houston Methodist Urology, Houston Methodist Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796490
- Sponsor's protocol ID
- Pro00046310
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized, Single Blind, Placebo Controlled Study of Neoadjuvant Intraprostatic OnabotulinumtoxinA Prior to Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT07796490
- Acronym / sponsor ID
- Pro00046310
- Conditions
- Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 1 Sep 2026 (actual)
- 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 pilot randomized, single-blind, placebo-controlled study evaluates the feasibility, safety, and preliminary biological activity of neoadjuvant intraprostatic onabotulinumtoxinA (BOTOX®) administered before radical prostatectomy in men with high-risk localized prostate cancer. Thirty participants will be randomized 1:1 to receive a single transrectal ultrasound-guided intraprostatic injection of onabotulinumtoxinA (50 units) or placebo 6 to 8 weeks before surgery. Outcomes include feasibility metrics, safety, adverse events, pathological findings at prostatectomy, and postoperative prostate-specific antigen (PSA) levels
Detailed description
High-risk localized prostate cancer is associated with a substantial risk of adverse pathological features and disease recurrence despite definitive treatment with radical prostatectomy. Emerging evidence suggests that neural signaling within the prostate tumor microenvironment contributes to tumor growth, progression, and treatment resistance. OnabotulinumtoxinA (BOTOX®), a neurotoxin that blocks acetylcholine release, has demonstrated biological effects in prostate tissue and may provide a novel approach to modulating tumor-associated neural pathways.
This single-center, prospective, randomized, single-blind, placebo-controlled pilot study will enroll 30 men with high-risk or very-high-risk localized prostate adenocarcinoma who are scheduled to undergo radical prostatectomy. Participants will be randomized in a 1:1 ratio to receive either a single transrectal ultrasound-guided intraprostatic injection of onabotulinumtoxinA (50 units) or an equivalent-volume normal saline placebo 6 to 8 weeks prior to surgery. Participants will remain blinded to treatment assignment.
The primary objective is to evaluate study feasibility and safety, including participant accrual, protocol adherence, successful completion of intraprostatic injection and planned surgery, and the incidence and severity of adverse events. Secondary objectives include evaluation of pathological outcomes at prostatectomy, including Gleason score, perineural invasion, stromogenic component, tumor burden, pathological stage, and surgical margin status. Early postoperative PSA outcomes will also be assessed. Exploratory analyses will evaluate time to biochemical recurrence following radical prostatectomy.
This pilot study is not powered to demonstrate clinical efficacy. Instead, it is designed to establish the safety and feasibility of neoadjuvant intraprostatic onabotulinumtoxinA and generate preliminary biological and pathological data to support future studies investigating neural modulation as a therapeutic strategy in prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive either a single intraprostatic injection of onabotulinumtoxinA (50 units) or placebo (normal saline) administered 6 to 8 weeks prior to radical prostatectomy. Participants remain in their assigned treatment group throughout the study, and outcomes are compared between parallel treatment arms.
| Arm | Type | Receives |
|---|---|---|
| Botox | Experimental | Drug: OnabotulinumtoxinA (BOTOX®)A single transperineal, transrectal ultrasound (TRUS)-guided intraprostatic injection of onabotulinumtoxinA, total dose 50 units, administered 6 to 8 weeks prior to radical prostatectomy. |
| Placebo | Placebo comparator | Other: Normal Saline PlaceboA single transperineal, transrectal ultrasound (TRUS)-guided intraprostatic injection of normal saline placebo administered in an identical volume and injection pattern 6 to 8 weeks prior to radical prostatectomy. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male, ≥ 45 years
- Histologically confirmed prostate adenocarcinoma
- Gleason score ≥8 on biopsy
- Candidate for and scheduled to undergo RALP for primary treatment
- ECOG 0-2
Key exclusion criteria (7 listed)
- Prior prostate cancer therapy (radiation, ADT, chemotherapy)
- Metastatic disease
- Known hypersensitivity to botulinum toxin
- Neuromuscular disorders (e.g., myasthenia gravis)
- Active infection, coagulopathy, or contraindication to transperineal injection
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 |
|---|---|---|
| OnabotulinumtoxinA (BOTOX®)Also: BotoxA single transperineal, transrectal ultrasound (TRUS)-guided intraprostatic injection of onabotulinumtoxinA, total dose 50 units, administered 6 to 8 weeks prior to radical prostatectomy. | Drug | Botox |
| Normal Saline PlaceboParticipants randomized to the placebo arm will receive a single transperineal, transrectal ultrasound (TRUS)-guided intraprostatic injection of normal saline administered in an identical volume and injection pattern as the active treatment arm, 6 to 8 weeks prior to planned radical prostatectomy. | Other | Placebo |
Primary outcome
Participant Accrural
Time frame: Through study completion, an average of 1 year
Number of participants enrolled in the study
Protocol Adherence
Time frame: Through study completion, an average of 1 year
Proportion of participants who complete study procedures according to protocol requirements.
Successful Completion of Intraprostatic Injection
Time frame: At time of surgery
Number of participants who successfully receive the assigned intraprostatic study injection.
Incidence of Adverse Events
Time frame: From study injection through 36 months of follow-up.
Incidence, severity, seriousness, and relationship of adverse events associated with intraprostatic administration of onabotulinumtoxinA or placebo.
Successful Completion of Planned Radical Prostatectomy
Time frame: Within 6 to 8 weeks after intraprostatic injection.
Proportion of participants who undergo planned radical prostatectomy following study intervention without study-related cancellation or unacceptable delay.
6 secondary outcomes
Gleason Score at Radical Prostatectomy
Time frame: At radical prostatectomy (6 to 8 weeks after study injection).
Perineural Invasion
Time frame: At radical prostatectomy (6 to 8 weeks after study injection).
Stromogenic Component
Time frame: At radical prostatectomy (6 to 8 weeks after study injection).
Tumor Size
Time frame: At radical prostatectomy (6 to 8 weeks after study injection).
Positive Surgical Margin Status
Time frame: At radical prostatectomy (6 to 8 weeks after study injection).
Postoperative Prostate-Specific Antigen (PSA)
Time frame: 6 to 8 weeks after radical prostatectomy and during follow-up through 36 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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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.
Brian Miles, MD principal investigator
Houston Methodist Urology, Houston Methodist Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing OnabotulinumtoxinA (BOTOX®) in people with Prostate Cancer, run by The Methodist Hospital Research Institute 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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 2 Sep 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vivian MacDonnell, MD (7134928703, vmmacdonnell@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Accrural (time frame: Through study completion, an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2026.