PROSTATE CANCERPhase 1NCT07100847
Periprostatic Neurolysis in Prostate Cancer
A Phase 1 study testing Periprostatic neurolysis with dehydrated alcohol (ethanol) in people with PROSTATE CANCER and NERVES, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this research study is to assess whether inhibiting nerve activity to the prostate delays progression of disease in men with high-risk clinical features for prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- PROSTATE CANCER, NERVES, NEUROBIOLOGY OF CANCER
- What is being tested?
- Periprostatic neurolysis with dehydrated alcohol (ethanol)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2025to Aug 2028
- Phase
- Phase 1
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High risk prostate cancer as defined by NCCN criteria Desires surgical disease treatment (radical prostatectomy) Surgical candidate (for radical prostatectomy)
- ≤cT3a on MRI No seminal vesicle, lymph node, or metastatic disease on PSMA PET No prior prostate cancer treatment (including androgen deprivation therapy, radiation therapy, focal therapy, cryo therapy)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Phase 1b Window of Opportunity Study of Peri-prostatic Neurolysis in High-risk Localized Prostate Cancer
The purpose of this research study is to assess whether inhibiting nerve activity to the prostate delays progression of disease in men with high-risk clinical features for prostate cancer. Prostate cancer has been shown to invade nerves, a mechanism that is thought to be involved in prostate cancer spread in men with high-risk cancer. When nerve activity to the prostate is blocked in mice with prostate cancer, prostate cancer growth and spread are inhibited. In a previous study we showed that doing so in humans was safe and may have anticancer therapeutic effect. In this study we will test whether one versus two injections of nerve blocking agent is more effective at reducing nerves in the prostate and whether it will slow/stop spread of prostate cancer after treatment.
Read the detailed description
Men with high-risk prostate cancer are at the greatest risk for clinical progression, with 22 to 40% developing metastatic disease within 10 years of initial treatment. Furthermore, the finding of perineural invasion (PNI) on pathology (when prostate cancer cells invade the nerves that innervate the prostate), is associated with higher Gleason grades and an approximate doubling in risk of lethal prostate cancer. As 90% of prostate cancer metastasis involve the bone marrow, and 97% of bone marrow metastasis involve the lumbar vertebrate from which the pre-ganglionic sympathetic nerves that innervate the prostate derive, targeting this neuro-anatomic connection between the prostate and its primary site of metastasis is an active area of investigation. Therefore, development of therapeutic strategies targeting nerves to prevent clinical progression after definitive therapy for prostate cancer are urgently needed. In a Phase 1a dose escalation study (NCT06703437) we recently demonstrated that periprostatic neurolysis with 5mL pure ethanol was well tolerated with no AEs. This resulted in an approximate 30% reduction in prostatic adrenergic nerve density. The goal of this study is to optimize prostatic denervation by comparing the denervation efficiency of 1 vs 2 periprostatic ethanol injections.
- Conditions
- PROSTATE CANCER, NERVES, NEUROBIOLOGY OF CANCER, NEUROLYSIS
- Being tested
- Periprostatic neurolysis with dehydrated alcohol (ethanol)
- Keywords
- HIGH RISK LOCALIZED PROSTATE CANCER
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periprostatic neurolysis with dehydrated alcohol (ethanol)Procedure or surgery
Pre-operative ultrasound guided periprostatic neurolysis by injection of dehydrated alcohol
| Study group | Role | What they receive |
|---|---|---|
| Single injection neurolysis | Experimental | Single injection of ethanol for periprostatic neurolysis Receives: Procedure: Periprostatic neurolysis with dehydrated alcohol (ethanol) |
| Two injection neurolysis | Experimental | Two temporally separated periprostatic ethanol injections Receives: Procedure: Periprostatic neurolysis with dehydrated alcohol (ethanol) |
| No injection control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peritumoral adrenergic nerve density on final histology
Will quantify degree of neurolysis by measuring decrease in adrenergic nerve density on radical prostatectomy specimen histology
Measured: 4 to 6 weeks after treatment initiation
Secondary outcomes (3)
Change in sexual health inventory for men (SHIM) score
Change in erectile function as measured by SHIM score at enrollment and 4 to 6 weeks after periprostatic neurolysis
Measured: 4 to 6 weeks after intervention
Change in International Prostate Symptom Score (IPSS)
Change in lower urinary tract symptoms as measured by IPSS questionnaire at baseline and after neurolysis
Measured: 4 to 6 weeks after intervention
Change in post prostatectomy penile length
Change in penile length post prostatectomy compared to baseline
Measured: 6months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start15 Aug 2025
- Primary completionJul 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PROSTATE CANCERStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Urology Care Foundation, American Urological Association
- Responsible party
- Principal investigator, Ali Zahalka, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100847
- Sponsor's protocol ID
- STU20240058
- Status last verified
- Sep 2026
- First submitted
- 27 Jul 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available.
Publications
Zahalka AH, Arnal-Estape A, Maryanovich M, Nakahara F, Cruz CD, Finley LWS, Frenette PS. Adrenergic nerves activate an angio-metabolic switch in prostate cancer. Science. 2017 Oct 20;358(6361):321-326. doi: 10.1126/science.aah5072.
PubMed 29051371
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Window of Opportunity Study of Peri-prostatic Neurolysis in High-risk Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT07100847
- Acronym / sponsor ID
- STU20240058
- Conditions
- PROSTATE CANCER, NERVES, NEUROBIOLOGY OF CANCER, NEUROLYSIS
- Keywords
- HIGH RISK LOCALIZED PROSTATE CANCER
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Urology Care Foundation, American Urological Association
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 3 Aug 2025 (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.
The purpose of this research study is to assess whether inhibiting nerve activity to the prostate delays progression of disease in men with high-risk clinical features for prostate cancer. Prostate cancer has been shown to invade nerves, a mechanism that is thought to be involved in prostate cancer spread in men with high-risk cancer. When nerve activity to the prostate is blocked in mice with prostate cancer, prostate cancer growth and spread are inhibited. In a previous study we showed that doing so in humans was safe and may have anticancer therapeutic effect. In this study we will test whether one versus two injections of nerve blocking agent is more effective at reducing nerves in the prostate and whether it will slow/stop spread of prostate cancer after treatment.
Detailed description
Men with high-risk prostate cancer are at the greatest risk for clinical progression, with 22 to 40% developing metastatic disease within 10 years of initial treatment. Furthermore, the finding of perineural invasion (PNI) on pathology (when prostate cancer cells invade the nerves that innervate the prostate), is associated with higher Gleason grades and an approximate doubling in risk of lethal prostate cancer. As 90% of prostate cancer metastasis involve the bone marrow, and 97% of bone marrow metastasis involve the lumbar vertebrate from which the pre-ganglionic sympathetic nerves that innervate the prostate derive, targeting this neuro-anatomic connection between the prostate and its primary site of metastasis is an active area of investigation. Therefore, development of therapeutic strategies targeting nerves to prevent clinical progression after definitive therapy for prostate cancer are urgently needed. In a Phase 1a dose escalation study (NCT06703437) we recently demonstrated that periprostatic neurolysis with 5mL pure ethanol was well tolerated with no AEs. This resulted in an approximate 30% reduction in prostatic adrenergic nerve density. The goal of this study is to optimize prostatic denervation by comparing the denervation efficiency of 1 vs 2 periprostatic ethanol injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single injection neurolysis | Experimental | Procedure: Periprostatic neurolysis with dehydrated alcohol (ethanol)Single injection of ethanol for periprostatic neurolysis |
| Two injection neurolysis | Experimental | Procedure: Periprostatic neurolysis with dehydrated alcohol (ethanol)Two temporally separated periprostatic ethanol injections |
| No injection control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- High risk prostate cancer as defined by NCCN criteria Desires surgical disease treatment (radical prostatectomy) Surgical candidate (for radical prostatectomy)
- ≤cT3a on MRI No seminal vesicle, lymph node, or metastatic disease on PSMA PET No prior prostate cancer treatment (including androgen deprivation therapy, radiation therapy, focal therapy, cryo therapy)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Periprostatic neurolysis with dehydrated alcohol (ethanol)Pre-operative ultrasound guided periprostatic neurolysis by injection of dehydrated alcohol | Procedure or surgery | Single injection neurolysis, Two injection neurolysis |
Primary outcome
Peritumoral adrenergic nerve density on final histology
Time frame: 4 to 6 weeks after treatment initiation
Will quantify degree of neurolysis by measuring decrease in adrenergic nerve density on radical prostatectomy specimen histology
3 secondary outcomes
Change in sexual health inventory for men (SHIM) score
Time frame: 4 to 6 weeks after intervention
Change in International Prostate Symptom Score (IPSS)
Time frame: 4 to 6 weeks after intervention
Change in post prostatectomy penile length
Time frame: 6months after surgery
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 29 Sep 2026.
- Background: PubMed 29051371Zahalka AH, Arnal-Estape A, Maryanovich M, Nakahara F, Cruz CD, Finley LWS, Frenette PS. Adrenergic nerves activate an angio-metabolic switch in prostate cancer. Science. 2017 Oct 20;358(6361):321-326. doi: 10.1126/science.aah5072.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Periprostatic neurolysis with dehydrated alcohol (ethanol) in people with PROSTATE CANCER and NERVES, run by University of Texas Southwestern Medical Center 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 2 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 29 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. 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?
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.
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?
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?
Peritumoral adrenergic nerve density on final histology (time frame: 4 to 6 weeks after treatment initiation). 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 NCT07100847, which also lists 1 linked publication.
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 29 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.