Prostate CancerPhase 1NCT06703437
Long Acting Neuraxial Peri-prostatic Block in Cancer
A Phase 1 study testing Dehydrated alcohol and Lidocaine IV in people with Prostate Cancer, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Disease progression after definitive therapy for prostate cancer is a major source of morbidity and mortality. Adrenergic/sympathetic innervation of the prostate is essential for prostate cancer progression, and abrogation of these signals by blocking adrenergic innervation halts disease progression. Read more about this study
- Who is it for?
- Ages 45 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Dehydrated alcohol and Lidocaine IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2022to 1 Jun 2026
- 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 45 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PSA >10
- PSAD >0.15
- PI-RADS 5 lesion on MRI
- Karnofsky performance status >80
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Prior or concomitant treatment for prostate cancer, including radiation therapy, focal therapy, cryo therapy, androgen deprivation therapy.
- Imaging or clinical evidence of metastatic disease.
- PSA > 100ng/mL
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: A Phase I Open Label Peri-prostatic Neuraxial Block With Lidocaine and Ethanol in High-risk Localized Prostate Cancer
Disease progression after definitive therapy for prostate cancer is a major source of morbidity and mortality. Adrenergic/sympathetic innervation of the prostate is essential for prostate cancer progression, and abrogation of these signals by blocking adrenergic innervation halts disease progression. Long-acting neuraxial block of the sympathetic nerves that innervate the pelvis with dehydrated alcohol (>98% Ethanol) is a safe and effective tool in the treatment of chronic pelvic pain and cancer- induced pelvic pain. Furthermore, ultrasound guided periprostatic neuraxial block at the time of prostate biopsy with short-acting lidocaine is standard of care. Herein the research team proposes to administer a long-acting periprostatic neuraxial block with dehydrated alcohol and lidocaine under trans rectal ultrasound guidance in patients with high-risk clinical features for prostate cancer at the time of prostate biopsy.
- Conditions
- Prostate Cancer
- Being tested
- Dehydrated alcohol, Lidocaine IV
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dehydrated alcoholDrug
Long-acting neuraxial blockade at the time of prostate biopsy by periprostatic injection of Dehydrated alcohol.
Lidocaine IVDrug
By periprostatic injection, 2mL
| Study group | Role | What they receive |
|---|---|---|
| Long-acting neuraxial blockade | Experimental | Long-acting neuraxial blockade at the time of prostate biopsy by periprostatic injection of Dehydrated alcohol + lidocaine. Receives: Drug: Dehydrated alcohol; Drug: Lidocaine IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity (DLT)
The DLT will be measured in the two week post administration period. The target toxicity rate is assumed as 25% considering immediate post-administration toxicity. This rate will not account for the delayed onset toxicities.
Measured: At week 2
Maximally Tolerated Dose (MTD)
The MTD will be defined as the dose at which the isotonic estimate of the toxicity rate is closest to the target toxicity rate of 25%. The MTD will be used as a recommended dose for prospective Phase II study in future
Measured: At week 2
Secondary outcomes (4)
Time to biochemical recurrence
Absence or presence of any evidence of biochemical recurrence at two years after definitive treatment for prostate cancer.
Measured: at month 6 and at year 2
Response Rate
Evidence of response supported by either histologic markers of treatment response, evidence based on difference in molecular proliferation markers between PBx and prostatectomy specimen.
Measured: at week 8
Tumor immunogenicity
Evidence based on tumor immunogenicity as measured by PD1/PDL-1 expression by immunohistochemistry on final pathology.
Measured: at week 8
Degree of neural inhibition
Histological quantification of adrenergic nerve density by tyrosine hydroxylase positive nerve staining
Measured: at week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start13 Dec 2022
- Primary completion23 Feb 2023
- Study completion1 Jun 2026 (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 Icahn School of Medicine at Mount SinaiThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Zahalka, Icahn School of Medicine at Mount Sinai
- Investigators
- Ali Zahalka, MD, PhD, Principal investigator, Icahn School of Medicine at Mount SinaiAsh Tewari, Study director, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703437
- Sponsor's protocol ID
- STUDY-22-00221
- Status last verified
- Jun 2025
- First submitted
- 21 Nov 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open Label Peri-prostatic Neuraxial Block With Lidocaine and Ethanol in High-risk Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT06703437
- Acronym / sponsor ID
- STUDY-22-00221
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 25 Nov 2024 (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.
Disease progression after definitive therapy for prostate cancer is a major source of morbidity and mortality. Adrenergic/sympathetic innervation of the prostate is essential for prostate cancer progression, and abrogation of these signals by blocking adrenergic innervation halts disease progression. Long-acting neuraxial block of the sympathetic nerves that innervate the pelvis with dehydrated alcohol (>98% Ethanol) is a safe and effective tool in the treatment of chronic pelvic pain and cancer- induced pelvic pain. Furthermore, ultrasound guided periprostatic neuraxial block at the time of prostate biopsy with short-acting lidocaine is standard of care. Herein the research team proposes to administer a long-acting periprostatic neuraxial block with dehydrated alcohol and lidocaine under trans rectal ultrasound guidance in patients with high-risk clinical features for prostate cancer at the time of prostate biopsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long-acting neuraxial blockade | Experimental | Drug: Dehydrated alcohol, Drug: Lidocaine IVLong-acting neuraxial blockade at the time of prostate biopsy by periprostatic injection of Dehydrated alcohol + lidocaine. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- PSA >10
- PSAD >0.15
- PI-RADS 5 lesion on MRI
- Karnofsky performance status >80
- Ability to understand and the willingness to sign a written informed consent.
Key exclusion criteria (3 listed)
- Prior or concomitant treatment for prostate cancer, including radiation therapy, focal therapy, cryo therapy, androgen deprivation therapy.
- Imaging or clinical evidence of metastatic disease.
- PSA > 100ng/mL
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 |
|---|---|---|
| Dehydrated alcoholLong-acting neuraxial blockade at the time of prostate biopsy by periprostatic injection of Dehydrated alcohol. | Drug | Long-acting neuraxial blockade |
| Lidocaine IVBy periprostatic injection, 2mL | Drug | Long-acting neuraxial blockade |
Primary outcome
Dose-Limiting Toxicity (DLT)
Time frame: At week 2
The DLT will be measured in the two week post administration period. The target toxicity rate is assumed as 25% considering immediate post-administration toxicity. This rate will not account for the delayed onset toxicities.
Maximally Tolerated Dose (MTD)
Time frame: At week 2
The MTD will be defined as the dose at which the isotonic estimate of the toxicity rate is closest to the target toxicity rate of 25%. The MTD will be used as a recommended dose for prospective Phase II study in future
4 secondary outcomes
Time to biochemical recurrence
Time frame: at month 6 and at year 2
Response Rate
Time frame: at week 8
Tumor immunogenicity
Time frame: at week 8
Degree of neural inhibition
Time frame: at week 8
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 3 Sep 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Ali Zahalka, MD, PhD principal investigator
Icahn School of Medicine at Mount Sinai
Ash Tewari study director
Icahn School of Medicine at Mount Sinai
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 Dehydrated alcohol and Lidocaine IV in people with Prostate Cancer, run by Icahn School of Medicine at Mount Sinai 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 5 inclusion and 3 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 3 Sep 2025. 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?
Dose-Limiting Toxicity (DLT) (time frame: At week 2). The study lists 2 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 3 Sep 2025.