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NCT06703437 · ClinicalTrials.gov registry record · Phase 1
Long Acting Neuraxial Peri-prostatic Block in Cancer
A Phase 1 study of Prostate Cancer, sponsored by Icahn School of Medicine at Mount Sinai.
- Active
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT06703437: Active Phase 1 study of Prostate Cancer, sponsored by Icahn School of Medicine at Mount Sinai.
NCT06703437 is a Phase 1 study of Prostate Cancer that is active but no longer recruiting, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 12 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06703437, a Phase 1 study of Prostate Cancer, is active but no longer recruiting, sponsored by Icahn School of Medicine at Mount Sinai.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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. 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Lidocaine IV
- DRUG Dehydrated alcohol
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-12-13 |
| Est. Completion | 2026-06-01 |
| Phase | Phase 1 |
What the registry record for NCT06703437 still lists
NCT06703437 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Lidocaine IV is the first listed.
NCT06703437 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06703437 about?
NCT06703437 is a clinical study titled "Long Acting Neuraxial Peri-prostatic Block in 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...
What is the current status of trial NCT06703437?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2022-12-13. Estimated completion is 2026-06-01.
What conditions does trial NCT06703437 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT06703437?
The interventions under investigation include: Lidocaine IV (DRUG), Dehydrated alcohol (DRUG).
Who is sponsoring clinical trial NCT06703437?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06703437 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06703437's enrollment target sits among peer trials
12 703rd of 735 higher than 23 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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