Clinical trial · Interventional
Periprostatic Neurolysis in Prostate Cancer
Phase 1b Window of Opportunity Study of Peri-prostatic Neurolysis in High-risk Localized Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NERVES | — | UNRESOLVED | — |
| NEUROBIOLOGY OF CANCER | Prostate Neoplasm | PROBABILISTIC | 0.70 |
| NEUROLYSIS | — | UNRESOLVED | — |
| PROSTATE CANCER | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Periprostatic neurolysis with dehydrated alcohol (ethanol) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Single injection neurolysis
- description
- Single injection of ethanol for periprostatic neurolysis
- interventionNames
- Procedure: Periprostatic neurolysis with dehydrated alcohol (ethanol)
- type
- EXPERIMENTAL
- label
- Two injection neurolysis
- description
- Two temporally separated periprostatic ethanol injections
- interventionNames
- Procedure: Periprostatic neurolysis with dehydrated alcohol (ethanol)
- type
- NO_INTERVENTION
- label
- No injection control
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: 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)
References
Publications (1)
- BACKGROUNDZahalka 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. PMID 29051371