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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long-acting neuraxial blockade | Experimental | Long-acting neuraxial blockade at the time of prostate biopsy by periprostatic injection of Dehydrated alcohol + lidocaine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dehydrated alcohol | Drug | Long-acting neuraxial blockade at the time of prostate biopsy by periprostatic injection of Dehydrated alcohol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | At week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to biochemical recurrence | Absence or presence of any evidence of biochemical recurrence at two years after definitive treatment for prostate cancer. | at month 6 and at year 2 |
| Response Rate |
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Inclusion Criteria:
Exclusion Criteria:
Limited to Male with high risk prostate cancer clinical features
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| Name | Affiliation | Role |
|---|---|---|
| Ali Zahalka, MD, PhD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Ash Tewari | Icahn School of Medicine at Mount Sinai | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication.
Researchers who provide a methodologically sound proposal.
To achieve aims in the approved proposal.
Proposals should be directed to ali.zahalka@mountsinai.org. To gain access, data requestors need to sign a data access agreement. Proposals may be submitted up to 36 months following article publication. Data will be shared by email.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Lidocaine IV | Drug | By periprostatic injection, 2mL |
|
Evidence of response supported by either histologic markers of treatment response, evidence based on difference in molecular proliferation markers between PBx and prostatectomy specimen.
| at week 8 |
| Tumor immunogenicity | Evidence based on tumor immunogenicity as measured by PD1/PDL-1 expression by immunohistochemistry on final pathology. | at week 8 |
| Degree of neural inhibition | Histological quantification of adrenergic nerve density by tyrosine hydroxylase positive nerve staining | at week 8 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |