Prostate Cancer
Conditions
Brief 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.
Interventions
Long-acting neuraxial blockade at the time of prostate biopsy by periprostatic injection of Dehydrated alcohol.
DRUGLidocaine IV
By periprostatic injection, 2mL
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-Limiting Toxicity (DLT) | 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) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to biochemical recurrence | at month 6 and at year 2 | Absence or presence of any evidence of biochemical recurrence at two years after definitive treatment for prostate cancer. |
| Response Rate | at week 8 | Evidence of response supported by either histologic markers of treatment response, evidence based on difference in molecular proliferation markers between PBx and prostatectomy specimen. |
| Tumor immunogenicity | at week 8 | Evidence based on tumor immunogenicity as measured by PD1/PDL-1 expression by immunohistochemistry on final pathology. |
| Degree of neural inhibition | at week 8 | Histological quantification of adrenergic nerve density by tyrosine hydroxylase positive nerve staining |
Countries
United States
Outcome results
None listed