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A Study of Changes to Prostate Procedures
Trial Status: active
This phase III trial studies whether changing care during prostate procedures improves the outcomes of patients following the procedure (post-procedure) compared to standard care. Prostate procedures can include transperineal prostate needle biopsies and prostate gland ablation. A transperineal prostate needle biopsy uses a needle to take tissue samples from the prostate gland through the perineum, which is the area between the scrotum and the anus. While transperineal prostate needle biopsies have fewer complications, patients often experience high rates of post-procedure pain despite being put to sleep with medication (sedation). The change in care for transperineal prostate needle biopsy in this trial includes giving a medication, bupivacaine hydrochloride, to areas near the prostate (locally) to cause a temporary loss of feeling, which may improve post-procedure pain. Prostate gland ablation uses energy to destroy prostate tissue. For this procedure, a flexible plastic tube (foley catheter) is inserted into the bladder to provide continuous urinary drainage, which can lead to the inability to completely empty the bladder with urination (urinary retention). The change in care for prostate gland ablation in this trial includes giving medications such as tamsulosin, oxybutynin, celecoxib, phenazopyridine, ketorolac, and dexamethasone or methylprednisolone before and after the procedure to lower prostate swelling and inflammation as well as burning with urination. This may lower urinary retention post-procedure. Making changes during prostate procedures may improve post-procedure patient outcomes.
Inclusion Criteria
LOCAL ANESTHESIA VERSUS NO LOCAL ANESTHESIA DURING TRANSPERINEAL BIOPSY, WHILE THE PATIENT IS UNDER IV SEDATION: Patients scheduled for transperineal prostate biopsy at the Josie Robertson Surgery Center (JRSC) or Monmouth
STANDARDIZATION OF A PERIPROCEDURAL PATHWAY VERSUS USUAL CARE FOR FOCAL GLAND ABLATION: Patients scheduled for a partial prostate gland ablation procedure at the JRSC
Additional locations may be listed on ClinicalTrials.gov for NCT06986083.
I. Determine whether modifications to prostate needle-based procedures are associated with better patient outcomes.
II. Evaluate whether the use of local anesthesia at the time of transperineal prostate biopsy, while the patient is under intravenous (IV) sedation reduces the proportion of patients experiencing significant pain in post-anesthesia care unit (PACU), defined as at least one pain score ≥ 5 on a 0 – 10 scale. (Transperineal biopsy study)
III. Evaluate whether the use of a standardized perioperative pathway reduces the rate of urinary retention. (Focal therapy study)
SECONDARY OBJECTIVES:
I. Evaluate the effects of local anesthesia on narcotic dose, time to discharge and post-discharge patient-reported outcomes. (Transperineal biopsy study)
II. Evaluate the effects of the standardized perioperative pathway on readmission rates for complications and post-discharge patient-reported outcomes. (Focal therapy study)
OUTLINE: Patients are assigned to 1 of 2 studies.
TRANSPERINEAL BIOPSY STUDY: Surgeons are randomized for periods of 3 months to 1 of 2 arms and patients are assigned to the arm to which their surgeon was randomized.
ARM I: Patients undergo prostate block using local anesthesia with bupivacaine hydrochloride over 30-90 seconds prior to the start of transperineal prostate biopsy.
ARM II: Patients receive standard of care (SOC) treatment during transperineal prostate biopsy.
FOCAL THERAPY STUDY: Surgeons are randomized for periods of 3 months to 1 of 2 arms and patients are assigned to the arm to which their surgeon was randomized.
ARM III: Patients receive SOC trimethoprim-sulfamethoxazole twice daily (BID) for 3 doses, oxybutynin three times daily (TID) for 3 days, celecoxib BID for 7 days, and phenazopyridine as needed starting at the time of foley catheter removal, around day 5 or 6 post-focal gland ablation, in the absence of unacceptable toxicity. Patients also receive tamsulosin for 14 days starting 3 days before focal gland ablation procedure, ketorolac around the time of the focal gland ablation procedure, and dexamethasone or methylprednisolone taper starting on day 1 post-focal gland ablation in the absence of unacceptable toxicity.
ARM IV: Patients receive SOC trimethoprim-sulfamethoxazole BID for 3 doses at the time of foley catheter removal, around day 5 or 6 post-focal gland ablation, in the absence of unacceptable toxicity.
After completion of study intervention, patients are followed up as per routine clinical care.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
