We perform a multicenter randomized controlled prospective study with superiority trial design, in which the polysaccharide ARISTA™ AH hemostat agent is applied to the neurovascular bundle areas after prostate removal, during Robot-assisted radical prostatectomy.
We examine if such agent leads to a relevant clinical improvement indicated by higher postoperative hemoglobin levels compared to the control group. As an exploratory co-primary endpoint of interest, we examine erectile function after Robot-assisted radical prostatectomy based on IIEF-5 score between groups 3, 6 and 12 months after Robot-assisted radical prostatectomy
Age range ≥ 45 to ≥68 yrs
Biopsy proven prostate cancer treated with robotic-assisted radical prostatectomy
Intrafascial nerve sparing surgery (unilaterally or bilaterally)
Preoperative urinary continence
Severe intellectual limitations preventing to fully understand the study concept and its content
High risk prostate cancer (PSA ≥ 20 ng/ml or biopsy Gleason-Score ≥ 8 or suspected T4)
Suspected bone or visceral metastases at preoperative imaging Neoadjuvant androgen deprivation therapy
Any prior local therapy of the prostate (including subvesical deobstruction or radiation therapy)
Parallel
Arm A - Application of 5g of ARISTA™ AH
Procedure/SurgeryPerioperative application of 5g of ARISTA™ AH to the prostate bed and neurovascular bundles during and at the end of the surgery to control bleeding and oozing in accordance with labelled directions; no other hemostyptic agent in aforementioned area
postoperative blood loss
In theory, the experimental treatment should not have any improvement in ΔHgB between day 5-6 day and preoperative hemoglobin levels
comparison between groups A and B concerning the unassisted IIEF-5 score between groups
A difference of the median IIEF-5 score of minimally four points between groups is considered as clinically relevant. Based on these considerations, 84 patients per treatment arm are required (including an assumed dropout rate of 33% or less). As it is possible that the effect of nerve stabilization of ARISTA™ AH may differ according to the preoperative potency status, two groups of patients will be analyzed:
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St. Antonius Hospital Gronau
Lead sponsor
Becton, Dickinson and Company
Collaborator
University of Leipzig
Collaborator
Universitätsklinikum Hamburg-Eppendorf
Collaborator
