An interventional study of Arm A - Application of 5g of ARISTA™ AH in Prostate Cancer (Adenocarcinoma), Blood Loss, Postoperative and Erectile Function, sponsored by St. Antonius Hospital Gronau. Recruiting at 3 sites in Germany. Open to male participants aged 45 Years to 68 Years. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by St. Antonius Hospital Gronau · Not applicable, Interventional, and Prevention
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
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 362 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →St. Antonius Hospital Gronau is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
SURGICAL AND PERIOPERATIVE EXLUSION CRITERIA:
No perioperative application of ARISTA™ AH to the prostate bed and neurovascular bundles at the end of the surgery; no other hemostyptic agent in aforementioned area; (ARISTA™ AH application outside of aforementioned areas are allowed; e.g. to the fossa obturatoria)
Perioperative 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
Procedure: Arm A - Application of 5g of ARISTA™ AH
Perioperative 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
Time frame: 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:
Time frame: 3, 6 and 12 months after RARP
Plan to share: No
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St. Antonius Hospital Gronau