EFFICACY OF INTRAOPERATIVE ARISTA POLYSACCHARIDE APPLICATION ON THE POSTOPERATIVE BLOOD LOSS IN PATIENTS UNDERGOING RARP FOR THE TREATMENT OF PROSTATE CANCER

NCT06822036 | Recruiting

• 1 other identifier: 2023-601-f-S
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Prostate Cancer (Adenocarcinoma); Blood Loss, Postoperative; Erectile Function

Keywords

prostate cancer; blood loss; potency rates; ARISTA™ AH

Outcome Measures

Primary Outcomes (2)

• postoperative blood loss

  In theory, the experimental treatment should not have any improvement in ΔHgB between day 5-6 day and preoperative hemoglobin levels

  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:

  3, 6 and 12 months after RARP

Study Arms (2)

Arm B - no periooperative application of 5g of ARISTA™ AH

NO INTERVENTION

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)

Arm A - periooperative application of 5g of ARISTA™ AH

ACTIVE COMPARATOR

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

Interventions

Arm A - Application of 5g of ARISTA™ AH PROCEDURE

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

Arm A - periooperative application of 5g of ARISTA™ AH

Eligibility Criteria

• Age: 45 Years - 68 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Group A Preoperative unassisted International Index of Erectile function (IIEF)-5 score range 8-16 (i.e. moderate (8-11) and mild to moderate (12-16))

You may not qualify if:

• 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)
• Any prior chemotherapy or colon/rectal surgery
• Any prior pelvic trauma that required surgical intervention
• Depression or other psychological or neurological disease (dementia, schizophrenia, bipolar disorder etc.)
• Peyronie's disease
• Polyneuropathia
• IPSS Score \>19 and QoL \>3
• Bilateral secondary (complete or partial) resection of the neurovascular bundle
• No contraindications for phosphodiesterase type 5 inhibitor intake (i.e. suited for most penile rehabilitation regimes)
• Any endocrine function disorder (not including diabetes)
• SURGICAL AND PERIOPERATIVE EXLUSION CRITERIA:
• Accessory pudendal arteries (APA) preservation, if an APA is identified

Sponsors & Collaborators

• St. Antonius Hospital Gronau: lead
• Becton, Dickinson and Company: collaborator
• University of Leipzig: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator

Study Sites (3)

Martini Klinik am UKE GmbH

Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

RECRUITING

St. Antonius-Hospital Gronau GmbH, Klinik für Urologie, Urologische Onkologie und Roboter-assistierte Chirurgie

Gronau, North Rhine-Westphalia, 48599, Germany

RECRUITING

Klinik und Poliklinik für Urologie des Universitätsklinikums Leipzig

Leipzig, Saxony, 04103, Germany

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma; Postoperative Hemorrhage; Hemorrhage

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Study Officials

• Sami-Ramzi Leyh-Bannurah, PD

  Klinik für Urologie, Urologische Onkologie und Roboter-assistierte Chirurgie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sami-Ramzi Leyh-Bannurah, PD. Dr.

CONTACT

+49741051305; sami-ramzi.leyh-bannurah@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 12, 2025
• Study Start: January 16, 2025
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)