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

Last updated: May 27, 2026
Sponsor: St. Antonius Hospital Gronau
Overall Status: Active - Recruiting

Phase

N/A

Condition

Adenocarcinoma

Prostate Cancer

Hemorrhage

Treatment

Arm A - Application of 5g of ARISTA™ AH

Clinical Study ID

NCT06822036
2023-601-f-S
  • Ages 45-68
  • Male

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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)-5score range 8-16 (i.e. moderate (8-11) and mild to moderate (12-16))

Exclusion

Exclusion Criteria:

  • Severe intellectual limitations preventing to fully understand the study concept andits content

  • High risk prostate cancer (PSA ≥ 20 ng/ml or biopsy Gleason-Score ≥ 8 or suspectedT4)

  • Suspected bone or visceral metastases at preoperative imaging Neoadjuvant androgendeprivation therapy

  • Any prior local therapy of the prostate (including subvesical deobstruction orradiation 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 formost 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

  • For a) nerve sparing and b) controlling bleeding in the area of the prostate bed andneurovascular bundles after prostate removal, no monopolar thermal application areallowed but suturing and clip application is allowed. For secondary resection of theneurovascular bundle and controlling bleeding, mono- or bipolar thermal application,clip application and suturing is allowed.

  • No surgical revision within 7d after RARP (Clavien Dindo classified complication ≥3b)

  • No definitive anastomotic partial or complete rupture (identified via cystogramwithin 30d after RARP)

Study Design

Total Participants: 362
Treatment Group(s): 1
Primary Treatment: Arm A - Application of 5g of ARISTA™ AH
Phase:
Study Start date:
January 16, 2025
Estimated Completion Date:
January 30, 2027

Connect with a study center

  • Martini Klinik am UKE GmbH

    Hamburg, Free and Hanseatic City of Hamburg 20246
    Germany

    Active - Recruiting

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

    Gronau, North Rhine-Westphalia 48599
    Germany

    Active - Recruiting

  • Klinik und Poliklinik für Urologie des Universitätsklinikums Leipzig

    Leipzig, Saxony 04103
    Germany

    Active - Recruiting

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