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NCT Number: NCT06822036

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

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

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Key information

Conditions

Prostate Cancer (Adenocarcinoma) Adenocarcinoma Blood Loss, Postoperative Carcinoma Erectile Function Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Hemorrhage Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

45 year–68 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Martini Klinik am UKE GmbH, Hamburg, Free and Hanseatic City of Hamburg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • 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
  • For a) nerve sparing and b) controlling bleeding in the area of the prostate bed and neurovascular bundles after prostate removal, no monopolar thermal application are allowed but suturing and clip application is allowed. For secondary resection of the neurovascular 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 cystogram within 30d after RARP)

Treatment and study plan

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

Primary outcomes

  1. postoperative blood loss

    Time frame: improvement in ΔHgB between day 5-6 day and preoperative hemoglobin levels

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

  2. comparison between groups A and B concerning the unassisted IIEF-5 score between groups

    Time frame: 3, 6 and 12 months after RARP

    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:

Study contacts

Contact information is provided by the study sponsor or research team.

Sami-Ramzi Leyh-Bannurah, PD. Dr.

CONTACT

[email protected]

+49741051305

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital Gronau

Other

Collaborators

  • Becton, Dickinson and Company
  • University of Leipzig
  • Universitätsklinikum Hamburg-Eppendorf

Registry information

Official study title

PROSPECTIVE RANDOMIZED CONTROLLED TRIAL EVALUATING THE EFFICACY OF INTRAOPERATIVE ARISTA™ AH POLYSACCHARIDE APPLICATION ON THE POSTOPERATIVE BLOOD LOSS IN PATIENTS UNDERGOING ROBOTIC ASSISTED RADICAL PROSTATECTOMY FOR THE TREATMENT OF PROSTATE CANCER

Acronym: ARISTA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 12, 2025
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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