Using ARISTA polysaccharide to reduce blood loss during prostate cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy of applying ARISTA™ AH, a polysaccharide, during robotic-assisted radical prostatectomy (RARP) for patients with prostate cancer. The study aims to determine if this intervention can reduce postoperative blood loss and improve functional outcomes, such as erectile function and urinary continence. Eligible participants include men aged 45 to 68 with biopsy-proven prostate cancer who are undergoing nerve-sparing surgery. The trial will assess the impact of ARISTA™ AH application on surgical outcomes compared to standard procedures.

Why it matters

Who can join: the full rules

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)

Where it's running

• Martini Klinik am UKE GmbH
  Hamburg, Free and Hanseatic City of Hamburg, Germany Recruiting
• St. Antonius-Hospital Gronau GmbH, Klinik für Urologie, Urologische Onkologie und Roboter-assistierte Chirurgie
  Gronau, North Rhine-Westphalia, Germany Recruiting
• Klinik und Poliklinik für Urologie des Universitätsklinikums Leipzig
  Leipzig, Saxony, Germany Recruiting

Study contacts

• Principal investigator: Sami-Ramzi Leyh-Bannurah, PD — Klinik für Urologie, Urologische Onkologie und Roboter-assistierte Chirurgie
• Study coordinator: Sami-Ramzi Leyh-Bannurah, PD. Dr.
• Email: sami-ramzi.leyh-bannurah@uke.de
• Phone: +49741051305

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.