Using ARISTA polysaccharide to reduce blood loss during prostate cancer surgery
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
This study is testing if using a special gel during prostate cancer surgery can help reduce blood loss and improve recovery for men having nerve-sparing surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 362 (estimated) |
| Ages | 45 Years to 68 Years |
| Sex | Male |
| Sponsor | St. Antonius Hospital Gronau Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Hamburg, Free and Hanseatic City of Hamburg and 2 other locations) |
| Trial ID | NCT06822036 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men aged 45 to 68 with localized prostate cancer undergoing robotic-assisted radical prostatectomy with nerve-sparing techniques.
Not a fit: Patients with high-risk prostate cancer, prior local therapy, or significant psychological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce blood loss during prostate cancer surgery and improve recovery outcomes for patients.
How similar studies have performed: Previous studies have shown promising results with similar interventions aimed at reducing blood loss in surgical procedures, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hamburg, Free and Hanseatic City of Hamburg and 2 other locations
- Martini Klinik am UKE GmbH — Hamburg, Free and Hanseatic City of Hamburg, Germany (Not_yet_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 (Not_yet_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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.