EFFICACY of INTRAOPERATIVE ARISTA POLYSACCHARIDE APPLICATION on the POSTOPERATIVE BLOOD LOSS in PATIENTS UNDERGOING RARP for the TREATMENT of PROSTATE CANCER

Launched by ST. ANTONIUS HOSPITAL GRONAU · Feb 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a special substance called ARISTA™ AH, which is applied during robotic-assisted surgery for prostate cancer, to see if it can help reduce blood loss and improve erectile function after the operation. The trial aims to find out if using this substance can lead to higher levels of hemoglobin, which is an important measure of blood health, and if it can help men maintain their erectile function after surgery.

Men aged 45 to 68 who have been diagnosed with prostate cancer and are planning to undergo this type of surgery may be eligible to participate. To join the study, participants should have a certain level of urinary control and erectile function before the surgery. During the trial, participants will be randomly assigned to receive either the ARISTA™ AH application or standard care, and they will be monitored for their recovery, including blood loss and changes in erectile function. This trial is important because it could lead to better surgical outcomes and improved quality of life for men undergoing treatment for prostate cancer.

Gender

MALE

Eligibility 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)