Status:

RECRUITING

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

Lead Sponsor:

St. Antonius Hospital Gronau

Collaborating Sponsors:

Becton, Dickinson and Company

University of Leipzig

Conditions:

Prostate Cancer (Adenocarcinoma)

Blood Loss, Postoperative

Eligibility:

MALE

45-68 years

Phase:

NA

Brief Summary

Background and aim of the study: Radical prostatectomy (RP) is one of the most commonly used treatment options for localized prostate cancer (PCa). Blood loss and deterioration of erectile function is...

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)

Key Trial Info

Start Date :

January 16 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 30 2027

Estimated Enrollment :

362 Patients enrolled

Trial Details

Trial ID

NCT06822036

Start Date

January 16 2025

End Date

January 30 2027

Last Update

February 17 2025

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Martini Klinik am UKE GmbH

Hamburg, Free and Hanseatic City of Hamburg, Germany, 20246

2

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

Gronau, North Rhine-Westphalia, Germany, 48599

3

Klinik und Poliklinik für Urologie des Universitätsklinikums Leipzig

Leipzig, Saxony, Germany, 04103