Prostate Cancer (Adenocarcinoma)ARISTANCT06822036
EFFICACY OF INTRAOPERATIVE ARISTA POLYSACCHARIDE APPLICATION ON THE POSTOPERATIVE BLOOD LOSS IN PATIENTS UNDERGOING RARP FOR THE TREATMENT OF PROSTATE CANCER
A study testing Arm A - Application of 5g of ARISTA™ AH in people with Prostate Cancer (Adenocarcinoma) and Blood Loss, Postoperative, run by St. Antonius Hospital Gronau at 3 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 68 years, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma), Blood Loss, Postoperative, Erectile Function
- What is being tested?
- Arm A - Application of 5g of ARISTA™ AH
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 3 sitesGermany
- Study dates
- 16 Jan 2025to 30 Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 68 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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))
Who cannot join
- 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
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- 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)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Recruiting
St. Antonius-Hospital Gronau GmbH, Klinik für Urologie, Urologische Onkologie und Roboter-assistierte Chirurgie
Gronau, North Rhine-Westphalia, 48599
Katarina Urbanova, Dr. rer. nat, +4925629157154, katarina.urbanova@st-antonius-gronau.de
Sami-Ramzi Leyh-Bannurah, PD
- Recruiting
Martini Klinik am UKE GmbH
Hamburg, Free and Hanseatic City of Hamburg, 20246
Sami-Ramzi Leyh-Bannurah, PD., +49741051305, sami-ramzi.leyh-bannurah@uke.de
- Recruiting
Klinik und Poliklinik für Urologie des Universitätsklinikums Leipzig
Leipzig, Saxony, 04103
Sigrun Holze, Dr., +49 341 97 17629, Sigrun.Holze@medizin.uni-leipzig.de
About this study
Official 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
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
- Being tested
- Arm A - Application of 5g of ARISTA™ AH
- Keywords
- prostate cancer, blood loss, potency rates, ARISTA™ AH
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma, Postoperative Hemorrhage, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm A - Application of 5g of ARISTA™ AHProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Arm B - no periooperative application of 5g of ARISTA™ AH | No intervention | No perioperative application of ARISTA™ AH to the prostate bed and neurovascular bundles at the end of the surgery; no other hemostyptic agent in aforementioned area; (ARISTA™ AH application outside of aforementioned areas are allowed; e.g. to the fossa obturatoria) |
| Arm A - periooperative application of 5g of ARISTA™ AH | Active comparator | 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 Receives: Procedure: Arm A - Application of 5g of ARISTA™ AH |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative blood loss
In theory, the experimental treatment should not have any improvement in ΔHgB between day 5-6 day and preoperative hemoglobin levels
Measured: improvement in ΔHgB between day 5-6 day and preoperative hemoglobin levels
comparison between groups A and B concerning the unassisted IIEF-5 score between groups
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:
Measured: 3, 6 and 12 months after RARP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start16 Jan 2025
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 362 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital Gronau
- Sponsor type
- University, hospital or other
- Collaborators
- Becton, Dickinson and Company, University of Leipzig, Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Sponsor
- Investigators
- Sami-Ramzi Leyh-Bannurah, PD, Principal investigator, Klinik für Urologie, Urologische Onkologie und Roboter-assistierte Chirurgie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822036
- Sponsor's protocol ID
- 2023-601-f-S
- Acronym
- ARISTA
- Status last verified
- May 2026
- First submitted
- 6 Feb 2025
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No