Powder during prostate surgery may cut bleeding and save sexual function
NCT ID NCT06822036
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether applying a powder called ARISTA AH during robotic prostate removal can reduce blood loss and help preserve erectile function. About 362 men with prostate cancer will be randomly assigned to receive the powder or standard care. The goal is to see if the powder leads to higher hemoglobin levels after surgery and better erectile function up to a year later.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 362 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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45 to 68 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Klinik und Poliklinik für Urologie des Universitätsklinikums Leipzig
RECRUITINGLeipzig, Saxony, 04103, Germany
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Martini Klinik am UKE GmbH
RECRUITINGHamburg, Free and Hanseatic City of Hamburg, 20246, Germany
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St. Antonius-Hospital Gronau GmbH, Klinik für Urologie, Urologische Onkologie und Roboter-assistierte Chirurgie
RECRUITINGGronau, North Rhine-Westphalia, 48599, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Radioactive missile aims at prostate cancer that spread
- New PET tracer targets ACP3 to spot prostate cancer
- Can a One-Week radiation course match four weeks for prostate cancer?
- Can a new PET tracer spot hidden prostate cancer spread?
- Can a gel cushion shield the rectum during prostate radiation?
- A scanner in the operating room could show surgeons exactly where prostate cancer remains