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Powder during prostate surgery may cut bleeding and save sexual function

NCT ID NCT06822036

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 362 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

45 to 68 years

Sex

Male participants only

Healthy volunteers

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

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.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Klinik und Poliklinik für Urologie des Universitätsklinikums Leipzig

    RECRUITING

    Leipzig, Saxony, 04103, Germany

  • Martini Klinik am UKE GmbH

    RECRUITING

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

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

    RECRUITING

    Gronau, North Rhine-Westphalia, 48599, Germany

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