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Tests treatment safety and results for Prostate Cancer (Adenocarcinoma)
Official title EFFICACY OF INTRAOPERATIVE ARISTA POLYSACCHARIDE APPLICATION ON THE POSTOPERATIVE BLOOD LOSS IN PATIENTS UNDERGOING RARP FOR THE TREATMENT OF PROSTATE CANCER
ClinicalTrials.gov ID: NCT06822036
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 68, men only
You may be able to join if
- 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))
You likely can't join if
- 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
See the full eligibility 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))
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Hamburg, Free and Hanseatic City of Hamburg, Germany
- Gronau, North Rhine-Westphalia, Germany
- Leipzig, Saxony, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 45 years to 68 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamburg, Free and Hanseatic City of Hamburg, Germany; Gronau, North Rhine-Westphalia, Germany; Leipzig, Saxony, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.