Prostate Cancer
Conditions
Keywords
prostate cancer, radical prostatectomy, deep venous complex ligation
Brief summary
The aim of the study is to evaluate the impact of early deep venous complex ligation (eDVCL) in patients affected by clinically localized prostate cancer (PCa) undergoing robot-assisted radical prostatectomy with or without pelvic lymph node dissection. Overall, 312 patients will be randomized to the standard technique vs. eDVCL. The primary endpoint is represented by early urinary continence recovery. The secondary endpoints are perioperative outcomes, erectile function recovery and positive surgical margins.
Interventions
PROCEDUREEarly DVC ligation
After the posterior isolation of seminal vesicles, the Retzius space will be accessed and the endopelvic fascia will be incised. The DVC will be identified and incised. The DVC will be then selectively ligated using a V-lok 3/0 barbed suture. This approach would allow for the preservation of the external urethral sphincter and for the identification and preservation of the neurovascular bundles that are located in the anterolateral aspect of the prostate. After the early DVC isolation, incision and ligation, the bladder neck will be incised and preserved when possible. A posterior nerve sparing approach will be then performed. During apical dissection, the urethral sphincter will be identified and carefully preserved. Posterior reconstruction and anastomosis will be then performed.
Sponsors
IRCCS San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Male patients, aged between 18 and 80 years old 2. Planned to receive robot-assisted radical prostatectomy for prostate cancer 3. Able to understand and willing to sign a written informed consent document 4. On stable dose of current regular medication for at least 4 weeks prior to trial entry
Exclusion criteria
The participant may not enter the trial if ANY of the following apply: 1. Life expectancy of less than 12 months 2. Previous chemotherapy 3. Previous brachytherapy or external beam radiotherapy 4. Preexisting urinary incontinence defined as 1 or more pads per day 5. Unstable cardiovascular disease 6. Congestive Heart Failure (CHF) 7. Clinically significant hepatobiliary or renal disease 8. History of significant CNS injuries within 6 months 9. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early urinary continence recovery | 4 weeks | Continence recovery evaluated with the ICIQ-SF questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary continence recovery | 16 weeks | Continence recovery evaluated with Continence recovery evaluated with the ICIQ-SF questionnaire |
| Erectile function recovery | 16 weeks | Erectile function recovery evaluated with the IIEF questionnaire |
| Positive surgical margins | 4 weeks | Positive surgical margins |
| PSA persistence or biochemical recurrence | 4, 16 and 48 weeks | Serum PSA levels |
| Perioperative outcomes | 30 days | Postoperative complications according to the Clavien-Dindo classification |
Countries
Italy
Outcome results
None listed