Table 1:
Randomized Controlled Trials on Robot-Assisted Versus Open or Laparoscopic Radical Prostatectomy
| Author, Year | Country | Patient Eligibility | Surgeon | Comparators | Main Outcomes | Follow-Up |
|---|---|---|---|---|---|---|
| Robot-assisted vs. open radical prostatectomy | ||||||
| Yaxley et al, 201626 | Australia | Inclusion: age 35–75 years, newly diagnosed clinically localized prostate cancer; no previous history of head injury, dementia, or psychiatric illness; no concurrent other cancer; estimated life expectancy ≥ 10 years Exclusion: evidence of nonlocalized prostate cancer, PSA > 20 ng/mL, previous laparoscopic hernia repair, previous pelvic radiotherapy or major pelvic surgery, another malignancy within past 5 years |
1 surgeon > 200 RARPs 1 surgeon > 1,500 ORPs |
RARP ORP | Primary: urinary continence, erectile function, oncological outcomes Secondary: pain, physical and mental functioning, fatigue, bowel function, prostate cancer distress, psychological distress, time to return to work |
24 months (results not yet reported) (3-month interim results reported so far) |
| Robot-assisted vs. laparoscopic radical prostatectomy | ||||||
| Asimakopoulos et al, 201130 | Italy | Inclusion: age ≤ 70 years, clinically organ-confined prostate cancer (clinical stage T1–T2), Gleason score ≤ 7, total serum PSA ≤ 10 ng/mL, normal preoperative continence, IIEF-6 ≥ 17, and normal IPSS Exclusion: preoperative incontinence or moderate to severe erectile dysfunction (IIEF-6 < 17); neoadjuvant therapy; any previous prostatic, urethral, or bladder neck surgery; positive MRI results for extracapsular extension; no bilateral nerve sparing |
1 surgeon (> 300 RARPs, > 900 LRPs) | RARP LRP |
Primary: erectile function, continence at 12 months Secondary: perioperative outcomes, complication rate, oncological outcomes |
12 months |
| Porpiglia et al, 201329 | Italy | Inclusion: age 40–75 years, T1-T2N0M0, any prostate size Exclusion: previous radiation therapy, hormonal therapy, transurethral resection of the prostate |
1 surgeon (> 100 RARPs, > 600 LRPs) | RARP LRP |
Primary: continence at 3 months Secondary: continence at different times, perioperative results, rate of PSM, recovery of erectile function |
12 months |
Abbreviations: IIEF, International Index of Erectile Function Questionnaire; IPSS, International Prostate Symptom Score; LRP, laparoscopic radical prostatectomy; MRI, magnetic resonance imaging; PSA, prostate-specific antigen; ORP, open radical prostatectomy; PSM, positive surgical margin; RARP, robot-assisted radical prostatectomy; TNM, tumour staging (tumour, lymph node, metastasis).