Three-dimensional augmented reality-assisted surgery versus two-dimensional conventional robot-assisted surgery for prostate cancer

Not Applicable

• Conditions: Prostate cancer; Cancer

• Registration Number: ISRCTN15750887
• Lead Sponsor: Istituti di Ricovero e Cura a Carattere Scientifico

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-30
• Last Update Posted: 13 February 2023
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 132

Inclusion Criteria

1. Signature of written informed consent and consent to use of personal data
2. Aged 40 years old and over and male
3. Preoperative MRI performed according to ESUR recommendations and reported in accordance with PiRads V.2
4. Disease with pre-operative MRI finding of bulging or radiological T3
5. Histological diagnosis of acinar prostate carcinoma at the level of the area shown on MRI
6. Absence of retroperitoneal or pelvic bulky (>3 cm) lymph node, bone or visceral metastatic lesions
7. Patients eligible for radical prostatectomy + pelvic lymphadenectomy
8. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
9. Life expectancy =5 years
10. Patients motivated to preserve an erection and with pre-operative sexual activity with IIEF >17
11. Availability of patient's pre-operative clinical data
12. Patients must be available for protocol follow-up visits and consent to data collection

Exclusion Criteria

1. Special histotypes of prostate cancer
2. Patients with PSA >100 ng/ml at diagnosis
3. Unable to perform MRI (pacemaker wearers, claustrophobia) or MRI of inadequate quality to obtain 3D reconstruction
4. Concomitant treatment with other antineoplastic drugs including experimental endocrine therapies
5. Severe disease or concomitant uncontrolled medical condition including active and uncontrolled infections
6. Patients with dementia or psychiatric illness that would limit compliance with the requirements of the study or could prevent understanding and/or signing of informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified