An interventional study of Robot-Assisted Telesurgery in Prostate Cancer and Colorectal Cancer, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 3 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Other
Among 337 studies in Prostatic Neoplasms with a site in Italy — 93 open to participants now, 140 under way, 35 of them phase 3. Prostatic Neoplasms · Italy.
Among the 337 studies in Prostatic Neoplasms with a site in Italy, this one is the 230th largest by planned enrollment of the 242 interventional ones that give a count, is one of 19 that started in 2026, is one of 56 with no phase, reaches primary completion later than 54 of the 139 other live ones, and was the 331st registered.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
Browse Prostatic Neoplasms studies →93 of the 337 studies in Prostatic Neoplasms with a site in Italy are open now. Recruiting first, the newest first:
Niguarda Hospital · Sites in Italy
Ages 18–85 · Men only
AstraZeneca · Sites in Italy, United States, Austria and 18 more countries
Ages 18+ · Men only
Istituto Clinico Humanitas · Sites in Italy
Ages 18+ · Men only
Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD · Sites in Italy, France, Germany and 2 more countries
Ages 18+ · Men only
AstraZeneca · Sites in Italy, United States, Australia and 4 more countries
Ages 18–99 · Men only
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 1,228 Prostatic Neoplasms studies recruiting now, 928 (76%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
337 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 22 · Phase 2 70 · Phase 3 104 · Phase 4 8
First in 1992; this study’s year is marked. 19 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 25 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Median enrollment 220 across the 242 interventional studies, 280 across the 93 observational. Of the 166 that completed or were terminated, 68 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
154 of 337 have an industry lead sponsor. The 10 most frequent:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS has 6 studies filed under Prostatic Neoplasms — fewer than ten, so there is no comparison to draw.
35 of the studies in Prostatic Neoplasms with a site in Italy that are under way reach primary completion within a year, 8 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03767244Phase 3Janssen Research & Development, LLCA Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy | 2026-12-01 |
| NCT06551324Phase 3PfizerA Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1). | 2027-02-28 |
| NCT06717711Phase 3Regina Elena Cancer InstituteLow-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers | 2027-02-28 |
| NCT06122584Phase 3ABX advanced biochemical compounds GmbHDiagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients With Newly-Diagnosed Prostate Cancer | 2027-03 |
| NCT05794906Phase 3BayerA Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) and Placebo Given With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies | 2027-07-30 |
Among the 337 studies in Prostatic Neoplasms with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This prospective, single-center pilot cohort study aims to evaluate the feasibility and safety of implementing a robotic telesurgery program in a tertiary academic referral center. Adult patients scheduled for elective robotic procedures, like radical prostatectomy or colectomy . Surgical procedures will be performed using the Toumai robotic surgical system. During predefined operative steps, a remote console surgeon located at Gemelli Isola Hospital will perform selected surgical tasks, while the primary console surgeon, the patient, and the entire operating room team remain at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The local surgeon can immediately resume control of the robotic system whenever required. First objective is to assess the feasibility and safety of telesurgery by evaluating the rate of conversion from remote to local robotic surgery. Other objectives include assessment of network performance, technical reliability, perioperative outcomes, and user and patient satisfaction.
Telesurgery is an emerging application of robotic-assisted surgery that enables surgeons to perform selected operative tasks remotely through advanced robotic systems and secure telecommunication technologies. Recent advances in robotic platforms, high-speed network infrastructures, and low-latency connectivity have renewed interest in the clinical implementation of telesurgery. Nevertheless, its adoption in routine clinical practice remains limited because further evidence regarding technical feasibility, safety, organizational requirements, and reproducibility is needed.
Consecutive adult patients eligible for robot-assisted procedures will be enrolled over a three-month recruitment period.
All procedures will be performed at Fondazione Policlinico Universitario Agostino Gemelli IRCCS using the Toumai robotic surgical platform. The patient, bedside surgical team, and primary console surgeon will remain at the Gemelli Hospital throughout the procedure. During predefined surgical phases, a second console surgeon located at Gemelli Isola Hospital will remotely perform selected operative steps. A dedicated network infrastructure with redundant dark-fiber connections, encrypted communication, and predefined latency thresholds has been implemented to ensure secure and reliable data transmission. Whenever considered necessary because of technical issues or surgical judgment, the local console surgeon can immediately resume direct control of the robotic system according to predefined safety protocols.
The primary endpoint is the conversion rate from remote telesurgical control to local robotic surgery during the telesurgical phases of the operation. Secondary endpoints include assessment of technical performance, network latency and reliability, intraoperative and postoperative outcomes, device-related malfunctions, and user and patient satisfaction. The study is intended to generate clinical and organizational evidence supporting the safe implementation of robotic telesurgery in routine surgical practice.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing robot-assisted telesurgery, with the operating surgeon located at a remote hospital site while the patient undergoes the procedure at the referral center.
Device: Robot-Assisted Telesurgery
Robot-assisted telesurgery performed using the Toumai robotic surgical system. Patients undergo robotic surgery at Fondazione Policlinico Gemelli IRCCS. The surgical procedure is initiated and completed by the local surgical team, while one or more predefined surgical steps are performed remotely by a second console surgeon located at Isola Tiberina Hospital. At any time during the procedure, the local console surgeon can immediately resume control of the robotic system if required.
Conversion Rate from Remote to Local Robotic Surgery (%)
Rate (%) of conversion from remote robotic surgery to completion of the procedure by the local console surgeon without further remote surgical involvement (due to unintended/urgent/emergency issues)
Time frame: Intraoperatively
Rate of Intraoperative Adverse Events
Occurrence and severity of intraoperative adverse events graded according to the Satava grading system and ICARUS classification.
Time frame: Intraoperatively
Postoperative Complications
Postoperative complications graded according to the Clavien-Dindo classification.
Time frame: Up to 30 post-operative days
Network Latency (msec)
Mean network latency recorded during the entire surgical procedure and during each surgical step.
Time frame: Intraoperatively
Rate of Technical Malfunctions
Number and type of technical malfunctions, including alarms, collisions, and deviations from the planned surgical strategy.
Time frame: Intraoperatively
Length of Hospital Stay (day)
Length of postoperative hospital stay.
Time frame: Time (days) up to hospital discharge
Plan to share: No
Start is estimated for Aug 2026; primary completion for Nov 2026, 3 months later.
Of 1,098 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 86. This study's planned 3 months is below that.
Counting every sponsor, half of 1,155 studies reached it within 43 months; a quarter within 22 and three quarters within 84.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS →