Cancer of ProstateRIDERSNCT06318559
Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention
A study testing 3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy in people with Cancer of Prostate, run by Fondazione del Piemonte per l'Oncologia at 2 sites in Italy.
Trial summary
This is a prospective randomized multicenter study aimed at comparing 3D AI-AR-RARP vs. no 3D, verifying the impact of this new technology on oncological and functional outcomes after the procedure. Read more about this study
- Who is it for?
- Ages 40 to 99 years, men only
- Conditions the study is for
- Cancer of Prostate
- What is being tested?
- 3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesItaly
- Study dates
- 29 Jun 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signature of the written informed consent and consent to the use of personal data
- Age > 40 years and male sex
- Pre-operative MRI performed according to ESUR recommendations and reporting in accordance with PiRads V.2
- Disease with evidence of bulging or radiological T3 on pre-operative MRI
- Histological diagnosis of acinar type prostate cancer in the area highlighted on MRI
- Absence of bulky (>3 cm), bony or visceral retroperitoneal or pelvic lymph node metastatic lesions
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- Patients eligible for radical prostatectomy + pelvic lymphadenectomy
- ECOG PS 0-1
- Life expectancy ≥ 5 years
- Patients motivated to preserve erection and with pre-operative sexual activity with IIEF >17
- Availability of the patient's pre-operative clinical data
- Patients must be available to carry out the visits foreseen in the follow-up of the protocol and consent to data collection
Who cannot join
- Special histotypes of prostate cancer
- Patients with PSA > 100 ng/ml at diagnosis
- Inability to perform MRI (pacemaker wearers, claustrophobia...) or MRI of inadequate quality to obtain the HA3DTM 3D reconstruction
- Concomitant treatment with other antineoplastic drugs including investigational endocrine therapies
- Serious uncontrolled concomitant medical condition or disease including active, uncontrolled infections
- Patients with dementia or psychiatric illness that limit compliance with study requirements or that may prevent understanding and/or signing informed consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
Candiolo, Turin, 10060
Enrico Checcucci, MD, +390119933632, enrico.checcucci@ircc.it
- Recruiting
AOU san Luigi Gonzaga
Orbassano, Turin, 10060
Francesco Porpiglia, MD
About this study
Official title: RIDERS: Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention: a Prospective Multicenter Randomized Controlled Trial
This is a prospective randomized multicenter study aimed at comparing 3D AI-AR-RARP vs. no 3D, verifying the impact of this new technology on oncological and functional outcomes after the procedure.
Read the detailed description
Considering that prostate cancer lesions are not identifiable during surgery, except in the case of extensive and advanced tumors, the surgeon does not have a real-time perception of the location of the tumor. The absence of clear spatial visualization can therefore lead to a positive surgical margin, particularly in tumors in the T3 stage (invasion of the prostatic capsule or seminal vesicles).
Our hypothesis is that with the help of AI 3D AR during surgery, positive surgical margins can be avoided, or at least reduced, while preserving the neurovascular bundles, with a consequent improvement not only in postoperative functional outcomes (continence and potency), but also oncological ones (less biochemical disease recovery (BCR), less need for salvage radiotherapy, lower risk of metastasis).
- Conditions
- Cancer of Prostate
- Being tested
- 3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy
- Keywords
- 3D AI-AR-RARP, Cancer of Prostate, prostate surgery, Hyper-Accuracy 3D reconstruction (HA3DTM), Riders, computer vision, Robot-assisted, laparoscopic radical prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomyProcedure or surgery
The operation is performed using the "Da Vinci HD" robotic system which allows the use of laparoscopic instruments, with greater mobility and the possibility of easier and more precise control of movements in three dimensions. Furthermore, the system allows the surgeon a three-dimensional view of the operating field. The surgery is performed under general anesthesia. Six or more trocars are positioned, into which the instruments operated by the robot or directly by the surgical assistants are inserted.
Then a radical prostatectomy is performed.
| Study group | Role | What they receive |
|---|---|---|
| 3D group | Experimental | in Group 3D, an intrafascial nerve-sparing (NS) technique will be performed on the side of the lesion; contralaterally an intra-, inter- or extra-fascial NS technique will be performed. After removal of the prostate, virtual images of the prostate will be projected into the lodge using AI software and will be displayed thanks to the Tile-Pro. The virtual 3D model will allow identifying the extracapsular extension of the tumor lesion, projected at the level of the preserved neurovascular bundle.
A first selective excisional biopsy at the level of the suspected ECE on the NVB will be sent for extemporaneous histological examination. Under 3D AR guidance, a second selective biopsy will then be performed on the NVB at the same level as the first, however involving a larger and thicker layer of tissue. the biopsies will be sent for extemporaneous histological examination. In case of positivity, the entire NVB will be removed Receives: Procedure: 3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy |
| no3D group | Active comparator | For the no-3D group, the intra-, inter- or extra-fascial NS technique during robotic prostatectomy will be performed according to the clinical indication.
At the end of the demolitive phase a selective biopsu was performed in a cognitive fashion accordin with the information provided by MRI images.
Reconstructive phase was performed according to our previously described total anatomical reconstruction (TAR) technique for both arms. Receives: Procedure: 3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative surgical oncological outcomes
Verify oncological outcomes in prostate cancer patients with evidence of bulging or extracapsular disease (ECE or rT3) on preoperative MRI, in terms of positive margin rate (PSM) following surgery
Measured: 12 months after surgery
Secondary outcomes (3)
Micturition outcomes
Evaluation of continence recovery rate. Continence was defined as use of 0-1 pads/die. Furthermore 24/h pad test was performed in case of persistence of incontinence to evaluate the different degree of urine losses, and was classified according to ICS definitions.
Measured: 5 years after surgery
Sexual function outcomes
Evaluation of erection recovery in terms of IIEF-5 (International Index of Erectile Function Questionnaire).
Measured: 5 years after surgery
Oncological outcomes
Evaluation of patients' oncological outcomes during the follow up in terms of biochemical recurrence (BCR) and occurrence of local/distant recurrence detected with different imaging techniques during the FU according to clinical indication
Measured: 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start29 Jun 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of ProstateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized using an Excel® macro in 2 group: 3D and no3D, stratifying them by age, PSA, cT, PSA density, prostate volume, lesion volume, extracapsular extension (ECE), seminal vesicle invasion (SVI), biopsy ISUP.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Sponsor type
- University, hospital or other
- Collaborators
- San Luigi Gonzaga Hospital
- Responsible party
- Sponsor
- Investigators
- Enrico Checcucci, MD, Principal investigator, Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318559
- Sponsor's protocol ID
- 027-FPO22
- Acronym
- RIDERS
- Status last verified
- Mar 2024
- First submitted
- 15 Feb 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RIDERS: Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention: a Prospective Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06318559
- Acronym / sponsor ID
- RIDERS / 027-FPO22
- Conditions
- Cancer of Prostate
- Keywords
- 3D AI-AR-RARP, Cancer of Prostate, prostate surgery, Hyper-Accuracy 3D reconstruction (HA3DTM), Riders, computer vision, Robot-assisted, laparoscopic radical prostatectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fondazione del Piemonte per l'OncologiaUniversity, hospital or other
- Collaborators
- San Luigi Gonzaga Hospital
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective randomized multicenter study aimed at comparing 3D AI-AR-RARP vs. no 3D, verifying the impact of this new technology on oncological and functional outcomes after the procedure.
Detailed description
Considering that prostate cancer lesions are not identifiable during surgery, except in the case of extensive and advanced tumors, the surgeon does not have a real-time perception of the location of the tumor. The absence of clear spatial visualization can therefore lead to a positive surgical margin, particularly in tumors in the T3 stage (invasion of the prostatic capsule or seminal vesicles).
Our hypothesis is that with the help of AI 3D AR during surgery, positive surgical margins can be avoided, or at least reduced, while preserving the neurovascular bundles, with a consequent improvement not only in postoperative functional outcomes (continence and potency), but also oncological ones (less biochemical disease recovery (BCR), less need for salvage radiotherapy, lower risk of metastasis).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized using an Excel® macro in 2 group: 3D and no3D, stratifying them by age, PSA, cT, PSA density, prostate volume, lesion volume, extracapsular extension (ECE), seminal vesicle invasion (SVI), biopsy ISUP.
| Arm | Type | Receives |
|---|---|---|
| 3D group | Experimental | Procedure: 3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomyin Group 3D, an intrafascial nerve-sparing (NS) technique will be performed on the side of the lesion; contralaterally an intra-, inter- or extra-fascial NS technique will be performed. After removal of the prostate, virtual images of the prostate will be projected into the lodge using AI software and will be displayed thanks to the Tile-Pro. The virtual 3D model will allow identifying the extracapsular extension of the tumor lesion, projected at the level of the preserved neurovascular bundle. A first selective excisional biopsy at the level of the suspected ECE on the NVB will be sent for extemporaneous histological examination. Under 3D AR guidance, a second selective biopsy will then be performed on the NVB at the same level as the first, however involving a larger and thicker layer of tissue. the biopsies will be sent for extemporaneous histological examination. In case of positivity, the entire NVB will be removed |
| no3D group | Active comparator | Procedure: 3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomyFor the no-3D group, the intra-, inter- or extra-fascial NS technique during robotic prostatectomy will be performed according to the clinical indication. At the end of the demolitive phase a selective biopsu was performed in a cognitive fashion accordin with the information provided by MRI images. Reconstructive phase was performed according to our previously described total anatomical reconstruction (TAR) technique for both arms. |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signature of the written informed consent and consent to the use of personal data
- Age > 40 years and male sex
- Pre-operative MRI performed according to ESUR recommendations and reporting in accordance with PiRads V.2
- Disease with evidence of bulging or radiological T3 on pre-operative MRI
- Histological diagnosis of acinar type prostate cancer in the area highlighted on MRI
Key exclusion criteria (6 listed)
- Special histotypes of prostate cancer
- Patients with PSA > 100 ng/ml at diagnosis
- Inability to perform MRI (pacemaker wearers, claustrophobia...) or MRI of inadequate quality to obtain the HA3DTM 3D reconstruction
- Concomitant treatment with other antineoplastic drugs including investigational endocrine therapies
- Serious uncontrolled concomitant medical condition or disease including active, uncontrolled infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomyThe operation is performed using the "Da Vinci HD" robotic system which allows the use of laparoscopic instruments, with greater mobility and the possibility of easier and more precise control of movements in three dimensions. Furthermore, the system allows the surgeon a three-dimensional view of the operating field. The surgery is performed under general anesthesia. Six or more trocars are positioned, into which the instruments operated by the robot or directly by the surgical assistants are inserted. Then a radical prostatectomy is performed. | Procedure or surgery | 3D group, no3D group |
Primary outcome
Perioperative surgical oncological outcomes
Time frame: 12 months after surgery
Verify oncological outcomes in prostate cancer patients with evidence of bulging or extracapsular disease (ECE or rT3) on preoperative MRI, in terms of positive margin rate (PSM) following surgery
3 secondary outcomes
Micturition outcomes
Time frame: 5 years after surgery
Sexual function outcomes
Time frame: 5 years after surgery
Oncological outcomes
Time frame: 5 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Enrico Checcucci, MD principal investigator
Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy in people with Cancer of Prostate, run by Fondazione del Piemonte per l'Oncologia at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enrico Checcucci, MD (+390119933632, enrico.checcucci@ircc.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative surgical oncological outcomes (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.