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New treatment option for Cancer of Prostate
Official title Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention
ClinicalTrials.gov ID: NCT06318559
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 99, men only
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility criteria
- 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
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Candiolo, Turin, Italy
- Orbassano, Turin, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 40 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Candiolo, Turin, Italy; Orbassano, Turin, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.