Prostate CancerNCT07610083
A Study Comparing Single-Port and Multi-Port Robot-Assisted Surgery in Patients With Prostate or Kidney (Renal) Cancer
An observational study of Prostate Cancer and Renal Cancer, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
This is a prospective single-center observational study comparing single-port (SP) and multi-port (MP) robot-assisted surgery in adult patients undergoing robot-assisted radical prostatectomy (RARP) or robot-assisted partial nephrectomy (RAPN) for prostate or kidney cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Renal Cancer
- How many people
- 376 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2026to Oct 2030
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male or female participants (≥18 years old) with a diagnosis of prostate or renal cancer candidates for RARP or RAPN.
Who may be able to join
- The participant provides written informed consent
- Male or female participants who are at least 18 years of age on the day of signing informed consent
- Men with a diagnosis of prostate or renal cancer and women with a diagnosis of renal cancer
- Pre-operative imaging performed for staging purposes (i.e. CT scan, PSMA PET) showing no suspicious evidence of distant metastases in prostate or renal cancer patients
- Suitable for RARP or RAPN.
Who cannot join
- Patients < 18 years
- Mental or physical disability that may prevent the patient from satisfying the requirements of the protocol
- Inability to read and sign the informed consent
- No available pre-operative staging
- Contraindication to surgery
- Presence of distant metastases (M1)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Single-port vs. Multi-port Robot-assisted Surgery for Prostate or Renal Cancer
This is a prospective single-center observational study comparing single-port (SP) and multi-port (MP) robot-assisted surgery in adult patients undergoing robot-assisted radical prostatectomy (RARP) or robot-assisted partial nephrectomy (RAPN) for prostate or kidney cancer.
Consecutive eligible patients will be managed according to routine clinical practice and assigned to SP or MP surgery based on predefined clinical and anatomical criteria, surgeon assessment, patient and tumor characteristics, platform availability, and surgical expertise. No randomization will be performed.
Read more
The study aims to compare perioperative outcomes between the two surgical approaches, with length of hospital stay (LOS) as the primary endpoint. Secondary endpoints include intraoperative outcomes (operative time, estimated blood loss, and intraoperative complications), postoperative recovery, pain, postoperative complications, readmission rates, positive surgical margins, and hospital costs.
Functional and patient-reported outcomes will also be evaluated, including urinary continence, sexual function, health-related quality of life, renal function after partial nephrectomy, decision regret, and cosmetic satisfaction.
Read the detailed description
This prospective observational cohort study is conducted at a single high-volume tertiary referral center performing robot-assisted urologic surgery using both single-port (SP) and multi-port (MP) robotic platforms.
The study includes consecutive adult patients (≥18 years) undergoing robot-assisted radical prostatectomy (RARP) or robot-assisted partial nephrectomy (RAPN) for prostate or kidney cancer during the study period.
Treatment allocation is not randomized. The choice between SP and MP surgery is made in routine clinical practice by the treating surgeon based on predefined clinical and anatomical criteria, including patient characteristics, tumor features, surgical indication, platform availability, and surgeon experience.
The primary objective is to compare perioperative outcomes between SP and MP robotic-assisted surgery, with length of hospital stay (LOS) defined as the primary endpoint. LOS is measured from the end of surgery (skin closure) to hospital discharge according to standardized discharge criteria.
Secondary outcomes include intraoperative parameters (operative time, estimated blood loss, intraoperative complications), postoperative recovery assessed by validated measures, pain scores, postoperative complications graded by Clavien-Dindo classification, readmission rates, positive surgical margins, and total hospital-related costs.
Additional secondary outcomes include functional outcomes after RARP (urinary continence, sexual function, and health-related quality of life), renal function after RAPN (estimated glomerular filtration rate), decision regret, and cosmetic satisfaction and body image perception.
All outcomes are collected prospectively according to predefined time points within routine follow-up schedules.
- Conditions
- Prostate Cancer, Renal Cancer
- Medical subject headings
- Prostatic Neoplasms, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single-Port Robot-Assisted Surgery | Not described | |
| Multi-Port Robot-Assisted Surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay (LOS)
Length of hospital stay (LOS), defined as the time from the end of surgery (skin closure) to hospital discharge, expressed in days or hours. Discharge will be based on predefined and standardized discharge criteria.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study startOct 2026 (estimated)
- Primary completionNov 2029 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Montorsi, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610083
- Sponsor's protocol ID
- PORTAL Study
- Status last verified
- Sep 2026
- First submitted
- 20 May 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-port vs. Multi-port Robot-assisted Surgery for Prostate or Renal Cancer
- ClinicalTrials.gov ID
- NCT07610083
- Acronym / sponsor ID
- PORTAL Study
- Conditions
- Prostate Cancer, Renal Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 27 May 2026 (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 single-center observational study comparing single-port (SP) and multi-port (MP) robot-assisted surgery in adult patients undergoing robot-assisted radical prostatectomy (RARP) or robot-assisted partial nephrectomy (RAPN) for prostate or kidney cancer.
Consecutive eligible patients will be managed according to routine clinical practice and assigned to SP or MP surgery based on predefined clinical and anatomical criteria, surgeon assessment, patient and tumor characteristics, platform availability, and surgical expertise. No randomization will be performed.
The study aims to compare perioperative outcomes between the two surgical approaches, with length of hospital stay (LOS) as the primary endpoint. Secondary endpoints include intraoperative outcomes (operative time, estimated blood loss, and intraoperative complications), postoperative recovery, pain, postoperative complications, readmission rates, positive surgical margins, and hospital costs.
Functional and patient-reported outcomes will also be evaluated, including urinary continence, sexual function, health-related quality of life, renal function after partial nephrectomy, decision regret, and cosmetic satisfaction.
Detailed description
This prospective observational cohort study is conducted at a single high-volume tertiary referral center performing robot-assisted urologic surgery using both single-port (SP) and multi-port (MP) robotic platforms.
The study includes consecutive adult patients (≥18 years) undergoing robot-assisted radical prostatectomy (RARP) or robot-assisted partial nephrectomy (RAPN) for prostate or kidney cancer during the study period.
Treatment allocation is not randomized. The choice between SP and MP surgery is made in routine clinical practice by the treating surgeon based on predefined clinical and anatomical criteria, including patient characteristics, tumor features, surgical indication, platform availability, and surgeon experience.
The primary objective is to compare perioperative outcomes between SP and MP robotic-assisted surgery, with length of hospital stay (LOS) defined as the primary endpoint. LOS is measured from the end of surgery (skin closure) to hospital discharge according to standardized discharge criteria.
Secondary outcomes include intraoperative parameters (operative time, estimated blood loss, intraoperative complications), postoperative recovery assessed by validated measures, pain scores, postoperative complications graded by Clavien-Dindo classification, readmission rates, positive surgical margins, and total hospital-related costs.
Additional secondary outcomes include functional outcomes after RARP (urinary continence, sexual function, and health-related quality of life), renal function after RAPN (estimated glomerular filtration rate), decision regret, and cosmetic satisfaction and body image perception.
All outcomes are collected prospectively according to predefined time points within routine follow-up schedules.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-Port Robot-Assisted Surgery | – | – |
| Multi-Port Robot-Assisted Surgery | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female participants (≥18 years old) with a diagnosis of prostate or renal cancer candidates for RARP or RAPN.
Key inclusion criteria (5 listed)
- The participant provides written informed consent
- Male or female participants who are at least 18 years of age on the day of signing informed consent
- Men with a diagnosis of prostate or renal cancer and women with a diagnosis of renal cancer
- Pre-operative imaging performed for staging purposes (i.e. CT scan, PSMA PET) showing no suspicious evidence of distant metastases in prostate or renal cancer patients
- Suitable for RARP or RAPN.
Key exclusion criteria (6 listed)
- Patients < 18 years
- Mental or physical disability that may prevent the patient from satisfying the requirements of the protocol
- Inability to read and sign the informed consent
- No available pre-operative staging
- Contraindication to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Length of hospital stay (LOS)
Time frame: Day 30
Length of hospital stay (LOS), defined as the time from the end of surgery (skin closure) to hospital discharge, expressed in days or hours. Discharge will be based on predefined and standardized discharge criteria.
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 15 Sep 2026.
Related trials for Prostate Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Renal Cancer, run by IRCCS San Raffaele at 1 site 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 5 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: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (LOS) (time frame: Day 30). 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 15 Sep 2026.