Prostate CancerRETURNNCT05832736
Robotic Hemi-Prostatectomy With Urethral Preservation in Low and Intermediate Risk Monolateral Prostate Cancer
A study testing Robotic hemi-prostatectomy with urethral preservation in people with Prostate Cancer, run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
Trial summary
On the basis of the now consolidated literature and clinical experience of focal therapies, the execution of partial prostatectomy/hemiprostatectomy with robot-assisted laparoscopic technique can be proposed in a well-selected cohort of patients. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Robotic hemi-prostatectomy with urethral preservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 12 Apr 2023to Oct 2028
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signature of the informed consent and consent to the use of personal data
- Prostate Specific Antigen (PSA) < 20 ng/mL
- Unilateral organ-confined disease on MRI (performed according to ESUR recommendations and reported according to PiRads V.2) or PET-PSMA (performed according to the recommendations of the EANM and reported according to "EANM standardized reporting guidelines v1.0 for PSMA-PET")
- Histological diagnosis of acinar-type prostate cancer unilateral on target biopsy and/or standard biopsy with ISUP < 3 and ipsilateral on imaging investigations
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Life expectancy ≥ 5 years
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- Availability of the patient's pre-operative clinical data
- Patients must be available to carry out the follow-up visits defined by the protocol
- Absence of retroperitoneal, lymph nodal, bone or visceral metastatic lesions
- Patients eligible for robot-assisted radical prostatectomy
Who cannot join
- Special histotypes of prostate cancer
- Patients with PSA > 20 ng/ml at diagnosis
- Impossibility to perform MRI (with pacemakers, claustrophobia…) or PET-PSMA
- Previous prostate surgery (TURP, adenomectomy)
- Concomitant treatment with other antineoplastic drugs including investigational endocrine therapies
- Serious underlying disease or uncontrolled medical condition including active and uncontrolled infections
- Patients with dementia or psychiatric illness that limit compliance with study requirements or that could prevent understanding and/or signing the informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione del Piemonte per l'Oncologia
Candiolo, TO, 10060
Enrico Checcucci, +39 011 9933921, checcu.e@hotmail.it
About this study
Official title: Robotic Hemi-Prostatectomy With Urethral Preservation in Low and Intermediate Risk Monolateral Prostate Cancer: a Prospective Idea, Development, Exploration, Assessment and Long-term Follow-up (I.D.E.A.L.) Trial
On the basis of the now consolidated literature and clinical experience of focal therapies, the execution of partial prostatectomy/hemiprostatectomy with robot-assisted laparoscopic technique can be proposed in a well-selected cohort of patients.
The hypothesis is that with this technique it is possible to achieve excellent levels of disease control, in terms of positive surgical margins (PSM) and biochemical recurrence of the disease (BCR), against a minimal impact as regards postoperative functional outcomes (continence and sexual power).
- Conditions
- Prostate Cancer
- Being tested
- Robotic hemi-prostatectomy with urethral preservation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic hemi-prostatectomy with urethral preservationProcedure or surgery
Also called Partial prostatectomy
Robotic hemi-prostatectomy with urethral preservation
| Study group | Role | What they receive |
|---|---|---|
| Patients with unilateral prostate cancer | Experimental | Patients with unilateral prostate cancer Receives: Procedure: Robotic hemi-prostatectomy with urethral preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the robotic hemiprostatectomy technique
Evaluate the feasibility of the robotic hemiprostatectomy technique in both a preclinical and clinical setting as ratio between the number of hemiprostatectomies completed and the total number of prostatectomies performed
Measured: Baseline
Secondary outcomes (5)
Safety of the robotic hemiprostatectomy technique
Evaluate the safety of the robotic hemiprostatectomy technique in terms of intra and post-operative complications using the Clavien-Dindo classification.
The Clavien-Dindo classification evaluates severity of complications in 5 groups:
- Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions;
- Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications;
- Grade III: Requiring surgical, endoscopic or radiological intervention (IIIa: Intervention not under general anesthesia; IIIb: Intervention under general anesthesia);
- Grade IV Life-threatening complication requiring IC/ICU-management (IVa: single organ dysfunction; IVb: multiorgan dysfunction);
- Grade V: Death of a patient.
Measured: 30 days
Positive Surgical Margins (PSMs) rate
Evaluate the oncological efficacy in terms of Positive Surgical Margins (PSMs) at the final histological examination as rate between cases with Positive Surgical Margins over the total of the specimens analyzed by pathologists.
Measured: 30 days
Biochemical Recurrence (BCR) rate
Evaluate the oncological efficacy in terms of Biochemical Recurrence (BCR) during the follow-up period as rate between patients with BCR over the total of patients in the study group.
The BCR is any rise in the blood level of PSA (prostate-specific antigen) in prostate cancer patients after treatment with surgery or radiation.
Measured: 5 years
Urinary continence after surgery
Evaluate the functional outcomes in terms of urinary continence during the follow-up period.
The urinary continence will be assessed by the net weight of urine collected in the pad over 24 hours (Pad test).
This outcome will be shown by the mont after the surgery in which the patient reach the complete continence defined as no urine loss at the Pad test.
Measured: 5 years
Potency recovery after surgery
Evaluate the functional outcomes in terms of potency recovery during the follow-up period.
The potency recovery will be assessed by the International Index of Erectile Function - 5 (IIEF-5) test. This test will be collected every follow-up visit and results will be shown as progression of the IIEF-5 during the 5 years after the surgery.
The IIEF-5 contains 5 items and uses the sum scores and cutoff points to categorize the severity of the erectile dysfunction. This scale ranges from 5 points (severe erectile dysfunction) to 25 points (no erectile dysfunction).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start12 Apr 2023
- Primary completionOct 2023 (estimated)
- Study completionOct 2028 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Porpiglia, Fondazione del Piemonte per l'Oncologia
- Investigators
- Francesco Porpiglia, Principal investigator, Fondazione del Piemonte per l'Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832736
- Sponsor's protocol ID
- IRCC 15/2023
- Acronym
- RETURN
- Status last verified
- Sep 2023
- First submitted
- 3 Apr 2023
- Last updated
- 26 Sep 2023
- 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 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Hemi-Prostatectomy With Urethral Preservation in Low and Intermediate Risk Monolateral Prostate Cancer: a Prospective Idea, Development, Exploration, Assessment and Long-term Follow-up (I.D.E.A.L.) Trial
- ClinicalTrials.gov ID
- NCT05832736
- Acronym / sponsor ID
- RETURN / IRCC 15/2023
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Fondazione del Piemonte per l'OncologiaUniversity, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 27 Apr 2023 (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.
On the basis of the now consolidated literature and clinical experience of focal therapies, the execution of partial prostatectomy/hemiprostatectomy with robot-assisted laparoscopic technique can be proposed in a well-selected cohort of patients.
The hypothesis is that with this technique it is possible to achieve excellent levels of disease control, in terms of positive surgical margins (PSM) and biochemical recurrence of the disease (BCR), against a minimal impact as regards postoperative functional outcomes (continence and sexual power).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with unilateral prostate cancer | Experimental | Procedure: Robotic hemi-prostatectomy with urethral preservationPatients with unilateral prostate cancer |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signature of the informed consent and consent to the use of personal data
- Prostate Specific Antigen (PSA) < 20 ng/mL
- Unilateral organ-confined disease on MRI (performed according to ESUR recommendations and reported according to PiRads V.2) or PET-PSMA (performed according to the recommendations of the EANM and reported according to "EANM standardized reporting guidelines v1.0 for PSMA-PET")
- Histological diagnosis of acinar-type prostate cancer unilateral on target biopsy and/or standard biopsy with ISUP < 3 and ipsilateral on imaging investigations
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Key exclusion criteria (7 listed)
- Special histotypes of prostate cancer
- Patients with PSA > 20 ng/ml at diagnosis
- Impossibility to perform MRI (with pacemakers, claustrophobia…) or PET-PSMA
- Previous prostate surgery (TURP, adenomectomy)
- Concomitant treatment with other antineoplastic drugs including investigational endocrine therapies
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 |
|---|---|---|
| Robotic hemi-prostatectomy with urethral preservationAlso: Partial prostatectomyRobotic hemi-prostatectomy with urethral preservation | Procedure or surgery | Patients with unilateral prostate cancer |
Primary outcome
Feasibility of the robotic hemiprostatectomy technique
Time frame: Baseline
Evaluate the feasibility of the robotic hemiprostatectomy technique in both a preclinical and clinical setting as ratio between the number of hemiprostatectomies completed and the total number of prostatectomies performed
5 secondary outcomes
Safety of the robotic hemiprostatectomy technique
Time frame: 30 days
Positive Surgical Margins (PSMs) rate
Time frame: 30 days
Biochemical Recurrence (BCR) rate
Time frame: 5 years
Urinary continence after surgery
Time frame: 5 years
Potency recovery after surgery
Time frame: 5 years
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 26 Sep 2023.
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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.
Francesco Porpiglia principal investigator
Fondazione del Piemonte per l'Oncologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic hemi-prostatectomy with urethral preservation in people with Prostate Cancer, run by Fondazione del Piemonte per l'Oncologia 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 10 inclusion and 7 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 26 Sep 2023. 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?
Contact Francesco Porpiglia (+39 011 9933921, francesco.porpiglia@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the robotic hemiprostatectomy technique (time frame: Baseline). 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 26 Sep 2023.