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New treatment option for Prostate Cancer
Official title Robotic Hemi-Prostatectomy With Urethral Preservation in Low and Intermediate Risk Monolateral Prostate Cancer
ClinicalTrials.gov ID: NCT05832736
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older, men only
You may be able to join if
- 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...
- Histological diagnosis of acinar-type prostate cancer unilateral on target biopsy and/or standard biopsy with ISUP \< 3 and ipsilateral on imaging...
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
You likely can't join if
- 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
See the full eligibility criteria
- 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...
- 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
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Candiolo, TO, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Candiolo, TO, 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.