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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with unilateral prostate cancer | Experimental | Patients with unilateral prostate cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic hemi-prostatectomy with urethral preservation | Procedure | Robotic hemi-prostatectomy with urethral preservation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Porpiglia | Contact | +39 011 9933921 | francesco.porpiglia@unito.it |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Porpiglia | Fondazione del Piemonte per l'Oncologia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione del Piemonte per l'Oncologia | Recruiting | Candiolo | TO | 10060 | Italy |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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. | 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. | 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. | 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). | 5 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |