Prostatic Neoplasm Clinical Trial
Official title:
A Phase III Prospective Randomized Trial to Evaluate the Impact of Augmented Reality During Robot-assisted Radical Prostatectomy on the Rates of Postoperative Surgical Margins
Accurate preservation of neuro-vascular bundles is crucial in guaranteeing erectile function recovery after robot assisted radical prostatectomy (RARP). However, the nerve sparing approach is associated with higher rates of positive surgical margins (PSM) at final pathology. Augmented reality (AR) RARP was previously associated with a 10-15% reduction in the rates of PSMs in two retrospective series. However, prospective studies are needed to demonstrate clinical utility and to validate these technologies. The hypotheses of this study are that: 1) AR RARP reduces the rates of PSMs, if compared to standard approach; 2) AR RARP can guarantee a more accurate preservation of neurovascular bundles and, in consequence, a greater recovery of erectile function; 3) the lower rates of PSMs will translate in greater oncological control of the disease.
Status | Recruiting |
Enrollment | 318 |
Est. completion date | January 1, 2026 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: Untreated, biopsy-proven adenocarcinoma of the prostate Age =18 years European Association of Urology (EAU) low or intermediate risk prostate cancer: - PSA=20 ng/ml - cT=2b - International Society for Urological Pathology [ISUP] grade group=III Written informed consent provided for participation in the trial International Index of Erectile Function-5 (IIEF-5)=20 No contraindications for multiparametric magnetic resonance imaging (mpMRI) Exclusion Criteria: Any prior therapy for prostate cancer European Association of Urology (EAU) high risk prostate cancer: - PSA>20 ng/ml or - cT>2b or - ISUP grade group>III International Index of Erectile Function-5 (IIEF-5)<20 Prostate cancer with sarcomatoid or spindle cell or neuroendocrine small cell components Morbidity that would limit compliance with study protocols Controindications to perform mpMRI |
Country | Name | City | State |
---|---|---|---|
Italy | European Institute of Oncology | Milan |
Lead Sponsor | Collaborator |
---|---|
European Institute of Oncology |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Positive surgical margins | Pathological examination of positive surgical margins according to the criteria of the prostate consensus working group | Time zero | |
Secondary | Surgical time | Total operative time (mins) will we measured from skin incision to skin closure | Time zero | |
Secondary | Nerve-sparing approach | Rates of nerve-sparing approaches between groups will be evaluated according to the Tewari et al. scale | Time zero | |
Secondary | Erectile function | Erectile function recovery will be measured with the International Index of Erectile Function-5 questionnaire | 3-6-12 months after surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03982095 -
Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer
|
||
Recruiting |
NCT05667636 -
Early Salvage Stereotactic Radiotherapy for Biochemical Failure After RP
|
Phase 2 | |
Terminated |
NCT01996696 -
Prevention of Metabolic Syndrome and Increased Weight Using Metformin Concurrent to Androgen Deprivation Therapy and Radiotherapy for Locally Advanced Adenocarcinoma of the Prostate
|
Phase 2 | |
Completed |
NCT01431391 -
Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer
|
Phase 2 | |
Completed |
NCT03289130 -
Dietary Factors and Racial Disparities in Prostate Cancer Aggressiveness
|
||
Recruiting |
NCT04462926 -
Evaluation of Diagnostic Accuracy of [68Ga]Ga-PSMA-11 PET/CT in Primary Staging of Intermediate and High Risk Prostatic Cancer in Men Newly Diagnosed
|
N/A | |
Completed |
NCT00001446 -
A Randomized Phase II Study of Oral Thalidomide in Patients With Hormone-Refractory Prostate Cancer
|
Phase 2 | |
Completed |
NCT02729103 -
Treatment Patterns in Metastatic Prostate Cancer
|
N/A | |
Completed |
NCT00956228 -
Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT00126854 -
High Field Magnetic Resonance Spectroscopy Imaging for Follow Up of Prostate Cancer Post Brachytherapy Implantation
|
N/A | |
Completed |
NCT00247312 -
Pd-103 Dose De-Escalation for Early Stage Prostate Cancer: A Prospective Randomized Trial
|
Phase 3 | |
Completed |
NCT00174863 -
Evaluation of SR 31747A Versus Placebo in Androgen-Independent Non Metastatic Prostate Cancer
|
Phase 2 | |
Terminated |
NCT04221828 -
Trial of NanoPac Focal Therapy for Prostate Cancer
|
Phase 2 | |
Completed |
NCT00001266 -
A Phase II Trial of Leuprolide + Flutamide + Suramin in Untreated Poor Prognosis Prostate Carcinoma
|
Phase 2 | |
Active, not recruiting |
NCT03935282 -
Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors
|
N/A | |
Completed |
NCT03693742 -
MSG Use With 18F-DCFPyL PET/CT Imaging
|
N/A | |
Recruiting |
NCT06236789 -
Observation Study to Evaluate the Efficacy and Safety of Ifosfamide/Mesna in Patients With Metastatic Castration-resistant Prostate Cancer
|
||
Completed |
NCT02977143 -
Positive End-expiratory Pressure-induced Increase in Central Venous Pressure as a Predictor of Fluid Responsiveness in Robot-assisted Laparoscopic Surgery
|
N/A | |
Completed |
NCT02966535 -
The Effect of Prolonged Inspiratory Time on Gas Exchange During Robot-assisted Laparoscopic Surgery With Steep Trendelenburg Position : A Crossover Randomized Clinical Trial
|
N/A | |
Completed |
NCT00252460 -
CT/MRI Co-registration Prostate Cancer
|
Phase 1 |