EUCTR2020-003183-68-IT
Active, not recruiting
Phase 1
The Role of Imaging Guided Surgery to Improve the Detection of LymphNode metastases in Prostate Cancer Patients Treated with Radical Prostatectomy and Extended Pelvic Lymph Node Dissection - PSMA-RGS
OSPEDALE SAN RAFFAELE0 sites100 target enrollmentJune 15, 2021
ConditionsPatients with prostate cancer (PCa) who are candidate to undergo surgical treatment with robot-assisted radical prostatectomy with a risk of lymph nodal invasion > 5% according to preoperative dataMedDRA version: 21.1Level: LLTClassification code 10026389Term: Malignant neoplasm of prostateSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with prostate cancer (PCa) who are candidate to undergo surgical treatment with robot-assisted radical prostatectomy with a risk of lymph nodal invasion > 5% according to preoperative data
- Sponsor
- OSPEDALE SAN RAFFAELE
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Male patients
- •\-Age between 18 and 80 years
- •\-Biopsy proven PCa with a LNI risk \>5% according to the Briganti nomogram
- •\-Planned to receive a RARP with an ePLND
- •\-Able to understand and willing to sign a written informed consent document
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 50
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •\-Receipt of neoadjuvant therapies
- •\-Inability to complete the imaging examinations according to the prospective protocol
- •\-Evidence of metastatic disease at conventional imaging before surgery
- •\-Evidence of clinical lymphadenopathies at conventional imaging before surgery
- •\-Life expectancy of less than 12 months
- •\-Previous chemotherapy
- •\-Previous brachytherapy or external beam radiotherapy
- •\-Unstable cardiovascular disease
- •\-Congestive Heart Failure (CHF)
- •\-Clinically significant hepatobiliary or renal disease
Outcomes
Primary Outcomes
Not specified
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