The implementation of imaging guidance in surgery for patients with prostate cancer who are candidate to undergo robot-assisted prostatectomy and lymph node removal

Phase 1

• 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; MedDRA version: 21.1Level: LLTClassification code 10026389Term: Malignant neoplasm of prostateSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2020-003183-68-IT
• Lead Sponsor: OSPEDALE SAN RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-15
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 100

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
F.1.3.1 Number of subjects for this age range 50

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
-History of significant CNS injuries within 6 months
-Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial
-Medical history of allergic disease or reactions likely to be exacerbated by the IMPs used in this study or by any of the components of the radiotracers (99mTc-PSMA-I&S and 68Ga-PSMA)
-Patients who received an experimental drug in the context of clinical trials within 30 days from the administration of the radiotracers in the current investigation or within 5 half-lives of the experimental drug itself

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified