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The implementation of imaging guidance in surgery for patients with prostate cancer who are candidate to undergo robot-assisted prostatectomy and lymph node removal
EU CTIS ID: 2024-514583-12-00
What this study is testing
The objective of the study is to improve clinicians’ ability to identify LNI in PCa patients undergoing RARP with an ePLND and to assess the role of 99mTc-PSMA-I&S in this setting.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Receipt of neoadjuvant therapies
- 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
See the full eligibility 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
- Receipt of neoadjuvant therapies
- 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
- 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)
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.