Status:
UNKNOWN
Radio Guided Lymph Node Dissection in Oligometastatic Prostate Cancer Patients
Lead Sponsor:
Radboud University Medical Center
Conditions:
Prostate Cancer
Lymph Node Metastases
Eligibility:
MALE
50+ years
Phase:
PHASE1
PHASE2
Brief Summary
The study is a prospective, single arm phase I/II study. The primary aim of this study is to evaluate the feasibility of 111In-PSMA I\&T radio guided surgery in patients diagnosed with prostate cancer...
Eligibility Criteria
Inclusion
- Histologically proven cancer of the prostate, based on prostate biopsy-core analysis.
- At least one 18F/68Ga-PSMA-PET/CT suspected positive metastasis in lymph nodes, located in the pelvic region.
- Patient is scheduled and fit for robot assisted surgery (PLND or radical prostatectomy +PLND).
- Patient is suitable for PLND (and radical prostatectomy) conform institutional guidelines and is not yet treated pre-operatively .
- Age≥50 years.
- Ability to give voluntary written informed consent to participate in this study.
Exclusion
- No detectable lesion on the 18F/68Ga-PSMA-PET/CT with an uptake level above liver uptake level (reference).
- Patients who are not scheduled for robot-assisted PLND.
- Prior pelvic surgery(1)
- Unequivocal evidence of metastases outside the pelvic region.
- Presence of any medical condition that in the opinion of the investigator/treating physician will affect patients' clinical status by participating in this trial.
- Prior prostate cancer treatment(2).
- Contraindication for MRI-scanning, i.e. claustrophobia, intracranial metal clips, metallic bodies in the eye, implanted electric and electronic devices not eligible for MRI (pacemakers, insulin pumps, cochlear implants, neurostimulators).
- Inability to lie still for at least 60 minutes or comply with imaging.
- Contraindication for iron infusion or hypersensitivity/allergy to the active substance or any of the excipients.
- The patient is already enrolled in one or more concurrent studies, which could confound the results of this study, according to the investigators.
- Pelvic surgery is defined as "any surgery associated with pelvic lymphadenopathy'.
- Prior prostate cancer treatment is defined as prostate and/or pelvic radiotherapy, hormonal treatments such as androgen deprivation therapy, prostate brachytherapy, prostate cryotherapy, high intensity focused ultrasound (HIFU) and/or prostate electroporation.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04300673
Start Date
September 1 2020
End Date
April 1 2023
Last Update
April 29 2022
Active Locations (2)
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1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6525
2
Canisius Wilhelimina Ziekenhuis
Nijmegen, Netherlands