EUCTR2019-003284-21-NLActive, not recruitingPhase 1
Radio guided lymph node dissection in oligo metastatic prostate cancer patients; a feasibility study - DETECT
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Radboudumc
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Male
Inclusion Criteria
- •?Histological proven cancer of the prostate, based on prostate biopsy-core analysis.
- •?At least one 68Ga/18F-PSMA-PET/CT positive metastasis in lymph nodes, located in pelvis.
- •?Patient is scheduled and fit for surgery (PLND or prostatectomy +PLND).
- •?Patient is suitable for PLND (and radical prostatectomy) conform institutional guidelines and is not yet treated pre-operatively.
- •?Age>18 years.
- •?Signed informed consent
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
- •?No detectable lesion on the 68Ga/18F-PSMA-PET/CT with an uptake level below liver uptake level.
- •?Patients who are not scheduled for PLND.
- •?Unequivocal evidence of metastases outside the pelvis.
- •?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 in the form of radio-, hormonal- or chemotherapy.
- •?Laboratory values at baseline:
- •-White blood cells < 3.5 *109/L
- •-Platelet count < 150*109/L
- •-Haemoglobin < 6 mmol/L
- •-ASAT, ALAT > 3 ULN
- •-GFR < 60 ml/min
- •?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 30 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 would confound the results of this study, according to the investigators.
Investigators
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