ymph node surgery using a radioactive tracer in prostatecancer patients with lymph node involvement

Phase 1

• Conditions: Patients diagnosed with prostate cancer upon prostate biopsy, who are suspected of having lymph node involvement based upon PSMA-PET/CT.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-003284-21-NL
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-02
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 20

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.

Study & Design

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