Radio guided lymph node dissection in oligo metastatic prostate cancer patients

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

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 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. (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.)
Age>=50 years.
Ability to give voluntary written informed consent to participate in this
study.

Exclusion Criteria

No detectable lesion on the 68Ga/18F-PSMA-PET/CT with an uptake level above
liver uptake level.
Patients who are not scheduled for PLND.
Prior pelvic surgery assosiated with pelvic lymphadenopathy.
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 surgery, radio-, hormonal- or
chemotherapy.
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 would
confound the results of this study, according to the investigators.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary aim of this study is to evaluate the feasibility of 111In-PSMA-I&T<br /><br>radio guided surgery in patients diagnosed with prostate cancer who are highly<br /><br>suspected of having one or more pelvic lymph node metastasis/metastases based<br /><br>on pre-operative imaging. Feasibility will be defined as the ability to<br /><br>intra-operatively detect the lymph nodes (using a gamma probe) which were<br /><br>pre-operatively identified on PSMA-PET/CT. </p><br>

Secondary Outcome Measures