Status:
COMPLETED
Lutetium-177-PSMA-617 in Low Volume Metastatic Prostate Cancer
Lead Sponsor:
Radboud University Medical Center
Conditions:
Prostate Neoplasm
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Radioligand therapy (RLT) using Lu-177 labelled PSMA is a promising new therapeutic approach to treat metastatic prostate cancer. This tumor-specific treatment is directed against prostate-specific me...
Detailed Description
Radioligand therapy (RLT) is a promising new therapeutic approach to treat metastatic prostate cancer. This tumor-specific treatment is directed against prostate-specific membrane antigen (PSMA), whic...
Eligibility Criteria
Inclusion
- Histological proven adenocarcinoma of the prostate
- Prior local therapy for prostate cancer
- Biochemical recurrence or clinical progression after local therapy (PSA \> 0.2 µg/l),
- PSA-DT \< 6 months
- Gallium-68 (68Ga)-PSMA-PET-CT positive metastases in bones and/or lymph nodes (N1/M1ab): ≥1, maximally 10 metastases (at least 1 lesion with a lesion size of ≥1 cm to enable adequate dosimetry studies)
- Local treatment for oligo-metastases with radiotherapy or surgery appears to be no option anymore (due to prior treatment or the location of the metastatic lesions)
- No prior hormonal therapy or chemotherapy; testosteron \> 1.7 nmol/l. Exception: local prostate cancer treated with local radiotherapy plus adjuvant ADT; these patients need to be stopped with ADT at least 3 months
- No visceral metastases
- Laboratory values:
- White blood cells \> 3.5 x 109/l
- Platelet count \> 150 x 109/l
- Hemoglobin \> 6 mmol/l
- Alanine transaminase, aspartate aminotransferase \< 3 x upper limit of normal
- Modification of Diet in Renal Disease Study glomerular filtration rate ≥ 60 ml/min
- Signed informed consent
Exclusion
- No detectable lesions on the Ga-68 PSMA PET/CT with an uptake level below the liver uptake.
- A known subtype other than prostate adenocarcinoma
- Any medical condition present that in the opinion of the investigator will affect patients' clinical status when participating in this trial.
- Prior hip replacement surgery potentially influencing performance of PSMA PET/CT and nano Magnet Resonance Tomography (nMRI)
- Contra-indication for MRI imaging (claustrophobia, implanted electric and electronic devices (heart pacemakers, insulin pumps, implanted hearing aids, neurostimulators), intracranial metal clips, metallic bodies in the eye)
- Contra-indication for Buscopan (allergy to hyoscine or any other ingredients of this medication, allergy to to other atropines (e.g. atropine, scopolamine), myasthenia gravis, enlarged colon, glaucoma or obstructive prostatic hypertrophy)
- Additional contra-indications for the intravenous injection form of Buscopan (taking blood thinning medication (e.g. warfarin, heparin), narrowing of the gastrointestinal tract, fast heartbeat, angina or heart failure)
- Contra-indication to glucagon (pheochromocytoma)
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03828838
Start Date
July 1 2018
End Date
November 1 2019
Last Update
November 14 2019
Active Locations (1)
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1
Radiology and Nuclear Medicine
Nijmegen, Gelderland, Netherlands, 6525GA