TheranosticTrials.org

Clinical Trial · NCT03828838

Lutetium-177-PSMA-617 in Low Volume Metastatic Prostate Cancer

Overview

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 membrane antigen (PSMA), which is overexpressed in prostate cancer cells. In the last few years, several lutetium-177 (177Lu, β emitter) labeled PSMA ligands have been developed and are currently applied to treat metastatic castrate resistant prostate cancer (mCRPC) patients. However, there are no prospective studies published so far using this treatment approach in hormone sensitive setting. In this pilot study patients with hormone sensitive prostate cancer who did not undergo hormonal treatment will be treated with Lu-177 PSMA-617.

Sponsor

Radboud University Medical Center

Phase

Phase 1/2

Contacts

James Nagarajah, Prof. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03828838

Drug / Compound

PSMA-617

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • 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)
  • Prior local therapy for prostate cancer
  • No visceral metastases
  • Modification of Diet in Renal Disease Study glomerular filtration rate ≥ 60 ml/min
  • White blood cells \> 3.5 x 109/l
  • 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
  • Histological proven adenocarcinoma of the prostate
  • Laboratory values:
  • PSA-DT \< 6 months
  • Platelet count \> 150 x 109/l
  • Alanine transaminase, aspartate aminotransferase \< 3 x upper limit of normal
  • Biochemical recurrence or clinical progression after local therapy (PSA \> 0.2 µg/l),
  • Hemoglobin \> 6 mmol/l

Exclusion

  • Any medical condition present that in the opinion of the investigator will affect patients' clinical status when participating in this trial.
  • A known subtype other than prostate adenocarcinoma
  • 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)
  • No detectable lesions on the Ga-68 PSMA PET/CT with an uptake level below the liver uptake.
  • 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)
  • Prior hip replacement surgery potentially influencing performance of PSMA PET/CT and nano Magnet Resonance Tomography (nMRI)
  • 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)