Clinical trial · Interventional
Lutetium-177-PSMA-617 in Low Volume Metastatic Prostate Cancer
Pilot Study: Lutetium-177-PSMA-617 in Low Volume Metastatic Prostate Cancer
NCT03828838CI-TRIAL-00041625completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Neoplasm | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lu-177 PSMA-617 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lu-177 PSMA-617
- description
- Two cycles with 3 and 3-6 GBq Lu-177 PSMA-617 (including 3D-dosimetry)
- interventionNames
- Drug: Lu-177 PSMA-617
Primary outcomes (4)
- measure
- Doses delivered to the tumors
- timeFrame
- For cycle 1 (duration of one cycle is 56 days)
- description
- Calculation of the doses given in Gray per gigabequerel (Gy/GBq) delivered to the tumors
- measure
- Doses delivered to the tumors
- timeFrame
- For cycle 2 (duration of one cycle is 56 days)
- description
- Calculation of the doses given in Gray per gigabequerel (Gy/GBq) delivered to the tumors
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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)
References
Publications (2)
- DERIVEDPeters SMB, Mink MCT, Prive BM, de Bakker M, de Lange F, Muselaers CHJ, Mehra N, Witjes JA, Gotthardt M, Nagarajah J, Konijnenberg MW. Optimization of the radiation dosimetry protocol in Lutetium-177-PSMA therapy: toward clinical implementation. EJNMMI Res. 2023 Jan 24;13(1):6. doi: 10.1186/s13550-023-00952-z. PMID 36692682
- DERIVEDPrive BM, Peters SMB, Muselaers CHJ, van Oort IM, Janssen MJR, Sedelaar JPM, Konijnenberg MW, Zamecnik P, Uijen MJM, Schilham MGM, Eek A, Scheenen TWJ, Verzijlbergen JF, Gerritsen WR, Mehra N, Kerkmeijer LGW, Smeenk RJ, Somford DM, van Basten JA, Heskamp S, Barentsz JO, Gotthardt M, Witjes JA, Nagarajah J. Lutetium-177-PSMA-617 in Low-Volume Hormone-Sensitive Metastatic Prostate Cancer: A Prospective Pilot Study. Clin Cancer Res. 2021 Jul 1;27(13):3595-3601. doi: 10.1158/1078-0432.CCR-20-4298. Epub 2021 Apr 21. PMID 33883176