NCT04443062CompletedPhase 2
Lutetium-177-PSMA-617 in Oligo-metastatic Hormone Sensitive Prostate Cancer
Lutetium-177-PSMA-617 Radioligand Therapy in Oligo-metastatic Hormone Sensitive Prostate Cancer.
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
Radioligand therapy (RLT) using Lutetium-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 patients. To date, there are no prospective randomized studies published using this treatment in the hormone sensitive setting or in oligometastatic prostate cancer. Therefore, this study we will evaluate the effect of 177Lu-PSMA in patients with hormone sensitive oligo-metastatic prostate cancer.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 58 (actual)
- First submitted
- 17 Jun 2020
- Start date
- 20 Jul 2020
- Primary completion date
- 1 Apr 2025
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Prostate cancer
- NCT number
- NCT04443062
- EU CT number
- 2023-509881-39-00
- EudraCT number
- 2020-000076-37
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 58
- From 20 Jul 2020 to the primary completion date, 1 Apr 2025
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous PSMA based radioligand treatment.
- Prior hip replacement surgery potentially influencing performance of PSMA PET/CT.
Other illness
- Any medical condition present that in the opinion of the investigator will affect patients' clinical status when participating in this trial.
- Sjogren's syndrome
- A second active malignancy other than prostate cancer.
Other
- A known subtype other than prostate adenocarcinoma.
- Visceral or brain metastases.
- Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception.
Who the study is looking for
- Histological proven adenocarcinoma of the prostate with sufficient archived tumor material. This material has to be archived till study closure.
- Biochemical recurrence (PSA \> 1.0 µg/l).
- PSA-doubling time \< 6 months. Serum PSA progression is defined as 2 consecutive rising PSA values measured at least 1 week apart. The minimal start value is 0.2 µg/l.
- 18F-PSMA-PET-CT positive metastases in bones and/or lymph nodes (N1/M1ab): ≥1, maximally 5 metastases.
- 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 or if the patient refuse these treatments).
- No prior hormonal therapy (including any androgen directed treatment such as finasteride, dutasteride, bicalutamide, apalutamide, abiraterone or enzalutamide) or taxane based chemotherapy (docetaxel or cabazitaxel); testosterone \> 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 6 months.
- A detectable lesion on the 18F-PSMA PET/CT with significant PSMA avidity, defined by a SUVmax \> 15 (partial volume corrected).
- ECOG 0-1
- Patients must have a life expectancy \>6 months.
- Laboratory values:
- White blood cells \> 3.0 x 109/l
- Platelet count \> 75 x 109/l
- Hemoglobin \> 6.2 mmol/l
- ASAT, ALAT \< 3 x ULN
- MDRD-GFR ≥ 50 ml/min
- Signed informed consent.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Linac-Pet Scan Opco Limited Coordinator of this site? Confirm its status | Limassol | Cyprus | Completed |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Completed |
| Radboud Universitair Medisch Centrum (Radboudumc) Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Completed |
Related publications
- [177Lu]-PSMA-617-PSMA-617 in oligometastatic hormone sensitive prostate cancer (BULLSEYE): an open-label, randomised, phase 2 study.Lancet Oncol · 2026 · PMID 41926960
This page is information, not medical advice. Discuss any trial with your doctor.