2022-500838-28-00RecruitingPhase 1/2
A Phase I/II Study of Neoadjuvant, Intra-arterial Administration of [177Lu]Lu-PSMA-617 in Subjects with High-risk, Localised or Locally Advanced Prostate Cancer who are Candidates for Radical Prostatectomy (LUPUS)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 1 Jul 2026
Brief summary (registry, in English)
- Safety and tolerability of intra-arterial [177Lu]Lu-PSMA-617 in the neoadjuvant treatment of patients with high-risk, localised or locally advanced prostate cancer scheduled for radical prostatectomy - Feasibility of intra-arterial [177Lu]Lu-PSMA-617 for neoadjuvant treatment of patients with high-risk, localised or locally advanced prostate cancer scheduled for radical prostatectomy
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 22 (estimated)
- First submitted
- 13 Sept 2023
- Start date
- 10 Sept 2024
- Lead sponsor
- Universitaetsklinikum Essen AöR
- Diseases
- Prostate cancer
- EU CT number
- 2022-500838-28-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 22
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with high-risk prostate cancer that is still in the prostate area, who have not been treated yet and are planned for prostate removal surgery.
- Age
- 18 years or older.
- Sex
- Men only.
- Disease stage
- High-risk localised or locally advanced prostate cancer (adenocarcinoma) with no distant spread (no M1), and PSMA-positive disease on a PSMA-PET scan.
- Earlier treatment
- No earlier treatment for prostate cancer. GnRH analogue treatment before signing the consent form is allowed. No radioligand treatment in the last 6 months.
- Biomarker or test result
- PSMA-positive disease seen on a PSMA-PET scan.
Main reasons for not taking part
- Distant metastasis (clinical stage M1)
- Earlier treatment with androgen receptor antagonists
- Earlier systemic or local therapy for prostate cancer, including pelvic radiation
- Both testicles removed (bilateral orchiectomy)
- Major surgery within 4 weeks before joining
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with androgen receptor antagonists. Treatment with GnRH analogues prior to ICF signature
- History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer
- Major surgery ≤4 weeks prior to inclusion
- Previous treatment with radioligands within 6 months before inclusion
Other
- Distant metastasis (clinical stage M1)
- Bilateral orchiectomy
Who the study is looking for
- Histologically confirmed adenocarcinoma of the prostate including the following criteria: - High-risk prostate cancer defined by: a) a total Gleason sum score ≥4+4 (=ISUP Grade Groups 4 5), or b) any Gleason sum score and serum PSA-level ≥ 20 ng/mL or - Locally advanced high-risk prostate cancer (≥pT3a) defined as a) Extracapsular extension confirmed by mpMRI or PSMA-PET scan and/or b) Positive pelvic lymph nodes on pre-study PSMA-PET scan or c) Suspicion of pelvic lymph node involvement (cN1) on conventional imaging
- Treatment-naïve patients for adenocarcinoma of the prostate
- Eastern Cooperative Oncology Group (ECOG) performance status 0 1
- Candidate eligible for intra-arterial treatment as per investigator
- Candidate scheduled for radical prostatectomy with pelvic lymph node dissection as per the investigator
- Adequate bone marrow function, liver and renal function
- Patients must be willing to use a condom for all sexual activities
- Patients must have evidence of PSMA-positive disease as seen on a PSMA-PET scan
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaetsklinikum Essen (AoR) | Essen | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.