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Taking people in GermanyPhase 1/2

Tests an intra-arterial radioactive drug before surgery for high-risk prostate cancer

Tests a radioactive drug given into an artery before surgery in men with prostate cancer.

Key facts

Who runs it
Universitaetsklinikum Essen AöR
Where
Essen, GermanySee the site
Registry title
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)
Status
Recruiting
Phase
Phase 1/2
People taking part
22 people, planned
Started
10 Sept 2024
Expected to end
30 Sept 2027
Type of study
Interventional
Record updated
1 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. 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

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Distant metastasis (clinical stage M1)
  • Bilateral orchiectomy

Where in Germany

  • Universitaetsklinikum Essen (AoR)Essen, GermanyTaking people

About the trial

What the trial wants to find out

- 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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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)
Plain-language title
Tests an intra-arterial radioactive drug before surgery for high-risk prostate cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
1 July 2026