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)
Key facts
- Where
- Essen, NémetországSee the site
- Phase
- 1/2. fázis
Where in Németország
- Universitaetsklinikum Essen (AoR)Essen, NémetországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitaetsklinikum Essen AöR
- Trial code
- EU 2022-500838-28-00
- Record updated
- 2026. július 1.
- Original description
- 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 prostatectomyRead full original descriptionShow less
- 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
Inclusion: 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.
Exclusion: 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.