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)

Phase 1

• Conditions: high-risk localized or locally advanced prostate cancer; MedDRA version: 20.0Level: PTClassification code: 10060862Term: Prostate cancer Class: 100000004864; Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]

• Registration Number: CTIS2022-500838-28-00
• Lead Sponsor: niversitaetsklinikum Essen AöR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-13
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 22

Inclusion Criteria

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 Criteria

Distant metastasis (clinical stage M1), Prior treatment with androgen receptor antagonists. Treatment with GnRH analogues prior to ICF signature, Bilateral orchiectomy, 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified