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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)
EU CTIS ID: 2022-500838-28-00
What this study is testing
- 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
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.