Overview
Sponsor-declared trial summary
high-risk localized or locally advanced prostate cancer
- 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 …
Key facts
- Sponsor
- Universitaetsklinikum Essen AöR
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Male Urogenital Diseases [C12]
- Trial duration
- 10 Sep 2024 → ongoing
- Decision date (initial)
- 2023-11-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Advanced Accelerator Applications International S.A.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Dose response, Therapy
- 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
Secondary objectives 1
- Efficacy of intra-arterial [177Lu]Lu-PSMA-617 in the neoadjuvant treatment of patients with high-risk, localised or locally advanced prostate cancer
Conditions and MedDRA coding
high-risk localized or locally advanced prostate cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10060862 | Prostate cancer | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- 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 6
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Adverse Events related to intra-arterial [177Lu]Lu-PSMA-617 therapy
- Days of delay of scheduled surgery due to AEs related to intra-arterial [177Lu]Lu-PSMA-617 therapy
Secondary endpoints 2
- PSA-response
- Pathological response as measured by pathological complete response (pCR) and minimal residual disease (MRD), defined as a tumour burden of 5 mm or less in greatest dimensions.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Pluvicto 1 000 MBq/mL solution for injection/infusion
PRD10117050 · Product
- Active substance
- Lutetium (177LU) Vipivotide Tetraxetan
- Substance synonyms
- Lutetium Lu 177 vipivotide tetraxetan, 177LU-PSMA-617, VIPIVOTIDE TETRAXETAN LUTETIUM LU-177, LUTETIUM (177LU) PROSTATE-SPECIFIC MEMBRANE ANTIGEN, PSMA-617 LU-177
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAARTERIAL USE
- Authorisation status
- Authorised
- ATC code
- V10XX — VARIOUS THERAPEUTIC RADIOPHARMACEUTICALS
- Marketing authorisation
- EU/1/22/1703/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaetsklinikum Essen AöR
- Sponsor organisation
- Universitaetsklinikum Essen AöR
- Address
- Hufelandstrasse 55, Holsterhausen Holsterhausen
- City
- Essen
- Postcode
- 45147
- Country
- Germany
Scientific contact point
- Organisation
- Universitaetsklinikum Essen AöR
- Contact name
- Principle Investigator/legal representative
Public contact point
- Organisation
- Universitaetsklinikum Essen AöR
- Contact name
- Principle Investigator/legal representative
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| ABX CRO advanced pharmaceutical services Forschungsgesellschaft mbH ORG-100026303
|
Dresden, Germany | On site monitoring, Code 10, Code 11, Code 12, Code 5, Data management, E-data capture, Code 8 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 22 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2024-09-10 | 2024-10-08 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 14 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol appendix EPIC-26_GER | 1 |
| Protocol (for publication) | D1_ Protocol appendix EQ-5D-5L_GER | 1 |
| Protocol (for publication) | D1_ Protocol appendix FACT-RNT_GER | 1 |
| Protocol (for publication) | D1_ Protocol appendix PRO-CTCAE_GER | 1 |
| Protocol (for publication) | D1_ Protocol_2022-500838-28-00_redacted | 3.0 |
| Protocol (for publication) | D1_ Protocol_2022-500838-28-00_TC | 3.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adult patients_GER_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adult patients_GER_TC_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material add statement of patient questionnaires | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Patient Card_GER | 2.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Patient Card_GER_TC | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ add statement to SmPC | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ENG_2022-500838-28-00 | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-13 | Germany | Acceptable 2023-11-24
|
2023-11-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-20 | Germany | Acceptable 2024-07-12
|
2024-07-17 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-29 | Germany | Acceptable 2024-07-12
|
2024-08-29 |
| 4 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-04-02 | Germany | Acceptable 2026-04-23
|
2026-04-27 |