Overview
Sponsor-declared trial summary
Prostate Cancer
To determine if the use of Prostate-Specific Membrane Antigen Positron Emission Computer Tomography (PSMA PET/CT) as a selection tool for performing extended pelvic lymph node dissection (ePLND) for prostate cancer (PCa) in the primary staging setting results in fewer ePLND procedures and therefore lower overall health…
Key facts
- Sponsor
- Canisius Wilhelmina Ziekenhuis
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Male Urogenital Diseases [C12]
- Trial duration
- 23 Jan 2025 → ongoing
- Decision date (initial)
- 2025-01-23
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518171-59-00
- EudraCT number
- 2021-002055-12
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
To determine if the use of Prostate-Specific Membrane Antigen Positron Emission Computer Tomography (PSMA PET/CT) as a selection tool for performing extended pelvic lymph node dissection (ePLND) for prostate cancer (PCa) in the primary staging setting results in fewer ePLND procedures and therefore lower overall healthcare costs, lower patient burden in terms of intervention-related complications and morbidity, with comparable (non-inferior) disease prognosis, compared to the current European Guideline-recommended standard practice which includes performing ePLND in PCa patients who are candidates for active treatment with a nomogram-calculated lymph node involvement (LNI) risk >5%.
Secondary objectives 1
- If use of PSMA PET/CT as a selection tool for ePLND in the primary PCa staging setting results in fewer ePLND procedures and therefore lower overall healthcare costs and less patient burden in terms of intervention-related complications and morbidity compared to the current standard practice.
Conditions and MedDRA coding
Prostate Cancer
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | PSMA-SELECT study Study design: Randomized controlled trial
Study population: Patients with newly-diagnosed PCa, without evidence of distant metastasis (any T, M0), who are candidates for treatment with radical prostatectomy and ePLND based on a nomogram-calculated risk of LNI >5%.
Intervention: The PSMA selected ePLND (intervention) is compared to the nomogram-based ePLND which is the standard of care according to the guideline on PCa of the European Urologic Association (EAU).
|
Randomised Controlled | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Age ≥18 years 2. Biopsy proven adenocarcinoma of the prostate 3. Indication for ePLND combined with RARP 4. Suitable for robot-assisted ePLND + RARP 5.. Mentally competent and understanding of benefits and potential burden of the study 6. Written informed consent
Exclusion criteria 1
- A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. History of prior diagnosed or treated PCa 2. Known concomitant malignancies (except Basal Cell Carcinoma of the skin) 3.Unwillingness or inability to undergo PSMA PET/CT and/or ePLND 4. PSMA non-avid PCa (local tumor activity) 5. Presence of distant metastasis (M1)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Biochemical recurrence rate within two years after surgery, defined as a PSA > 0.2 ng/ml.
Secondary endpoints 1
- - Total number of ePLNDs and PSMA PET/CTs performed and their intervention-related healthcare costs, costs of complication-related interventions and associated (prolonged) hospital stay. - Biochemical persistence, defined as PSA >0.1 within half a year after surgery - Surgical complications within 6 months after surgery. - Total nodes resected on ePLND and number of positive and negative nodes within and outside of the standard ePLND template. The necessity for a second PSMA PET / CT.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
Locametz 25 micrograms kit for radiopharmaceutical preparation
PRD10117083 · Product
- Active substance
- Gozetotide
- Substance synonyms
- AAA517, OH-Glu-CO-Lys(Ahx-CC-HBED)-OH
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 360 MBq megabecquerel(s)
- Max total dose
- 360 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX14 — -
- Marketing authorisation
- EU/1/22/1692/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB208557 · Substance
- Active substance
- 18F-PSMA-1007
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 400 MBq megabecquerel(s)
- Max total dose
- 400 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB189818 · Substance
- Active substance
- Piflufolastat (18F)
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Max daily dose
- 360 MBq megabecquerel(s)
- Max total dose
- 360 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Canisius Wilhelmina Ziekenhuis
- Sponsor organisation
- Canisius Wilhelmina Ziekenhuis
- Address
- Weg Door Jonkerbos 100
- City
- Nijmegen
- Postcode
- 6532 SZ
- Country
- Netherlands
Scientific contact point
- Organisation
- Canisius Wilhelmina Ziekenhuis
- Contact name
- Liselot Ribbert
Public contact point
- Organisation
- Canisius Wilhelmina Ziekenhuis
- Contact name
- Liselot Ribbert
Locations
1 EU/EEA country · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruitment ended | 742 | 17 |
| 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 |
|---|---|---|---|---|---|
| Netherlands | 2025-01-23 | 2025-01-23 | 2025-10-09 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-518171-59-00_redacted | 7.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements V2 15DEC2024 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_redacted | 3.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC 18F-DCFPyL | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC 18F-PSMA-1007 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ga68-PSMA | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG 2024-518171-59-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL 2024-518171-59-00 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-23 | Netherlands | Acceptable with conditions 2025-01-23
|
2025-01-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-25 | Netherlands | Acceptable 2025-07-31
|
2025-07-31 |