Overview
Sponsor-declared trial summary
Prostate Carcinoma
To evaluate the PSA, imaging and pathological response, as well as oncological outcomes of systemic PSMA-RLT in patients planned for radical prostatectomy (RP) for oligometastatic prostate cancer (PCa) diagnosed using [68Ga]Ga-PSMA-11 PET
Key facts
- Sponsor
- Medical University Of Vienna
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 14 Jan 2025 → ongoing
- Decision date (initial)
- 2025-01-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519377-18-00
- EudraCT number
- 2022-004115-92
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Efficacy
To evaluate the PSA, imaging and pathological response, as well as oncological outcomes of systemic PSMA-RLT in patients planned for radical prostatectomy (RP) for oligometastatic prostate cancer (PCa) diagnosed using [68Ga]Ga-PSMA-11 PET
Conditions and MedDRA coding
Prostate Carcinoma
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- • Patients must be adults between 18 and 75 years of age. • Oligometastatic PCa diagnosed using [68Ga]Ga-PSMA-11 imaging defined as M1a and/or M1b positive with ≤5 osseous metastases and/or M1c ≤3 lung metastases • Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1 • Patients must have adequate bone marrow reserve: WBC ≥1.5 x 109 /L, Platelets ≥100 x 109 /L and Haemoglobin ≥9 g/dL. • Patients must have adequate renal function with eGFR ≥ 50mL/min/1.73m2 using the Modification of Diet Renal Disease (MDRD) equation and an Albumin level of ≥2.5 g/dL. • Patients must be able to sign Informed Consent Form
Exclusion criteria 1
- • Patients must be adults between 18 and 80 years of age. • Patients with BCR after RP and RT with a PSA doubling-time (DT) of ≤ 12 months. • No hormonal therapy within the last 12 months or recovered testosterone levels. • PSMA PET negative result for local recurrence; presence of distant metastases is allowed: (cN0, cM0/cM1). • Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1 • Patients must have adequate bone marrow reserve: WBC ≥1.5 x 109 /L, Platelets ≥100 x 109 /L and Haemoglobin ≥9 g/dL. • Patients must have adequate renal function with eGFR ≥ 50mL/min/1.73m2 using the Modification of Diet Renal Disease (MDRD) equation and an Albumin level of ≥2.5 g/dL. • Patients must be able to sign Informed Consent Form.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- • Assess safety and toxicity of neoadjuvant PSMA-RLT and RP
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Lutetium (177LU) Zadavotide Guraxetan
PRD11715109 · Product
- Active substance
- Lutetium (177LU) Zadavotide Guraxetan
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 5.5 GBq gigabecquerel(s)
- Max total dose
- 11 GBq gigabecquerel(s)
- Max treatment duration
- 200 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- MEDICAL UNIVERSITY OF VIENNA
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 2
PRD889848 · Product
- Active substance
- Stannous Oxide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 700 MBq megabecquerel(s)
- Max total dose
- 10000 MBq megabecquerel(s)
- Max treatment duration
- 500 Month(s)
- Authorisation status
- Authorised
- ATC code
- V09BA04 — TECHNETIUM (99MTC) BUTEDRONIC ACID
- Marketing authorisation
- 4-00026
- MA holder
- CIS BIO INTERNATIONAL
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Locametz 25 micrograms kit for radiopharmaceutical preparation
PRD10117086 · Product
- Active substance
- Gozetotide
- Substance synonyms
- AAA517, OH-Glu-CO-Lys(Ahx-CC-HBED)-OH
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 259 MBq megabecquerel(s)
- Max total dose
- 10000 MBq megabecquerel(s)
- Max treatment duration
- 200 Month(s)
- Authorisation status
- Authorised
- ATC code
- V09IX14 — -
- Marketing authorisation
- EU/1/22/1692/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medical University Of Vienna
- Sponsor organisation
- Medical University Of Vienna
- Address
- Spitalgasse 23, Alsergrund Alsergrund
- City
- Vienna
- Postcode
- 1090
- Country
- Austria
Scientific contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Department of Biomedical Imaging and Image-guided Therapy, Division of Nuclear Medicine
Public contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Department of Biomedical Imaging and Image-guided Therapy, Division of Nuclear Medicine
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 10 | 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 |
|---|---|---|---|---|---|
| Austria | 2025-01-14 | 2025-01-14 |
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_redacted_clean_Protocol 2024-519377-18-00 | 1.3 |
| Protocol (for publication) | redacted Medical University of Vienna_Clinical_Trial_NEO_PSMA_RLT_V1_2 | 1.3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | Medical University of Vienna NEO psma rlt v1 1 | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | Medical University of Vienna Empty Placeholder | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis AT 2024 519377 18 00 | 1 |
| Synopsis of the protocol (for publication) | EORTC_QLQC30 | 3 |
| Synopsis of the protocol (for publication) | FACT-P_GER_Final_Ver4 | 4 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-07 | Austria | Acceptable 2025-01-10
|
2025-01-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-24 | Austria | Acceptable 2025-05-30
|
2025-06-02 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-30 | Austria | Acceptable 2025-11-16
|
2025-11-17 |