Overview
Sponsor-declared trial summary
prostate cancer
In a clinical prospective Phase I/II study, the effectiveness of vinorelbine and cisplatin, previously shown to be effective, is tested in the most effective sequence and in a clinically relevant situation (i.e., after modern androgen deprivation therapy and standard chemotherapy with taxanes, such as docetaxel and cab…
Key facts
- Sponsor
- Tartu University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Male Urogenital Diseases [C12], Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2025-06-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
In a clinical prospective Phase I/II study, the effectiveness of vinorelbine and cisplatin, previously shown to be effective, is tested in the most effective sequence and in a clinically relevant situation (i.e., after modern androgen deprivation therapy and standard chemotherapy with taxanes, such as docetaxel and cabazitaxel) in patients with castration-resistant and taxane-resistant prostate cancer who have no other treatment options available. In addition to chemotherapy, the study tests the effectiveness of PSMA-PET/CT guided stereotactic radiation therapy for oligometastatic disease in improving tumor treatment effectiveness and evaluates the safety profile of the combination.
Conditions and MedDRA coding
prostate cancer
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2025-521551-23-00 | Sequential Chemotherapy regimen with vinorelbine and cisplatin plus PET-guided stereotactic ablative radiotherapy (SABR) for castration- and taxane-resistant Prostate cancer (ChemSABR Prostate) | Tartu University Hospital |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- The study includes men aged 40 and older.
- Signed informed consent.
- Histologically confirmed prostate adenocarcinoma, excluding neuroendocrine or small cell prostate cancer.
- ECOG Performance Status 0-2.
- Diagnosis of castration- and taxane-resistant prostate cancer, with prior treatment including modern androgen deprivation therapy (e.g., abiraterone, enzalutamide) and taxane-based chemotherapy (e.g., docetaxel, cabazitaxel), resulting in disease progression.
- Confirmed disease progression, defined as: Radiological progression on CT scan or bone scintigraphy, or PSA progression, characterized by an increase in PSA levels on three consecutive measurements taken at least one week apart, with a minimum increase of 2 ng/mL.
- At least 4 weeks elapsed since completion of prior cancer therapy.
- Exhaustion of all standard treatment options, as determined by a multidisciplinary oncological consensus, with no further therapeutic alternatives available.
Exclusion criteria 5
- The patient does not have any concomitant diseases or conditions that would prevent the administration of study treatment.
- The patient is not taking medications that would contraindicate chemotherapy and/or radiation therapy.
- The patient does not have liver or kidney dysfunctions that would prevent chemotherapy administration.
- The patient is not participating in another clinical study.
- The patient does not have any other malignancies, except for basal cell skin cancer or a previous in situ tumor.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Safety is the primary outcome measure in Phase I of this study, PFS is the primary outcome measure in Phase II.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB00069MIG · Substance
- Active substance
- Vinorelbine
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07483MIG · Substance
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- 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
Tartu University Hospital
- Sponsor organisation
- Tartu University Hospital
- Address
- L. Puusepa Tn 1a
- City
- Tartu Linn
- Postcode
- 50406
- Country
- Estonia
Scientific contact point
- Organisation
- Tartu University Hospital
- Contact name
- Marju Kase
Public contact point
- Organisation
- Tartu University Hospital
- Contact name
- Marju Kase
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Estonia | Authorised, recruitment pending | 80 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol EU CT 2025-521551-23-00 | 1 |
| Recruitment arrangements (for publication) | NA | 1 |
| Subject information and informed consent form (for publication) | L1_ICF in Estonian_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF in Russian_redacted | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Cisplatin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Vinorelbin | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-15 | Estonia | Acceptable 2025-06-26
|
2025-06-26 |