Sequential Chemotherapy regimen with vinorelbine and cisplatin plus PET-guided stereotactic ablative radiotherapy (SABR) for castration- and taxane-resistant Prostate cancer (ChemSABR Prostate)
Key facts
- Where
- Tartu Linn, ÉsztországSee the site
- Phase
- 1/2. fázis
Where in Észtország
- Tartu University HospitalTartu Linn, ÉsztországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tartu University Hospital
- Trial code
- EU 2025-521551-23-01
- Record updated
- 2025. június 26.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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 does not have any other malignancies, except for basal cell skin cancer or a previous in situ tumor; The patient is not participating in another clinical study.