2025-521551-23-01Not yet recruitingPhase 1/2
Sequential Chemotherapy regimen with vinorelbine and cisplatin plus PET-guided stereotactic ablative radiotherapy (SABR) for castration- and taxane-resistant Prostate cancer (ChemSABR Prostate)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 26 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 15 May 2025
- Start date
- 1 Jun 2025
- Lead sponsor
- Tartu University Hospital
- Diseases
- Prostate cancer
- EU CT number
- 2025-521551-23-01
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 80
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer that has kept growing after hormone therapy and taxane chemotherapy, with no other treatment options left.
- Age
- Men aged 40 and older.
- Sex
- Men only.
- Disease stage
- Castration-resistant and taxane-resistant prostate adenocarcinoma with confirmed progression on scan or by rising PSA. Neuroendocrine or small cell prostate cancer is excluded. ECOG performance status 0-2.
- Earlier treatment
- Must have had modern androgen deprivation therapy (for example abiraterone, enzalutamide) and taxane chemotherapy (for example docetaxel, cabazitaxel). At least 4 weeks since the last cancer treatment. All standard treatment options used up.
- Biomarker or test result
- Progression shown by CT scan or bone scan, or by PSA rising on three measurements at least one week apart, with a rise of at least 2 ng/mL.
Main reasons for not taking part
- Other illnesses that would prevent the study treatment
- Medicines that would rule out chemotherapy or radiation therapy
- Liver or kidney problems that would prevent chemotherapy
- Taking part in another clinical study
- Another cancer, except basal cell skin cancer or an earlier in situ tumour
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- The patient is not participating in another clinical study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tartu University Hospital | Tartu Linn | Estonia | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.