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Not yet taking people in EstoniaPhase 1/2

Tests chemotherapy with targeted radiation in men with resistant prostate cancer

Tests vinorelbine and cisplatin with scan-guided radiation in adults with advanced, treatment-resistant prostate cancer.

Key facts

Who runs it
Tartu University Hospital
Where
Tartu Linn, EstoniaSee the site
Registry title
Sequential Chemotherapy regimen with vinorelbine and cisplatin plus PET-guided stereotactic ablative radiotherapy (SABR) for castration- and taxane-resistant Prostate cancer (ChemSABR Prostate)
Status
Not yet recruiting
Phase
Phase 1/2
People taking part
80 people, planned
Started
1 Jun 2025
Expected to end
31 Dec 2026
Type of study
Interventional
Record updated
26 June 2025

Who can take part

AI summary

From the trial's eligibility criteria. 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

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Estonia

  • Tartu University HospitalTartu Linn, EstoniaNot yet recruiting

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Sequential Chemotherapy regimen with vinorelbine and cisplatin plus PET-guided stereotactic ablative radiotherapy (SABR) for castration- and taxane-resistant Prostate cancer (ChemSABR Prostate)
Plain-language title
Tests chemotherapy with targeted radiation in men with resistant prostate cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
26 June 2025