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Sequential Chemotherapy regimen with vinorelbine and cisplatin plus PET-guided stereotactic ablative radiotherapy (SABR) for castration- and taxane-resistant Prostate cancer (ChemSABR Prostate)
EU CTIS ID: 2025-521551-23-01
What this study is testing
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.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.