CISPLATIN for Prostate cancer|Castration-resistant prostate cancer|Taxane-resistant prostate cancer

Inclusion criteria

• {"criterion_text":"- The study includes men aged 40 and older.\n- Signed informed consent.\n- Histologically confirmed prostate adenocarcinoma, excluding neuroendocrine or small cell prostate cancer.\n- ECOG Performance Status 0-2.\n- 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.\n- 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.\n- At least 4 weeks elapsed since completion of prior cancer therapy.\n- Exhaustion of all standard treatment options, as determined by a multidisciplinary oncological consensus, with no further therapeutic alternatives available."}

Exclusion criteria

• {"criterion_text":"- The patient does not have any concomitant diseases or conditions that would prevent the administration of study treatment.\n- The patient is not taking medications that would contraindicate chemotherapy and/or radiation therapy.\n- The patient does not have liver or kidney dysfunctions that would prevent chemotherapy administration.\n- The patient is not participating in another clinical study.\n- The patient does not have any other malignancies, except for basal cell skin cancer or a previous in situ tumor."}

Primary endpoints

• {"endpoint_text":"- Safety is the primary outcome measure in Phase I of this study, PFS is the primary outcome measure in Phase II.","definition_or_measurement_approach":""}

Estonia

Earliest CTIS Part Ii Submission Date

08-06-2025

Latest Decision Or Authorization Date

26-06-2025

Processing Time Days

18

Number Of Sites

1

Number Of Participants

80

Primary sponsor

Full Name

Tartu University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Estonia