OncoMatch/Clinical Trials/NCT06276465
Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging
Is NCT06276465 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Darolutamide 300 mg and Androgen deprivation therapy for prostatic cancer, castration-resistant.
Treatment: Darolutamide 300 mg · Androgen deprivation therapy — In earlier stages of prostate cancer, male sexual hormones (androgens) stimulate the growth of cancer cells. Castration-resistant prostate cancer (CRPC) means that the prostate cancer continued to grow despite patients are taking hormone therapy to control the disease. One of the standard treatments for these patients is so-called 'new generation' hormonal therapy. These hormone therapies include apalutamide, enzalutamide, or darolutamide. They work by blocking androgen receptors that play an important role in the growth of prostate cancer. In the case of oligometastatic CRPC, the cancer has gone beyond the prostate and has spread to other organs in the body (metastases), but these metastases remain limited in number. An early detection of the oligometastatic CRPC and appropriate treatment may prolong survival in these patients. The treatment proposed as part of this research is a combination of oral darolutamide, approved in Europe to treat patients with CRPC who do not have metastasis visible on CT-scan or bone scintigraphy (but visible with positron emission tomography-scan (PET-Scan), a more precise imaging technique) with stereotactic body radiotherapy (SBRT), a new radiotherapy technique guided by very high precision medical imaging. This method makes it possible to better target cancer cells while preserving neighboring healthy organs. The principal objective of this trial is to evaluate the efficacy of the combination of SBRT with darolutamide, compared to darolutamide.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: local treatment with curative intent (surgery, radiotherapy) — localized prostate cancer
history of local treatment with curative intent for localised prostate cancer, including surgery or radiotherapy
Cannot have received: novel hormonal agent
previously treated for metastatic prostate cancer with a novel hormonal agent (NHA)
Cannot have received: CYP17 inhibitor
previously treated for metastatic prostate cancer with a CYP17 inhibitor
Cannot have received: ketoconazole (ketoconazole)
previously treated for metastatic prostate cancer with...ketoconazole
Cannot have received: chemotherapy
previously treated for metastatic prostate cancer with...chemotherapy
Cannot have received: immunotherapy
previously treated for metastatic prostate cancer with...immunotherapy
Lab requirements
Blood counts
ANC >1.0 x 10⁹/L, platelets ≥100 x 10⁹/L, haemoglobin ≥9.0 g/dL
Kidney function
creatinine clearance >30 mL/min (Cockcroft-Gault)
Liver function
total bilirubin ≤1.5 ULN (unless documented Gilbert's syndrome), ASAT and ALAT ≤2.5 ULN (≤5 ULN in the presence of liver metastases); bilirubin <3 mg/dL and albumin >2.5 g/dL
Cardiac function
systolic blood pressure <160 mmHg and diastolic blood pressure <100 mmHg; no stroke, MI, severe/unstable angina, coronary/peripheral artery bypass graft, or NYHA Class III/IV CHF within 6 months
Patient with normal haematological function: absolute neutrophil count (ANC) >1.0 x 10⁹/L, platelets count ≥100 x 10⁹/L, and haemoglobin ≥9.0 g/dL. Patient with normal liver function with total bilirubin ≤1.5 upper limit of normal (ULN) (unless documented Gilbert's syndrome), aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤2.5 ULN (≤5 ULN in the presence of liver metastases). Adequate liver function with bilirubin <3 mg/dL and albumin >2.5 g/dL. Systolic blood pressure <160 mmHg and diastolic blood pressure <100 mmHg. Adequate kidney function with a creatinine clearance >30 mL/min (Cockcroft-Gault).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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