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Study identifier: NCT06276465 Synced from ClinicalTrials.gov · July 28, 2026
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Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging

Condition: Prostatic Cancer, Castration-Resistant  ·  Sponsor: UNICANCER

PhasePhase 3
Planned participants336
Who can joinMale, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 darolut…

This description comes directly from the study's public registry record.

Talk to the study team

Catherine LEGER  ·  0033 7 79 83 23 98  ·  c-leger@unicancer.fr

Meryem BRIHOUM  ·  0033 1 80 50 12 95  ·  m-brihoum@unicancer.fr

Always discuss trial participation with your own doctor first.

Locations (4)

Groupe Hospitalier Bretagne SudLorient, FranceRecruiting
Centre Azuréen de CancérologieMougins, FranceRecruiting
CHU de Saint-EtienneSaint-Etienne, FranceRecruiting
Gustave Roussy Cancer CampusVillejuif, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT06276465