RecruitingPhase 3NCT06276465

Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging

Combination of Darolutamide and Stereotactic Body Radiation Therapy in Patients With Castration Resistant Prostate Cancer and Oligometastases on Functional Imaging


Sponsor

UNICANCER

Enrollment

336 participants

Start Date

Oct 7, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment strategy for men with castration-resistant prostate cancer (cancer that keeps growing despite hormone therapy) who have a small number of metastases detected on advanced PET scans. It evaluates whether adding targeted radiation to those metastases on top of a hormone-blocking drug (darolutamide) improves outcomes. **You may be eligible if...** - You are 18 years or older with confirmed prostate cancer - Your cancer has been previously treated (surgery or radiation) but has come back and is now resistant to standard hormone therapy - You have 1 to 5 metastatic spots visible on a new-generation PET scan - All metastatic sites can be safely treated with focused (stereotactic) radiation - Your blood counts are within acceptable ranges **You may NOT be eligible if...** - You have more than 5 metastatic sites - Your metastases cannot be safely radiated - You have certain prior treatments that disqualify you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDarolutamide 300 mg

2 tablets of 300 mg twice daily (=1200 mg/day) up to 5 years from randomisation

RADIATIONStereotactic body radiation therapy

Over one week,30 Gy in 3 fractions of 10 Gy

DRUGAndrogen deprivation therapy

Continuous ADT during the study course. The choice of ADT is left to the discretion of the investigator.


Locations(4)

Groupe Hospitalier Bretagne Sud

Lorient, France

Centre Azuréen de Cancérologie

Mougins, France

CHU de Saint-Etienne

Saint-Etienne, France

Gustave Roussy Cancer Campus

Villejuif, France

View Full Details on ClinicalTrials.gov

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NCT06276465


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