Actively Recruiting
Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging
Led by UNICANCER · Updated on 2024-12-20
336
Participants Needed
4
Research Sites
417 weeks
Total Duration
On this page
Sponsors
U
UNICANCER
Lead Sponsor
B
Bayer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed a written informed consent or had a trusted person provide consent if unable
- Male patients aged 18 years or older
- Histologically confirmed adenocarcinoma prostate cancer without small cell or pure endocrine features
- History of local treatment with curative intent such as surgery or radiotherapy
- Castration-resistant prostate cancer with increasing PSA, or tumor progression on soft tissue or bone scans
- 1 to 5 metastatic sites detected on new generation PET using choline, fluciclovine, or PSMA tracer
- All metastatic sites suitable for stereotactic radiation therapy
- Normal blood counts: neutrophils >1.0 x 10^9/L, platelets ≥100 x 10^9/L, hemoglobin ≥9.0 g/dL
- Normal liver function: bilirubin ≤1.5 times upper limit of normal unless Gilbert's syndrome, ASAT and ALAT ≤2.5 times upper limit (≤5 if liver metastases)
- Adequate liver function with bilirubin <3 mg/dL and albumin >2.5 g/dL
- Blood pressure below 160/100 mmHg; controlled hypertension allowed
- Adequate kidney function with creatinine clearance >30 mL/min
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Willing to use contraception during and at least 1 week after darolutamide
- Affiliated with social security or equivalent system
- Willing and able to comply with study protocol, treatment, and visits
You will not qualify if you...
- Prior treatment for metastatic prostate cancer with novel hormonal agents, CYP17 inhibitors, ketoconazole, chemotherapy, or immunotherapy
- History of another cancer within 3 years before study, except cured localized cancers like non-melanoma skin or non-muscle invasive bladder cancer
- Uncontrolled diseases that could interfere with study compliance or require hospitalization
- Active viral hepatitis or HIV at screening
- Known allergy or severe reaction to study treatments or their ingredients
- Unable to swallow oral medications
- Gastrointestinal disorders or procedures affecting drug absorption
- Major cardiovascular events within 6 months before randomization (stroke, heart attack, severe angina, bypass graft, or severe heart failure)
- Participation in another therapeutic trial within 30 days before randomization
- Inability to comply with study requirements due to geographic, social, or physical reasons, or lack of understanding of the trial
- Persons deprived of liberty or under protective custody or guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Groupe Hospitalier Bretagne Sud
Lorient, France, 56322
Actively Recruiting
2
Centre Azuréen de Cancérologie
Mougins, France, 06250
Actively Recruiting
3
CHU de Saint-Etienne
Saint-Etienne, France, 42055
Actively Recruiting
4
Gustave Roussy Cancer Campus
Villejuif, France, 94805
Actively Recruiting
Research Team
C
Catherine LEGER
CONTACT
M
Meryem BRIHOUM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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