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Treatment with darolutamide +/- radiation therapy for patients with a castration resistant cancer and metastases detected by functional imaging
EU CTIS ID: 2023-507482-26-00
What this study is testing
To assess whether stereotactic radiation therapy combined with darolutamide is superior in terms of radiographic progression-free survival (rPFS) to darolutamide alone for patients with CRPC having 1 to 5 oligometastases on choline/fluciclovine or PSMA PET
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient’s consent.
- Albumin >2.5 g/dL
- Systolic blood pressure <160 mmHg and diastolic blood pressure <100 mmHg, as documented at baseline. Patients with hypertension are eligible if their hypertension is controlled and they meet all other eligibility criteria.
- Adequate kidney function with a creatinine clearance >30 mL/min (Cockcroft-Gault).
- Patient with Eastern Cooperative Oncology group (ECOG) performance status (PS) ≤1.
- Patient is willing to use contraceptive during and for at least 1 week after discontinuing darolutamide.
You likely can't join if
- Patient previously treated for metastatic castrate-resistant prostate cancer with chemotherapy or immunotherapy. Patients who received prior NHA are eligible provided: - they did not progress on previous NHA - they progressed on previous NHA and chemotherapy is not indicated by investigator
- Patients unable to comply with trial obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the trial.
- Person deprived of their liberty or under protective custody or guardianship.
- A history of cancer, other than the prostate cancer under study, within the 3 years prior to study inclusion, excluding cured localised cancer such as non-melanomatous skin cancer and non-muscle invasive bladder cancer.
- Presence of an uncontrolled disease or affection that according to the investigator will hinder compliance with the trial procedures or requires hospitalisation.
- Known to have active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease at screening
See the full eligibility criteria
Who can join
- Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient’s consent.
- Albumin >2.5 g/dL
- Systolic blood pressure <160 mmHg and diastolic blood pressure <100 mmHg, as documented at baseline. Patients with hypertension are eligible if their hypertension is controlled and they meet all other eligibility criteria.
- Adequate kidney function with a creatinine clearance >30 mL/min (Cockcroft-Gault).
- Patient with Eastern Cooperative Oncology group (ECOG) performance status (PS) ≤1.
- Patient is willing to use contraceptive during and for at least 1 week after discontinuing darolutamide.
- Patient affiliated to the social security system (or equivalent according to local regulations for participation in clinical trials).
- Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.
- Patients aged ≥18 years.
- Patient with histologically confirmed of adenocarcinoma prostate cancer without small cell or pure endocrine features.
- Patient with a history of local treatment with curative intent for localised prostate cancer, including surgery or radiotherapy.
- Patients with castration resistant prostate cancer, defined with with a combination of Castrate level of testosterone: testosterone < 50ng/dl or 1.7 nmol/L. AND at least one of the following conditions: An increasing PSA level, confirmed in 3 consecutive assessments performed at least 1 week apart despite androgen deprivation therapy; • Tumour progression of soft tissue according to the response criteria in solid tumours (RECIST) version (v)1.1; • Tumour progression on bone scan, according to PCWG3 criteria.
- Detection of 1 to 5 metastatic sites (pelvic lymph nodes included) on new generation PET using either choline, fluciclovine, or PSMA as tracer;
- All metastatic sites must be amenable to stereotactic radiation therapy.
- Patient with normal haematological function: absolute neutrophil count (ANC) >1.0 x 10^9/L, platelets count ≥100 x 10^9/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), ASAT and ALAT ≤2.5 ULN (≤5 ULN in the presence of liver metastases).
What rules you out
- Patient previously treated for metastatic castrate-resistant prostate cancer with chemotherapy or immunotherapy. Patients who received prior NHA are eligible provided: - they did not progress on previous NHA - they progressed on previous NHA and chemotherapy is not indicated by investigator
- Patients unable to comply with trial obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the trial.
- Person deprived of their liberty or under protective custody or guardianship.
- A history of cancer, other than the prostate cancer under study, within the 3 years prior to study inclusion, excluding cured localised cancer such as non-melanomatous skin cancer and non-muscle invasive bladder cancer.
- Presence of an uncontrolled disease or affection that according to the investigator will hinder compliance with the trial procedures or requires hospitalisation.
- Known to have active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease at screening
- Patients with known allergy or severe hypersensitivity to the study treatment or any of its excipients.
- Inability and/or difficulty to swallow oral medications.
- Gastrointestinal disorder or procedure that can be expected to interfere significantly with the absorption of study treatment.
- Any of the following within 6 months before randomisation: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV.
- Patients participating in another therapeutic trial within the 30 days prior to randomisation.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.