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New treatment option for Prostatic Cancer, Castration-Resistant
Official title Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging
ClinicalTrials.gov ID: NCT06276465
What this study is testing
What is Darolutamide 300 mg?
Darolutamide 300 mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for prostatic cancer, castration-resistant.
Also referred to as Nubeqa.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
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...
- 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 as either:
You likely can't join if
- Patient previously treated for metastatic prostate cancer with a novel hormonal agent (NHA), a CYP17 inhibitor, ketoconazole, chemotherapy, or...
- A history of cancer, other than the prostate cancer under study, within the 3 years prior to study inclusion, excluding cured localised cancer such...
- Presence of an uncontrolled disease or affection that according to the investigator will hinder compliance with the trial procedures or requires...
- Known to have active viral hepatitis, active human immunodeficiency virus (HIV) A at screening.
- Patients with known allergy or severe hypersensitivity to the study treatment or any of its excipients.
- Inability to swallow oral medications.
See the full eligibility criteria
- 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...
- 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 as either:
- An increasing PSA level, confirmed in 3 consecutive assessments performed at least 1 week apart. This despite androgen deprivation therapy and castrate levels of testosterone.
- 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. N.B. The two latter conditions only apply to the M1CRPC population.
- 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 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...
- Adequate liver function with bilirubin \ 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...
- 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.
- Patient previously treated for metastatic prostate cancer with a novel hormonal agent (NHA), a CYP17 inhibitor, ketoconazole, chemotherapy, or immunotherapy.
- 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) A at screening.
- Patients with known allergy or severe hypersensitivity to the study treatment or any of its excipients.
- Inability 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...
- Patients participating in another therapeutic trial within the 30 days prior to randomisation.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Lorient, France
- Mougins, France
- Saint-Etienne, France
- Villejuif, France
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lorient, France; Mougins, France; Saint-Etienne, France; Villejuif, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.