BridgeMD
New treatment option for Prostate Cancer
Official title Evaluation of dAroLutamide Addition to anDrogen Deprivation Therapy and radIatioN Therapy in Newly Diagnosed Prostate Cancer With Pelvic Lymph Nodes Metastases
ClinicalTrials.gov ID: NCT05116475
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 prostate cancer.
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
- Prospective, multicenter, comparative, randomized placebo-controlled Phase III trial - patients with hormone-naïve prostate cancer and pelvic lymph nodes metastases
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, 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 to 120, men only
You may be able to join if
- . Newly diagnosed, histologically confirmed prostate adenocarcinoma
- ≥ 18 years old.
- Initial staging with Pelvic MRI, body CT-scan/bone scan or Choline or PSMA PET-CT
- Any T stage
- N stage: N1 - Pelvis lymph nodes metastases (upper limit defined as the L4/L5 interspace).
You likely can't join if
- Lymph nodes metastases outside of the pelvis
- Bone or visceral metastases
- Prior systemic therapy for locally-advanced prostate cancer except for LH-RH agonist or antagonist up to 3 months before randomization
- Prior treatment with:
- Second generation AR inhibitors such as enzalutamide, apalutamide (ARN-509), darolutamide (ODM-201) other investigational AR inhibitors
- CYP17 enzyme inhibitor such as abiraterone acetate, TAK-700 or
See the full eligibility criteria
- . Newly diagnosed, histologically confirmed prostate adenocarcinoma
- ≥ 18 years old.
- Initial staging with Pelvic MRI, body CT-scan/bone scan or Choline or PSMA PET-CT
- Any T stage
- N stage: N1 - Pelvis lymph nodes metastases (upper limit defined as the L4/L5 interspace).
- Intention to treat with long-term androgen deprivation therapy (24 months).
- Hormonal therapy with LH-RH agonist or antagonist is allowed up to 3months prior to randomization.
- Able to receive protocol therapy and have life expectancy of at least 36 months, ECOG Performance Status (PS) 0-2.
- . Blood counts at screening: hemoglobin ≥ 9.0 g/dl, absolute neutrophil count ≥ 1500/μl (1.5x109/l), platelet count ≥ 100,000/μl (100x109/l ) (patient must not have received any growth factor or blood transfusion within...
- Screening values of serum alanine aminotransferase (ALT) and/or aspartate transaminase (AST) \< 2.5 x upper limit of normal (ULN), total bilirubin \< 1.5 x ULN (except patients with a diagnosis of Gilbert's disease)...
- Sexually active patients, unless surgically sterile, must agree to use condoms as an effective barrier method during the study treatment and for 3 months after the end of the study treatment.
- Written informed consent.
- Willing and expected to comply with follow-up schedule.
- Affiliated to the social security system.
- Use of 5-α reductase inhibitors (finasteride, dutasteride) is allowed
- Lymph nodes metastases outside of the pelvis
- Bone or visceral metastases
- Prior systemic therapy for locally-advanced prostate cancer except for LH-RH agonist or antagonist up to 3 months before randomization
- Prior treatment with:
- Second generation AR inhibitors such as enzalutamide, apalutamide (ARN-509), darolutamide (ODM-201) other investigational AR inhibitors
- CYP17 enzyme inhibitor such as abiraterone acetate, TAK-700 or
- Oral ketoconazole
- Use of estrogens, or AR inhibitors (bicalutamide, flutamide, nilutamide, cyproterone acetate)
- Use of systemic corticosteroid with dose greater than the equivalent 10 mg of prednisone/day within 28 days before randomization.
- Patients with QTor QTc interval \> 450 ms on the ECG
- Initiation of treatment with bisphosphonate or denosumab within 12 weeks before randomization. Patients receiving bone loss prevention treatment on a stable dose of e.g. bisphosphonate or denosumab for at least 28 days...
- Known hypersensitivity to the study treatment (RT, ADT, darolutamide/placebo) or any of its ingredients.
- Major surgery within 28 days before randomization.
- Any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association...
- Uncontrolled hypertension as indicated by a resting systolic BP \> 160 mmHg or diastolic BP \> 100 mmHg at screening. Patients may be re-screened after adjustments of anti- hypertensive medications.
- Prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e. pTis, pTa, and pT1) is allowed, as well as...
- Gastrointestinal disorder or procedure which expects to interfere significantly with absorption of study treatment.
- Active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease.
- Participation in another treatment clinical trial and any concurrent treatment with any investigational drug
- Any condition that in the opinion of the investigator would impair the patients' ability to comply with the study procedures.
- Unable to swallow study medications and comply with study requirements.
- Galactose intolerance, the Lapp lactase deficiency or glucose galactose-malabsorption
- History of bilateral hip replacements making IMRT impossible
- Contra-indications for the administration of any of the study treatments (RT, ADT, Darolutamide/placebo) or any of its ingredients.
- Patient under guardianship, administrative tutorship and incapable to give informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Chambray-lès-Tours, 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 to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chambray-lès-Tours, 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.