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DARIUS : A randomized non-comparative phase II multicentric trial on short term DARolutamide (ODM-201) concomitant to radiation therapy for patients with Intermediate Unfavorable risk proState cancer.
EU CTIS ID: 2023-509494-23-00
What this study is testing
- To assess the preliminary signs of antitumor activitity of darolutamide when prescribed for 6 months in association with radiotherapy in patients with unfavorable intermediate risk prostate cancer. - Activity will be measured in terms of biological response defined as PSA ≤0.1ng/ml and measured 6 months after randomization.
- Therapeutic exploratory (Phase II)
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
- Age ≥ 18,
- Available archived paraffin-embedded tumor sample for research purpose,
- Patients with a social security in compliance with the french law,
- Voluntary signed and dated written informed consent prior to any study specific procedure,
- Men must agree to use an effective method of contraception throughout the treatment period and for one week after discontinuation of treatment. Acceptable methods of contraception are described in protocol section 7.1.4.
- Histological diagnosis of prostate malignancy cancer
You likely can't join if
- Stage T3b-T4 prostate cancer by clinical examination or radiologic evaluation,
- Patients having received ketoconazole, finasteride or dutasteride within 30 days of inclusion,
- Previous and current malignancies other than prostate cancer within the last 5 years with the exception of adequately treated basal cell or squamous cell carcinoma of the skin, acute lymphoblastic leukemia, non-muscle invasive bladder cancer,
- Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection),
- History of cerebrovascular accident (within the last 6 months)
- Impaired cardiac function including any one of the following: o Clinically documented myocardial infarction (within the last 6 months) o History of severe/unstable angina (within the last 6 months) o History of peripheral artery/coronary bypass surgery (within the last 6 months) o History of or presence of congestive heart failure according to the New York Heart Association (NYHA) class 3 or 4 with LVEF < 45% or below the institutional lower limit of the normal range (whichever is higher) as determined by locally read echocardiogram or multi-gated acquisition scan performed in the last 6 months o History of or presence of risk factors for QT interval prolongation o History of or presence of clinically significant ventricular or atrial tachy-arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes) o Clinically significant resting bradycardia (< 50 beats per minute) o History of Mobitz II second degree or third degree heart block without use of ventricular-paced pacemaker o History of or presence of clinically significant hypotension (e.g. systolic blood pressure < 86 mmHg on 2 consecutive measurements) o ECG demonstrating equal to or greater than grade III toxicity according the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Note: patients with cardiac disease controlled under treatment are eligible.
See the full eligibility criteria
Who can join
- Age ≥ 18,
- Available archived paraffin-embedded tumor sample for research purpose,
- Patients with a social security in compliance with the french law,
- Voluntary signed and dated written informed consent prior to any study specific procedure,
- Men must agree to use an effective method of contraception throughout the treatment period and for one week after discontinuation of treatment. Acceptable methods of contraception are described in protocol section 7.1.4.
- Histological diagnosis of prostate malignancy cancer
- Cancer without loco-regional or distant metastasis (tumor assessment must comprise at least Pelvic MRI AND thoraco-abdomino-pelvic contrast-enhanced CT-Scan AND Bone Scintigraphy. (Note that 1) a contrast-injected scintigraphy or a PET-CT scan with injection of choline or PSMA product can replace bone scintigraphy and the TAP scan, 2) additional assessment by PET-Scan is allowed as per investigator judgement),
- Unfavorable intermediate risk prostate cancer diagnosis defined by the NCCN Guidelines. One of the following criteria is sufficient to define an unfavorable intermediate risk prostate cancer: a) Gleason = 7 (4+3) b) ≥ 50% of thecore of biopsies need to be positive for adenocarcinoma. Note that in case of targeted biopsy, this criterion is valide only if randomized biopsies were also performed. If these criteria are not being identified, two or three of the following criteria are necessary to define unfavorable intermediate risk prostate cancer: c) PSA value between 10-20 ng/ml d) Gleason 7 (3+4) or 6 e) T2b (clinical or radiological) Note: patients with iT3a (extraprostatic extension) can be included only if gleason score is 6 and PSA less than 20 [22].
- Patients newly diagnosed with an unfavorable intermediate risk prostate cancer according to the protocol criteria or previously diagnosed with low risk (Gleason score < 6, clinical stage < T2a, and PSA< 10) prostate cancer progressing to eligible risk disease according to the protocol criteria within 30 days before registration
- Patients must have a life expectancy of at least 5 years,
- Performance status ECOG ≤ 2,
- Patients without contra-indications to EBRT as per physician judgement,
- Patients with adequate organ function defined by all the following laboratory values (< ULN (Upper Limit of Normal)) : 1. Hemoglobin ≥ 9 g/dL, 2. Neutrophils ≥ 1.5 G/L 3. Platelets ≥ 80 G/L 4. Total bilirubin < 2X ULN 5. AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN 6. Calculated creatinine clearance (CrCl) ≥ 30 ml/min (according to Cockroft and Gault formula)
What rules you out
- Stage T3b-T4 prostate cancer by clinical examination or radiologic evaluation,
- Patients having received ketoconazole, finasteride or dutasteride within 30 days of inclusion,
- Previous and current malignancies other than prostate cancer within the last 5 years with the exception of adequately treated basal cell or squamous cell carcinoma of the skin, acute lymphoblastic leukemia, non-muscle invasive bladder cancer,
- Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection),
- History of cerebrovascular accident (within the last 6 months)
- Impaired cardiac function including any one of the following: o Clinically documented myocardial infarction (within the last 6 months) o History of severe/unstable angina (within the last 6 months) o History of peripheral artery/coronary bypass surgery (within the last 6 months) o History of or presence of congestive heart failure according to the New York Heart Association (NYHA) class 3 or 4 with LVEF < 45% or below the institutional lower limit of the normal range (whichever is higher) as determined by locally read echocardiogram or multi-gated acquisition scan performed in the last 6 months o History of or presence of risk factors for QT interval prolongation o History of or presence of clinically significant ventricular or atrial tachy-arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes) o Clinically significant resting bradycardia (< 50 beats per minute) o History of Mobitz II second degree or third degree heart block without use of ventricular-paced pacemaker o History of or presence of clinically significant hypotension (e.g. systolic blood pressure < 86 mmHg on 2 consecutive measurements) o ECG demonstrating equal to or greater than grade III toxicity according the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Note: patients with cardiac disease controlled under treatment are eligible.
- Uncontrolled hypertension
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery),
- Major surgery within 4 weeks prior enrolment except pelvic lymph-nodes dissection (extended or limited),
- Known hypersensitivity to any involved study drug or of its formulation components, to natural gonadotrophin releasing hormone (GnRH) or its analogues
- Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome
- Patients with Gleason score ≥8,
- Men who are not using an effective method of contraception as previously described
- Use of herbal or alternative remedies that may affect hormonal status such as Prostasol or PC-SPES,
- History of non-compliance to medical regimens or inability to grant consent,
- Patient unable to follow and comply with the study procedures because of any geographical, social or psychpsychological reasons,
- Individuals under judicial protection or deprived of liberty.
- Inability to swallow or to give subcutaneous or intramuscular injections.
- Patients with PSA >20 ng/ml,
- Presence of loco-regional or distant metastasis (MRI/CT-Scan and Bone Scintigraphy),
- Contra-indications to MRI and to contrast-enhanced CT-scan,
- Hypogonadism or severe androgen deficiency as defined by screening serum testosterone less than 50 ng/dL or below the normal range for the institution.
- Previous prostate cancer treated by androgen deprivation, chemotherapy, surgery, or radiotherapy,
- Patients with previous bilateral orchidectomy
- Patients actively receiving or having received within 6 months prior enrollment any concurrent androgens, anti-androgens, estrogens, or progestational agents,
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.
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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.