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Randomised phase III trial of ADT +/- darolutamide in frail men with castration-naïve de novo metastatic prostate cancer
EU CTIS ID: 2022-502425-18-00
What this study is testing
To compare the efficacy of ADT + darolutamide vs ADT + placebo in terms of radiographic progression-free survival in patients with castration-naïve de novo metastatic prostate cancer with vulnerable functional ability and not elected for docetaxel or other androgen receptor pathway inhibitors.
- 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
- Signed a written informed consent form prior to any trial specific procedures.
- For sexually active men, agreement to use adequate contraception for the duration of trial participation and up to 2 weeks after completing study treatment
- Affiliated to the social security system or in possession of equivalent private health insurance (according to local regulations for participation in clinical trials)
- 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.
- Men with histologically or cytologically confirmed adenocarcinoma of the prostate.
- Aged ≥18 years old at the time of signing informed consent
You likely can't join if
- Three or more Grade 3, or any Grade 4 events on the CISR-G questionnaire.
- Prior malignancy ≤ 3 years before study enrolment. 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 any localized cancer for which treatment has been completed ≥6 months before randomisation and from which the subject has been disease-free, or for which the risk of relapse is less than 30%, as well as early stage chronic lymphocytic leukaemia that does not require any specific treatment.
- Inability to swallow oral medications
- Gastrointestinal disorder or procedure that can be expected to interfere significantly with the absorption of study treatment.
- Known to have active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease at screening.
- Treatment with any investigational product within 28 days before randomisation.
See the full eligibility criteria
Who can join
- Signed a written informed consent form prior to any trial specific procedures.
- For sexually active men, agreement to use adequate contraception for the duration of trial participation and up to 2 weeks after completing study treatment
- Affiliated to the social security system or in possession of equivalent private health insurance (according to local regulations for participation in clinical trials)
- 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.
- Men with histologically or cytologically confirmed adenocarcinoma of the prostate.
- Aged ≥18 years old at the time of signing informed consent
- De novo metastatic disease defined by clinical or radiographic evidence of metastases.
- Measurable disease or bone lesions that are evaluable according to PCWG3 criteria
- Ineligible for treatment with all of the following drugs: docetaxel, abiraterone, enzalutamide, apalutamide; AND meets at least one of the frailty criteria
- Adequate bone marrow function: haemoglobin ≥80g/L, white blood cells ≥ 3.0 x109/L and platelets ≥80 x109/L.
- Adequate liver function: alanine aminotransferase (ALT) < 2 xULN and bilirubin < 1.5 xULN, (or if bilirubin is between 1.5-2x ULN, they must have a normal conjugated bilirubin). For patients with documented liver metastasis ALT < 5 xULN is acceptable
- Adequate renal function: calculated creatinine clearance > 30 ml/min (using the MDRD or CKD EPI method)
What rules you out
- Three or more Grade 3, or any Grade 4 events on the CISR-G questionnaire.
- Prior malignancy ≤ 3 years before study enrolment. 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 any localized cancer for which treatment has been completed ≥6 months before randomisation and from which the subject has been disease-free, or for which the risk of relapse is less than 30%, as well as early stage chronic lymphocytic leukaemia that does not require any specific treatment.
- Inability to swallow oral medications
- Gastrointestinal disorder or procedure that can be expected to interfere significantly with the absorption of study treatment.
- Known to have active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease at screening.
- Treatment with any investigational product within 28 days before randomisation.
- Concurrent participation in another clinical trial involving an investigational product (patients enrolled in non-experimental trials with no modification of the standard of care can be included).
- Individual of full age deprived of liberty or placed under a legal protection measure (tutorship/curatorship/temporary guardianship).
- Significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule or any condition that, in the opinion of the investigator, would preclude participation in this trial.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≥3
- Hypertension not controlled by an anti-hypertensive treatment (systolic blood pressure [BP] ≥ 160 mmHg or diastolic BP ≥ 95 mmHg; 3 consecutive measures taken 5 minutes apart).
- Acute toxicities of prior treatments and procedures not resolved to grade ≤ 1 or baseline before randomisation with the exception of hot flushes and erectile dysfunction.
- Previous systemic treatment for prostate cancer, except less than 12 weeks of ADT and/or an old-generation AR inhibitor.
- Severe or uncontrolled concurrent disease, infection or co-morbidity.
- Known hypersensitivity to the study treatment or any of its ingredients.
- Major surgery within 28 days before randomisation.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. 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 EU CTIS; the study team decides eligibility.