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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: 2023-509787-15-00
What this study is testing
The primary objective of this study is to assess the efficacy of darolutamide and of a stereotactic dose escalated radiotherapy targeting prostate in combination with ADT and pelvic nodal radiotherapy in terms of metastasis-free survival (MSF), in patients with localised prostate cancer and high-risk features of relapse (defined as patients having at least 2 high-risk criteria from the NCCN classification) in a 2 by 2-factorial trial.
- 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
- Haemoglobin ≥ 90 g/L (in absence of red blood cell transfusion within 4 weeks prior to randomisation)
- Hepatic function: serum alanine aminotransferase (ALT) and/or aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN
- Creatinine ≤ 2.0 x ULN
- Sexually active patients must agree to use an effective contraceptive method while on treatment and for 1 week after the final dose of investigational product
- Patient must be affiliated to a Social Security System or in possession of equivalent private health insurance (according to local regulations for participation in clinical trials)
You likely can't join if
- Clinically or radiologically detectable metastasis, defined as: - Any bone or visceral disease on PSMA PET/CT or conventional imaging - Any non-pelvic nodal metastasis on PSMA PET/CT or conventional imaging - Any enlarged pelvic lymph node (≥ 1 cm in small diameter) on conventional imaging (CT scan or MRI). Note: Patients with infra-centimetric pelvic nodal disease (< 1 cm in small diameter) on conventional imaging can be included even if they have PSMA PET/CT suggestive of pelvic nodal metastasis.
- Other prior malignancies within the last 3 years, except basal cell skin cancer
- Known hypersensitivity to the study treatment or any of its ingredients
- Physical or psychological condition or any condition that in the opinion of the investigator would impair the patients' ability to comply with the study procedures
- Previous treatment for prostate cancer (surgery or radiotherapy) or previous pelvic irradiation that would make prostate/pelvis radiotherapy impossible
- Concomitant prohibited treatment. Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5. A one-week washout period is necessary for patients who are already on these treatments
See the full eligibility criteria
Who can join
- Signed a written informed consent form prior to any trial specific procedures
- Haemoglobin ≥ 90 g/L (in absence of red blood cell transfusion within 4 weeks prior to randomisation)
- Hepatic function: serum alanine aminotransferase (ALT) and/or aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN
- Creatinine ≤ 2.0 x ULN
- Sexually active patients must agree to use an effective contraceptive method while on treatment and for 1 week after the final dose of investigational product
- Patient must be affiliated to a Social Security System or in possession of equivalent private health insurance (according to local regulations for participation in clinical trials)
- Patient must be 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, 18 years ≤ Age ≤ 80 years
- ECOG performance status of 0 or 1
- No significant co-morbidities that might prevent long-term follow-up
- Histologically confirmed adenocarcinoma of the prostate
- Meet at least 2 of the following criteria from NCCN classification
- Prostate size on MRI < 100 cc
- Absolute neutrophil count ≥ 1.5 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
What rules you out
- Clinically or radiologically detectable metastasis, defined as: - Any bone or visceral disease on PSMA PET/CT or conventional imaging - Any non-pelvic nodal metastasis on PSMA PET/CT or conventional imaging - Any enlarged pelvic lymph node (≥ 1 cm in small diameter) on conventional imaging (CT scan or MRI). Note: Patients with infra-centimetric pelvic nodal disease (< 1 cm in small diameter) on conventional imaging can be included even if they have PSMA PET/CT suggestive of pelvic nodal metastasis.
- Other prior malignancies within the last 3 years, except basal cell skin cancer
- Known hypersensitivity to the study treatment or any of its ingredients
- Physical or psychological condition or any condition that in the opinion of the investigator would impair the patients' ability to comply with the study procedures
- Previous treatment for prostate cancer (surgery or radiotherapy) or previous pelvic irradiation that would make prostate/pelvis radiotherapy impossible
- Concomitant prohibited treatment. Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5. A one-week washout period is necessary for patients who are already on these treatments
- Prior treatment with second generation androgen receptor (AR) inhibitors, other investigational AR inhibitors, or CYP17 enzyme inhibitor
- Use of oestrogens or 5-α reductase inhibitors or AR inhibitors
- Acute toxicities of prior treatments and procedures not resolved to grade ≤ 1 or baseline before randomisation.
- Prior chemotherapy or immunotherapy for prostate cancer.
- Major surgery within 28 days before randomisation
- Recent history of TURP or prostate enucleation (less than 6 months)
- Participation in another therapeutic trial within 30 days prior to inclusion
- Persons deprived of their liberty or under protective custody or guardianship
- Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons
- Prior treatment for prostate cancer except lymph node dissection (i.e. patients with PN- disease only can be included) or ADT (started more than 6 weeks before randomisation).
- Patient with other known concurrent severe and/or uncontrolled concurrent medical disease or infection (such as active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease) or co-morbidity, which could compromise participation in the study.
- Cardiac disease such as uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg; 3 consecutive measures taken 5 minutes apart), stroke, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within one year, coronary/peripheral artery bypass graft, LVEF > grade 2,
- Uncontrolled diabetes mellitus
- Current active hepatic or biliary disease (with exception of subjects with Gilbert's syndrome, asymptomatic gallstones, stable chronic liver disease per investigator assessment)
- Gastrointestinal disorder or procedure, which expects to interfere significantly with absorption of study treatment. Severe GI disorders precluding pelvic irradiation
- Known severely impaired lung function (spirometry and DLCO 70% or less of normal and O2 saturation of 88% or less at rest on room air)
The study team makes the final eligibility decision.
Where it's taking place
- Australia
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.
Where is this trial taking place?
Study sites include Australia. 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.