Status:
RECRUITING
Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging
Lead Sponsor:
UNICANCER
Collaborating Sponsors:
Bayer
Conditions:
Prostatic Cancer, Castration-Resistant
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
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 gro...
Detailed Description
PEACE 8 is a phase III open-label, randomised (patients are randomly assigned to treatment), international, multicentre trial, evaluating the benefit of adding SBRT to darolutamide for treating patien...
Eligibility Criteria
Inclusion Criteria:
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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 investigator or the sponsor, can confirm in writing the patient's consent.
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Patients aged ≥18 years.
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Patient with histologically confirmed of adenocarcinoma prostate cancer without small cell or pure endocrine features.
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Patient with a history of local treatment with curative intent for localised prostate cancer, including surgery or radiotherapy.
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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.
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Detection of 1 to 5 metastatic sites (pelvic lymph nodes included) on new generation PET using either choline, fluciclovine, or PSMA as tracer.
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All metastatic sites must be amenable to stereotactic radiation therapy.
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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.
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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 the presence of liver metastases).
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Adequate liver function with bilirubin <3 mg/dL and albumin >2.5 g/dL.
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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 criteria.
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Adequate kidney function with a creatinine clearance >30 mL/min (Cockcroft-Gault).
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Patient with Eastern Cooperative Oncology group (ECOG) performance status (PS) ≤1.
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Patient is willing to use contraceptive during and for at least 1 week after discontinuing darolutamide.
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Patient affiliated to the social security system (or equivalent according to local regulations for participation in clinical trials).
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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.
Exclusion Criteria:
- 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 (NYHA) Class III or IV.
- 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.
Key Trial Info
Start Date :
October 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 7 2032
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT06276465
Start Date
October 7 2024
End Date
October 7 2032
Last Update
December 20 2024
Active Locations (4)
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1
Groupe Hospitalier Bretagne Sud
Lorient, France, 56322
2
Centre Azuréen de Cancérologie
Mougins, France, 06250
3
CHU de Saint-Etienne
Saint-Etienne, France, 42055
4
Gustave Roussy Cancer Campus
Villejuif, France, 94805