DAROLUTAMIDE for Prostate cancer|Hormone-sensitive prostate cancer

Inclusion criteria

• {"criterion_text":"- Adult men (>18 years of age)\n- Cohort 1 - PSMA PET/CT showing 1-5 metastases in bones and/or lymph nodes (miN1/M1ab)\n- Cohort 2 -\tPatients with biochemical recurrent disease PSA 0.5-1.0 ng/mL (2 times) after RARP\n- Cohort 2 - miN0M0 on re-staging PSMA PET/CT\n- Any PSA, grade and stage of disease\n- Histologically proven prostate cancer\n- ECOG 0-1\n- Patients must have a life expectancy of >12 months\n- No prior hormonal therapy (including any androgen directed treatment such as bicalutamide, apalutamide, abiraterone or enzalutamide) or taxane based chemotherapy (docetaxel or cabazitaxel)\n- Able to understand the patient information form (PIF)\n- Signed informed consent\n- Cohort 1 - Previous robot-assisted radical prostatectomy or external beam radiotherapy"}

Exclusion criteria

• {"criterion_text":"- A known subtype other than prostate adenocarcinoma\n- Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception\n- Previous PSMA- based radioligand treatment\n- Visceral (lung, liver) or brain metastases\n- Any medical condition present that in the opinion of the investigator will affect patients’ clinical status when participating in this trial\n- Known hypersensitivity to the components of the study therapy or its analogues, specifically enzalutamide and/or darolutamide\n- Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy\n- Prior hip replacement surgery potentially influencing performance of PSMA PET/CT\n- Sjogren's syndrome\n- A second active malignancy other than prostate cancer"}

Primary endpoints

• {"endpoint_text":"- Number of lesions\n- Size of lesions, measured in mm\n- Location of lesions, distinguished in lymph node, bone, visceral, other\n- SUVmax\n- Cohort 1 - The appearance of at least 1 new PSMA-positive lesion compared to baseline PSMA PET/CT, with a SUVmax > liver (according to SPARC guidelines)\n- Cohort 1 - A clinical significant increase in SUVmax of existing lesions (≥20%)\n- Cohort 1 - An increase in the total number of metastatic lesions above 5 compared to baseline PSMA PET/CT (shifting from an oligo-metastatic to poly-metastatic disease stage)\n- Cohort 2 - The appearance of at least 1 metastatic lesion (lymph node or bone) suspicious for prostate cancer with a SUVmax > liver (according to SPARC guidelines)\n- Cohort 2 - The detection of local recurrence of disease in the absence of metastatic disease with a SUVmax > liver (according to SPARC guidelines)\n- Cohort 2 - The detection of local recurrence of disease with local or a metastatic lesion suspicious for prostate cancer with either of the two having a SUVmax > liver (according to SPARC guidelines)","definition_or_measurement_approach":"- Number of lesions: (no additional measurement definition provided in source)\n- Size of lesions, measured in mm: lesion size measured in millimetres\n- Location of lesions: categorised as lymph node, bone, visceral, other\n- SUVmax: standard uptake value maximum (SUVmax)\n- Cohort 1 new PSMA-positive lesion: defined as lesion with SUVmax > liver (according to SPARC guidelines) on PSMA PET/CT compared to baseline\n- Cohort 1 clinically significant increase in SUVmax: defined as ≥20% increase in SUVmax of existing lesions\n- Cohort 1 increase to >5 metastatic lesions: comparison to baseline PSMA PET/CT (shift from oligo- to poly-metastatic)\n- Cohort 2 appearance of metastatic lesion: lesion suspicious for prostate cancer with SUVmax > liver (according to SPARC guidelines)\n- Cohort 2 detection of local recurrence in absence of metastatic disease: lesion with SUVmax > liver (according to SPARC guidelines)\n- Cohort 2 detection of local recurrence with local or metastatic lesion: either lesion having SUVmax > liver (according to SPARC guidelines)"}

Secondary endpoints

• {"endpoint_text":"- Number of lesions\n- Size of lesions, measured in mm\n- Location of lesions, distinguished in lymph node, bone, visceral, other\n- SUVmax\n- Questionnaire on health-related quality of life\n- Number of AE and SAE, recorded by NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0)","definition_or_measurement_approach":"- Number of lesions: (no additional measurement definition provided in source)\n- Size of lesions, measured in mm: lesion size measured in millimetres\n- Location of lesions: categorised as lymph node, bone, visceral, other\n- SUVmax: standard uptake value maximum (SUVmax)\n- Questionnaire on health-related quality of life: patient-reported questionnaire (QLQ-C30 and QLQ-PR25 documents listed)\n- Number of AE and SAE: recorded using NCI CTCAE v5.0"}

Netherlands

Earliest CTIS Part Ii Submission Date

28-11-2025

Latest Decision Or Authorization Date

18-03-2026

Processing Time Days

110

Number Of Sites

1

Number Of Participants

32

Primary sponsor

Full Name

Amsterdam UMC Stichting

Organisation Type

Patient organisation/association

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"Bayer B.V.","duties_or_roles":"Source of monetary support","organisation_type":""}