Clinical Application of the Androgen Receptor Inhibitor Darolutamide to Upregulate the Prostate-Specific Membrane Antigen (PSMA) Protein Expression in Patients with Hormone Sensitive Prostate Cancer. - The DARO-flare Trial -

Condition studied

Prostate cancer

Investigational medicinal product(s)

Eligibility

Primary endpoint

Number of lesions, Size of lesions, measured in mm, Location of lesions, distinguished in lymph node, bone, visceral, other, SUVmax, 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), Cohort 1 - A clinical significant increase in SUVmax of existing lesions (≥20%), 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), 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), Cohort 2 - The detection of local recurrence of disease in the absence of metastatic disease with a SUVmax > liver (according to SPARC guidelines), 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)

Endpoint detail

Number of lesions, Size of lesions, measured in mm, Location of lesions, distinguished in lymph node, bone, visceral, other, SUVmax, Questionnaire on health-related quality of life, Number of AE and SAE, recorded by NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0)