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 -
Key facts
- Where
- Amsterdam, HollandiaSee the site
- Phase
- 1/2. fázis
Where in Hollandia
- Amsterdam UMC StichtingAmsterdam, HollandiaToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Amsterdam UMC Stichting
- Trial code
- EU 2025-520482-52-03
- Record updated
- 2026. március 18.
- Original description
To prospectively investigate whether the ‘darolutamide FLARE phenomenon’, observed after the administration of the second line ARTA darolutamide in patients with prostate cancer, results in 1) a higher number of PSMA expressing prostate cancer deposits (either defined as local residual disease or metastatic disease) or 2) in a higher expression of PSMA in individual lesions (determined by SUVmax) on PSMA PET/CT.Read full original descriptionShow less
To prospectively investigate whether the ‘darolutamide FLARE phenomenon’, observed after the administration of the second line ARTA darolutamide in patients with prostate cancer, results in 1) a higher number of PSMA expressing prostate cancer deposits (either defined as local residual disease or metastatic disease) or 2) in a higher expression of PSMA in individual lesions (determined by SUVmax) on PSMA PET/CT.
Inclusion: Adult men (>18 years of age); Cohort 1 - PSMA PET/CT showing 1-5 metastases in bones and/or lymph nodes (miN1/M1ab); Cohort 2 - Patients with biochemical recurrent disease PSA 0.5-1.0 ng/mL (2 times) after RARP; Cohort 2 - miN0M0 on re-staging PSMA PET/CT; Any PSA, grade and stage of disease; Histologically proven prostate cancer; ECOG 0-1; Patients must have a life expectancy of >12 months; No prior hormonal therapy (including any androgen directed treatment such as bicalutamide, apalutamide, abiraterone or enzalutamide) or taxane based chemotherapy (docetaxel or cabazitaxel); Able to understand the patient information form (PIF); Signed informed consent; Cohort 1 - Previous robot-assisted radical prostatectomy or external beam radiotherapy.
Exclusion: Previous PSMA- based radioligand treatment; Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy; Prior hip replacement surgery potentially influencing performance of PSMA PET/CT; Any medical condition present that in the opinion of the investigator will affect patients’ clinical status when participating in this trial; Known hypersensitivity to the components of the study therapy or its analogues, specifically enzalutamide and/or darolutamide; Sjogren's syndrome; A second active malignancy other than prostate cancer; A known subtype other than prostate adenocarcinoma; Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception; Visceral (lung, liver) or brain metastases.