2025-520482-52-03Not yet recruitingPhase 1/2
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 -
Source: EU CTIS (euclinicaltrials.eu) · Last updated 18 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 19 Nov 2025
- Start date
- 1 Jan 2026
- Lead sponsor
- Amsterdam UMC Stichting
- Diseases
- Prostate cancer
- EU CT number
- 2025-520482-52-03
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 32
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.