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Darolutamide to increase PSMA levels in hormone sensitive prostate cancer, the DARO-flare trial

Tests whether darolutamide raises PSMA on scans in men with prostate cancer.

Key facts

Who runs it
Amsterdam UMC Stichting
Where
Amsterdam, NetherlandsSee the site
Registry title
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 -
Status
Not yet recruiting
Phase
Phase 1/2
People taking part
32 people, planned
Started
1 Jan 2026
Expected to end
31 Dec 2026
Type of study
Interventional
Record updated
18 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adult men with prostate cancer that was proven by tissue testing and who have had no hormone therapy or taxane chemotherapy. It studies how the drug darolutamide changes PSMA on PSMA PET/CT scans.

Age
Adults over 18 years.
Sex
Men only.
Disease stage
Cohort 1: 1-5 metastases in bones and/or lymph nodes on PSMA PET/CT. Cohort 2: PSA coming back at 0.5-1.0 ng/mL (2 times) after robot-assisted radical prostatectomy, with no visible spread on re-staging PSMA PET/CT.
Earlier treatment
No earlier hormone therapy (for example bicalutamide, apalutamide, abiraterone or enzalutamide) and no taxane chemotherapy (docetaxel or cabazitaxel). Cohort 1: earlier robot-assisted radical prostatectomy or external beam radiotherapy.
Biomarker or test result
PSMA PET/CT result as described for each cohort.

Main reasons for not taking part

  • Cancer type other than prostate adenocarcinoma
  • Earlier PSMA-based radioligand treatment
  • Cancer spread to lung, liver or brain
  • Prior hip replacement surgery that may affect the PSMA PET/CT
  • Sjogren's syndrome or a second active cancer

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Netherlands

  • Amsterdam UMC StichtingAmsterdam, NetherlandsNot yet recruiting

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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 -
Plain-language title
Darolutamide to increase PSMA levels in hormone sensitive prostate cancer, the DARO-flare trialGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
18 March 2026