The Radium-select Study
Recruiting · NCT06659926 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Radium-223 is an established radionuclide therapy for patients with metastatic castration resistant prostate cancer (mCRPC) and symptomatic bone metastasis. Patients are eligible for this treatment when they have mCRPC and bone metastases; limited extraskeletal lesions (local prostate, lymph nodes \<3 cm) on conventional contrast enhanced CT (ceCT) were allowed in the registration trial(1). Previous research revealed that extraskeletal disease on ceCT and bone scans correlates with a poor response. Meanwhile, 68Ga-PSMA-PET/CT emerged as more sensitive imaging strategy that increases the detection of extraskeletal prostate cancer metastases. It is unclear whether these extraskeletal lesions harbour any predictive value in the treatment of mCRPC patients with Radium-223.
Who can take part
Inclusion criteria
- Histologically confirmed adenocarcinoma of the prostate.
- Progressive disease after previous treatment defined as a rise in serum (Prostate Specific Antigen) PSA (PCWG3 criteria(22), see appendix 1) and/or progression on conventional imaging (PCWG3).
- A positive bone scan (osteoblastic bone metastases), with at least two metastases.
- Hemoglobin concentration \>10 g/dl (6.2 mmol/l) and thrombocytes \>100 109/I at baseline.
- Each patient will need to (continue to) receive adequate bone protective agents (e.g. bisphosphonates) and androgen deprivation therapy (ADT) according to current clinical guidelines.
Exclusion criteria
- Eastern Cooperative Oncology Group (ECOG) performance score \>2
- Life expectancy \< 6 months.
- Detected extra-skeletal metastases or lymph node metastases (\>3 cm short axis) as identified by conventional imaging (ceCT thorax/abdomen)
Where it is running
5 locations listed.
- Diakonessenhuis - Utrecht, Netherlands
- UMC - Utrecht, Netherlands
- NKI-AVL - Amsterdam, North Holland, Netherlands
- Meander Medisch Centrum - Amersfoort, Utrecht, Netherlands
- Sint Antonius ziekenhuis - Nieuwegein, Utrecht, Netherlands