The Radium-select Study

Recruiting now · Not applicable

Conditions studied: mCRPC, Male Urogenital Diseases

In brief

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.

Key facts

Study ID

NCT06659926

Run by

The Netherlands Cancer Institute

People needed

60

Starts

2025-02-24

Expected to finish

2029-07-01

Last updated by the study team

2025-07-08

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• NKI-AVL — Amsterdam, North Holland, Netherlands (enrolling)
• Meander Medisch Centrum — Amersfoort, Utrecht, Netherlands (enrolling)
• Sint Antonius ziekenhuis — Nieuwegein, Utrecht, Netherlands (enrolling)
• UMC — Utrecht, Netherlands (enrolling)
• Diakonessenhuis — Utrecht, Netherlands

Full record on ClinicalTrials.gov

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