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Scan to Help Choose Radium-223 Treatment for Advanced Prostate Cancer

Tests a PSMA PET scan to help select men with advanced prostate cancer for radium-223.

Plain-language title generated from the registry record
Registry title: The Radium-select Study

Key facts

Where
Amersfoort, Amsterdam, Nieuwegein, and Utrecht, NetherlandsSee the 5 sites

Where in Netherlands

  • Meander Medisch CentrumAmersfoort, NetherlandsTaking people
  • NKI-AVLAmsterdam, NetherlandsTaking people
  • Sint Antonius ZiekenhuisNieuwegein, NetherlandsTaking people
  • DiakonessenhuisUtrecht, NetherlandsNot yet recruiting
  • UMCUtrecht, NetherlandsTaking people

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Trial details

Who runs it
The Netherlands Cancer Institute
Trial code
NCT06659926
Record updated
8 July 2025
Original description
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.Read full original descriptionShow less

68Ga-PSMA-PET/CT and Genomic Alterations for Future Selection of Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) for Radium-223 Treatment.

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.

Inclusion: 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: 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).

ClinicalTrials.gov NCT06659926