Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT06659926

The Radium-select Study

Led by The Netherlands Cancer Institute · Updated on 2025-07-08

60

Participants Needed

5

Research Sites

226 weeks

Total Duration

On this page

Sponsors

T

The Netherlands Cancer Institute

Lead Sponsor

B

Bayer

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

The Radium-select Study

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed adenocarcinoma of the prostate
  • Progressive disease after previous treatment shown by rising PSA or imaging
  • Positive bone scan showing at least two bone metastases
  • Hemoglobin concentration above 10 g/dl and platelet count above 100 x 10^9/l
  • Receiving bone protective agents and androgen deprivation therapy as per guidelines
Not Eligible

You will not qualify if you...

  • ECOG performance score greater than 2
  • Life expectancy less than 6 months
  • Presence of extra-skeletal metastases or lymph nodes larger than 3 cm on conventional imaging

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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2
3
+1

Trial Site Locations

Total: 5 locations

1

NKI-AVL

Amsterdam, North Holland, Netherlands, 1066CX

Actively Recruiting

2

Meander Medisch Centrum

Amersfoort, Utrecht, Netherlands, 3813TZ

Actively Recruiting

3

Sint Antonius ziekenhuis

Nieuwegein, Utrecht, Netherlands, 3430EM

Actively Recruiting

4

Diakonessenhuis

Utrecht, Netherlands, 3582KE

Not Yet Recruiting

5

UMC

Utrecht, Netherlands, 3584CX

Actively Recruiting

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Research Team

J

J.C. van der Mijn, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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