Actively Recruiting
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
Eligibility Criteria
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
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
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
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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