| NCT ID | NCT06659926 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Netherlands Cancer Institute |
| Condition | mCRPC |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-02-24 |
| Primary Completion | 2029-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-02-24 with a primary completion date of 2029-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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)
Contact & Investigator
J.C. van der Mijn
PRINCIPAL INVESTIGATOR
NKI-AvL
Frequently Asked Questions
Who can join the NCT06659926 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying mCRPC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06659926 currently recruiting?
Yes, NCT06659926 is actively recruiting participants. Contact the research team at k.vd.mijn@nki.nl for enrollment information.
Where is the NCT06659926 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands, Amersfoort, Netherlands, Nieuwegein, Netherlands, Utrecht, Netherlands and 1 additional location.
Who is sponsoring the NCT06659926 clinical trial?
NCT06659926 is sponsored by The Netherlands Cancer Institute. The principal investigator is J.C. van der Mijn at NKI-AvL. The trial plans to enroll 60 participants.