NCT06659926Recruiting
The Radium-select Study
68Ga-PSMA-PET/CT and Genomic Alterations for Future Selection of Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) for Radium-223 Treatment.
Source: ClinicalTrials.gov · Last updated 8 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 16 Aug 2024
- Start date
- 24 Feb 2025
- Primary completion date
- 1 Jul 2029
- Lead sponsor
- The Netherlands Cancer Institute
- Diseases
- Prostate cancer
- NCT number
- NCT06659926
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 24 Feb 2025 to the primary completion date, 1 Jul 2029
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Meander Medisch Centrum Coordinator of this site? Confirm its status | Amersfoort | Netherlands | Recruiting |
| NKI-AVL Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Sint Antonius Ziekenhuis Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Recruiting |
| UMC Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
| Diakonessenhuis Coordinator of this site? Confirm its status | Utrecht | Netherlands | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.