The Radium-select Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorThe Netherlands Cancer Institute
About this trial
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
Qualifiers
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.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- 68Ga-PSMA-PET/CT scan
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
The Netherlands Cancer Institute
Lead sponsor
Bayer
Collaborator
Source ClinicalTrials.gov