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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
68Ga-PSMA-PET/CT scan
Other intervention68Ga-PSMA-PET/CT scan at baseline and will be followed throughout the treatment with online patient reported outcome measure (PROM) questionnaires (Kaiku application) and blood sampling for circulating tumor DNA (ctDNA) analysis. At clinical progression, each patient will undergo a second 68Ga-PSMA-PET/CT to determine the location of disease progression and assess the value of 68Ga-PSMA-PET/CT imaging as a response measure
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: mCRPC patients with bone-only disease according to 68Ga-PSMA-PET/CTOther 1 intervention
Trial outcomes
Primary outcomes
1
Clinical progression free survival (cPFS)
The primary study endpoint will be clinical progression free survival (cPFS) in 30 patients with bone-only disease according to PSMA PET/CT.
Time frame
Up to 28 weeksSecondary outcomes
1
Patient reported outcome measures ( PROMs).
complete questionnaires on health related quality of life (HRQoL), including the (Functional Assessment of Cancer Therapy) FACT-P: Score 1 to 4, Brief pain Inventory (BPI-SF): scale score from 1 to 10, and analgesics use; name, dosing, frequence and after every treatment cycle.
Time frame
In screening and cycle 2,3,4,5,6 (every 4 weeks) and with progression2
Overall survival (OS)
OS will be defined as time from first Radium-223 treatment to the date of death, or censored at last follow-up.
Time frame
In Follow up (q6months, max 24 months)3
Baseline and changes in 68 Ga-PSMA-PET-CT parameters
Baseline and changes in 68Ga-PSMA-PET/CT parameters (disease localizations, extent of disease, tumor volume).
Time frame
Baseline and until progression4
Genomic biomarkers in ctDNA
We will determine whether homologous recombination deficiency (HRD) assessment in ctDNA correlates with a favorable therapy response. We will perform deep whole genome sequencing (WGS) of ctDNA to determine the clonal evolution of prostate cancer during Radium-223 therapy.
Time frame
Before treatment, cycle 3 and 5 and with progressionSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Netherlands Cancer Institute
Lead sponsor
Bayer
Collaborator
Source ClinicalTrials.gov