Trial Title:
The Radium-select Study
NCT ID:
NCT06659926
Condition:
mCRPC
Male Urogenital Diseases
Conditions: Official terms:
Urogenital Diseases
Male Urogenital Diseases
Gallium 68 PSMA-11
Conditions: Keywords:
mCRPC
68Ga-PSMA-PET/CT
Radium-223
Bone only-disease
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
The investigators will conduct a prospective clinical study in which patients with mCRPC
and bone-only disease according to ceCT and bone scan will receive standard-of-care
treatment with Radium-223. In addition to standard-of-care systemic treatment, each
patient will undergo an additional 68Ga-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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
The treating physicians will be blinded to the result of the baseline 68Ga-PSMA-PET/CT
scan
Intervention:
Intervention type:
Other
Intervention name:
68Ga-PSMA-PET/CT scan
Description:
68Ga-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
Arm group label:
mCRPC patients with bone-only disease according to 68Ga-PSMA-PET/CT
Other name:
Online patient reported outcome measure (PROM) questionnaires
Other name:
Blood sampling
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.
Detailed description:
Study design:
The investigators will conduct a prospective clinical study in which patients with mCRPC
and bone-only disease according to ceCT and bone scan will receive standard-of-care
treatment with Radium-223. In addition to standard-of-care systemic treatment, each
patient will undergo an additional 68Ga-PSMA-PET/CT scan at baseline and will be followed
throughout the treatment with patient reported outcome measure (PROM) questionnaires
(Kaiku application) and blood sampling for circulating tumor DNA (ctDNA) analysis. The
treating physicians will be blinded to the result of the baseline 68Ga-PSMA-PET/CT scan.
Each patient will receive a maximum number of 6 cycles of Radium-223 therapy according to
current clinical guidelines and will undergo response evaluation by ceCT and bone scans
upon clinical progression. 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. The clinical response of Radium-223
therapy in the patients with bone-only disease according to 68Ga-PSMA-PET/CT scanning,
will be compared to the treatment outcomes collected in our previously reported ROTOR
registry. Secondary aims are to determine the value of ctDNA as predictive biomarker and
the value of 68Ga-PSMA-PET/CT imaging in the response assessment.
Criteria for 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)
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
NKI-AVL
Address:
City:
Amsterdam
Zip:
1066CX
Country:
Netherlands
Contact:
Last name:
J.C. van der Mijn, MD, PhD
Phone:
+31205129111
Email:
k.vd.mijn@nki.nl
Investigator:
Last name:
Koen van der Mijn, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Meander Medisch Centrum
Address:
City:
Amersfoort
Zip:
3813TZ
Country:
Netherlands
Contact:
Last name:
Joyce Dodewaard, MD, PhD
Phone:
+31 (0)33-8501189
Email:
jm.van.dodewaard@meandermc.nl
Facility:
Name:
Sint Antonius ziekenhuis
Address:
City:
Nieuwegein
Zip:
3430EM
Country:
Netherlands
Contact:
Last name:
Jules Lavalaye, MD, PhD
Phone:
+31 883207500
Email:
j.lavalaye@antoniusziekenhuis.nl
Facility:
Name:
Diakonessenhuis
Address:
City:
Utrecht
Zip:
3582KE
Country:
Netherlands
Contact:
Last name:
Tanja Oostergo, MD, MSc
Phone:
+31 88 250 9810
Email:
toostergo@diakhuis.nl
Facility:
Name:
UMC
Address:
City:
Utrecht
Zip:
3584CX
Country:
Netherlands
Contact:
Last name:
Marnix Lam, MD, PhD
Phone:
+31887555555
Email:
m.lam@umcutrecht.nl
Start date:
December 1, 2024
Completion date:
July 1, 2029
Lead sponsor:
Agency:
The Netherlands Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Bayer
Agency class:
Industry
Source:
The Netherlands Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06659926
