AzTrials
AzTrials

mCRPCNCT06659926

The Radium-select Study

A study testing 68Ga-PSMA-PET/CT scan in people with mCRPC and Male Urogenital Diseases, run by The Netherlands Cancer Institute at 5 sites in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
mCRPC, Male Urogenital Diseases
What is being tested?
68Ga-PSMA-PET/CT scan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
5 sitesNetherlands
Study dates
24 Feb 2025to 1 Jul 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

J.C. van der Mijn, Dr. contact

+31205129111

k.vd.mijn@nki.nl

5 sites in 1 country

Netherlands5 sites, 5 recruiting

  • Meander Medisch Centrum

    Amersfoort, Utrecht, 3813TZ

    Joyce Dodewaard, MD, PhD, +31 (0)33-8501189, jm.van.dodewaard@meandermc.nl

    Recruiting

  • NKI-AVL

    Amsterdam, North Holland, 1066CX

    J.C. van der Mijn, MD, PhD, +31205129111, k.vd.mijn@nki.nl

    Koen van der Mijn, MD, PhD

    Recruiting

  • Sint Antonius ziekenhuis

    Nieuwegein, Utrecht, 3430EM

    Jules Lavalaye, MD, PhD, +31 883207500, j.lavalaye@antoniusziekenhuis.nl

    Recruiting

  • Diakonessenhuis

    Utrecht, 3582KE

    Tanja Oostergo, MD, MSc, +31 88 250 9810, toostergo@diakhuis.nl

    Not yet recruiting

  • UMC

    Utrecht, 3584CX

    Marnix Lam, MD, PhD, +31887555555, m.lam@umcutrecht.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: 68Ga-PSMA-PET/CT and Genomic Alterations for Future Selection of Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) for Radium-223 Treatment.

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.

Read the 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.

Being tested
68Ga-PSMA-PET/CT scan
Keywords
mCRPC, 68Ga-PSMA-PET/CT, Radium-223, Bone only-disease
Medical subject headings
Male Urogenital Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 68Ga-PSMA-PET/CT scanOther

    Also called Online patient reported outcome measure (PROM) questionnaires, Blood sampling

    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

Study groups in NCT06659926
Study groupRoleWhat they receive
mCRPC patients with bone-only disease according to 68Ga-PSMA-PET/CTOthera 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.
Receives: Other: 68Ga-PSMA-PET/CT scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 28 weeks

Secondary outcomes (4)

  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.

    Measured: In screening and cycle 2,3,4,5,6 (every 4 weeks) and with progression

  2. 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.

    Measured: 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).

    Measured: Baseline and until progression

  4. 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.

    Measured: Before treatment, cycle 3 and 5 and with progression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2024
  2. Study start24 Feb 2025
  3. Primary completion1 Jul 2029 (estimated)
  4. Study completion1 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06659926
Sponsor's protocol ID
M24PSM
Other IDs
NL86928.041.24
Status last verified
Jul 2025
First submitted
16 Aug 2024
Last updated
8 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 68Ga-PSMA-PET/CT scan in people with mCRPC and Male Urogenital Diseases, run by The Netherlands Cancer Institute at 5 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact J.C. van der Mijn, Dr. (+31205129111, k.vd.mijn@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical progression free survival (cPFS) (time frame: Up to 28 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06659926.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.

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