The Radium-select Study

NCT06659926 | Recruiting

• 2 other identifiers: M24PSMNL86928.041.24
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

mCRPC; Male Urogenital Diseases

Keywords

mCRPC; 68Ga-PSMA-PET/CT; Radium-223; Bone only-disease

Outcome Measures

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.

  Up to 28 weeks

Secondary Outcomes (4)

• Patient reported outcome measures ( PROMs).

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

• Overall survival (OS)

  In Follow up (q6months, max 24 months)

• Baseline and changes in 68 Ga-PSMA-PET-CT parameters

  Baseline and until progression

• Genomic biomarkers in ctDNA

  Before treatment, cycle 3 and 5 and with progression

Study Arms (1)

mCRPC patients with bone-only disease according to 68Ga-PSMA-PET/CT

OTHER

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.

Other: 68Ga-PSMA-PET/CT scan

Interventions

68Ga-PSMA-PET/CT scan OTHER

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

Also known as: Online patient reported outcome measure (PROM) questionnaires, Blood sampling

mCRPC patients with bone-only disease according to 68Ga-PSMA-PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• Bayer: collaborator

Study Sites (5)

NKI-AVL

Amsterdam, North Holland, 1066CX, Netherlands

RECRUITING

Meander Medisch Centrum

Amersfoort, Utrecht, 3813TZ, Netherlands

RECRUITING

Sint Antonius ziekenhuis

Nieuwegein, Utrecht, 3430EM, Netherlands

RECRUITING

Diakonessenhuis

Utrecht, 3582KE, Netherlands

NOT YET RECRUITING

UMC

Utrecht, 3584CX, Netherlands

RECRUITING

MeSH Terms

Conditions

Male Urogenital Diseases

Interventions

Surveys and Questionnaires; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Officials

• J.C. van der Mijn

  NKI-AvL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

J.C. van der Mijn, Dr.

CONTACT

+31205129111; k.vd.mijn@nki.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The treating physicians will be blinded to the result of the baseline 68Ga-PSMA-PET/CT scan
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: October 26, 2024
• Study Start: February 24, 2025
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (5)