PSMA-PET/CT and genomic alterations for future selection of patients with metastatic castration resistant prostate cancer (mCRPC) for Radium-223 treatment.

PSMA-PET/CT and genomic alterations for future selection of patients with metastatic castration resistant prostate cancer (mCRPC) for Radium-223 treatment. - The Radium-select study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57275

Enrollment

Registered

2024-07-09

Start date

2025-03-12

Completion date

Unknown

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate carcinoma Prostate cancer

Interventions

Intervention:PSMA-PET/CT (2x)PROM questionnaire (3x): FACT-P, BPI-S, questionnaire use of pain relief (7x)Plasma: ctDNA sampling (4x)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed adenocarcinoma of the prostate. 2) Progressive disease after previous treatment defined as a rise in serum PSA (PCWG3 criteria(22), see appendix 1) and/or progression on conventional imaging (PCWG3). 3) A positive bone scan (osteoblastic bone metastases), with at least two metastases. 4) Hemoglobin concentration >10 g/dl (6.2 mmol/l) and thrombocytes >100 109/l at baseline. 5) 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

Exclusion criteria: 1) ECOG performance score >2  2) Life expectancy < 6 months. 3) Detected extra-skeletal metastases or lymph node metastases (>3 cm short  axis) as identified by conventional imaging (ceCT thorax/abdomen)

Design outcomes

Primary

Measure	Time frame
Clinical progression free survival (cPFS). cPFS will be defined as the time from first Radium-223 treatment to the date of confirmed progression: clinical progression (WHO PS * 3, new prostate cancer symptoms, skeletal related events, a persisting rise in both PSA and ALP) or radiographic progression based on ceCT or bone scan; start of subsequent treatment (including External Beam Radiotherapy: EBRT and radionuclide therapy to treat generalized pain); death or censored at last follow-up. Whichever comes first. Routine interim imaging in patients that do not show clinical signs of disease progression will not be permitted.	—

Measure

Time frame

Clinical progression free survival (cPFS). cPFS will be defined as the time from first Radium-223 treatment to the date of confirmed progression: clinical progression (WHO PS * 3, new prostate cancer symptoms, skeletal related events, a persisting rise in both PSA and ALP) or radiographic progression based on ceCT or bone scan; start of subsequent treatment (including External Beam Radiotherapy: EBRT and radionuclide therapy to treat generalized pain); death or censored at last follow-up. Whichever comes first. Routine interim imaging in patients that do not show clinical signs of disease progression will not be permitted.

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Secondary

Measure	Time frame
• Patient reported outcome measures (PROMs). Each participant will be asked to complete questionnaires on health related quality of life (HRQoL), including the FACT-P, pain (BPI-SF) and analgesics use after every treatment cycle. • 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. • PSMA-PET/CT parameters will be assessed at end of treatment. PSMA-PET/CT will be used to evaluate whether clinical progression was driven by bone lesions or (new) extraskeletal lesions. • 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 before and after treatment to determine the clonal evolution of prostate cancer during Radium-223 therapy.	—

Measure

Time frame

• Patient reported outcome measures (PROMs). Each participant will be asked to complete questionnaires on health related quality of life (HRQoL), including the FACT-P, pain (BPI-SF) and analgesics use after every treatment cycle. • 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. • PSMA-PET/CT parameters will be assessed at end of treatment. PSMA-PET/CT will be used to evaluate whether clinical progression was driven by bone lesions or (new) extraskeletal lesions. • 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 before and after treatment to determine the clonal evolution of prostate cancer during Radium-223 therapy.

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Countries

Netherlands

Contacts

Public ContactH.A. Schrijver

Antoni van Leeuwenhoek (AVL)

h.schrijver@nki.nl0205129111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 3, 2026