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NCT Number: NCT06659926

The Radium-select Study

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.

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Key information

Conditions

MCRPC Male Urogenital Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

NKI-AVL, Amsterdam, North Holland, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Other names: Online patient reported outcome measure (PROM) questionnaires, Blood sampling

Primary outcomes

  1. Clinical progression free survival (cPFS)

    Time frame: Up to 28 weeks

    The primary study endpoint will be clinical progression free survival (cPFS) in 30 patients with bone-only disease according to PSMA PET/CT.

Secondary outcomes

  1. Patient reported outcome measures ( PROMs).

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

    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.

  2. Overall survival (OS)

    Time frame: In Follow up (q6months, max 24 months)

    OS will be defined as time from first Radium-223 treatment to the date of death, or censored at last follow-up.

  3. Baseline and changes in 68 Ga-PSMA-PET-CT parameters

    Time frame: Baseline and until progression

    Baseline and changes in 68Ga-PSMA-PET/CT parameters (disease localizations, extent of disease, tumor volume).

  4. Genomic biomarkers in ctDNA

    Time frame: Before treatment, cycle 3 and 5 and with progression

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

J.C. van der Mijn, Dr.

CONTACT

[email protected]

+31205129111

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Collaborators

  • Bayer

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Oct 26, 2024
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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