RecruitingNot ApplicableNCT06659926

The Radium-select Study

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

Sponsor

The Netherlands Cancer Institute

Enrollment

60 participants

Start Date

Feb 24, 2025

Study Type

INTERVENTIONAL

Conditions

Male Urogenital Diseases mCRPC

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests radium-223 — a radioactive drug that targets bone metastases — in men with prostate cancer that has spread to the bones and is no longer responding to standard hormone treatments. Researchers will select patients most likely to benefit using advanced imaging. **You may be eligible if...** - You have confirmed prostate cancer that has spread to at least two bones (shown on bone scan) - Your PSA levels are rising or your cancer is progressing despite previous treatment - Your hemoglobin and platelet counts are within acceptable limits - You are receiving bone-protective medications and hormone therapy **You may NOT be eligible if...** - Your general health and function are significantly impaired (ECOG score above 2) - Your life expectancy is less than 6 months - Your cancer has spread to organs other than bones, or to large lymph nodes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHER68Ga-PSMA-PET/CT scan

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