NCT07210086 Phase II Non-Randomized Study Evaluating POSLUMA-PSMA PET Response After Oligo- Metastatic/Progressive-directed Treatment With Radiotherapy (PROMPT-R)

Trial Parameters

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Brief Summary

This study aims to evaluate the role of PSMA-PET and circulating tumor DNA (ctDNA) in monitoring prostate cancer progression and response to radiotherapy (RT). Specifically, it investigates how often early progression is detected on PSMA-PET before PSA rise, examines PET responses of lesions treated with RT at 6 and 12 months and their correlation with PSA changes and later progression, examines ctDNA changes following ablative-intent RT to metastatic sites, and explores the relationship between PSMA-PET radiological findings and ctDNA dynamics.

Eligibility Criteria

Inclusion Criteria: * Documented informed consent of the participant or legally authorized representative. * Age: ≥ 18 years * KPS ≥ 70 or ECOG 0-1 (Appendix A) * Biopsy-confirmed diagnosis of castration-sensitive prostate adenocarcinoma, as defined by rising PSA in setting of T\>100 * Clinical diagnosis of de novo oligometastatic or oligoprogressive disease, as defined by one the following: De novo oligometastatic: newly diagnosed prostate cancer AND ≤ five metastatic sites outside of the pelvis (Metastatic sites may not be brain or liver.) OR Hormone Sensitive Oligoprogressive: history of prior local therapy for prostate cancer AND ≤ five progressing metastatic sites outside of the pelvis (Metastatic sites may not be brain or liver.) AND Hormone sensitive defined as clinical progression in absence of castration (T\>100) * Measurable disease by PERCIST v1.0 * Eligible to receive ablative-intent radiation therapy (biologically effective dose \[BED\] \>100, α/β ratio:2) directed to all

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