RecruitingPhase 2NCT07210086

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


Sponsor

City of Hope Medical Center

Enrollment

50 participants

Start Date

Nov 26, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (PROMPT-R) uses a PSMA PET scan (a highly sensitive imaging test for prostate cancer) to evaluate how well targeted radiation to a small number of cancer sites (oligometastatic disease) works in men with hormone-sensitive prostate cancer. **You may be eligible if...** - You are 18 or older with good overall health (KPS ≥ 70 or ECOG 0–1) - You have castration-sensitive prostate cancer (responding to hormone levels) - You have 5 or fewer metastatic sites outside the pelvis (not in brain or liver) - Your cancer has been confirmed by biopsy as prostate adenocarcinoma - Your PSA is rising and testosterone is above 100 ng/dL **You may NOT be eligible if...** - You have more than 5 metastatic sites - Your cancer has spread to the brain or liver - Your cancer has become resistant to hormone therapy (castration-resistant) - You do not meet health and performance requirements 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

DRUGADT

Androgen Deprivation Therapy

DRUGARSI

Androgen Receptor Signaling Inhibitor

OTHERNo ADT/ARSI -decline

Recurrent prostate cancer with oligometastatic disease who decline ADT/ARSI and are treated with ablative intent RT alone and who have \<=5 extrapelvic lesions detected on a baseline PSMA-PET and have rising PSA.


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT07210086


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