Phase II Non-Randomized Study Evaluating POSLUMA-PSMA PET Response After Oligo- Metastatic/Progressive-directed Treatment With Radiotherapy (PROMPT-R)
City of Hope Medical Center
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.
Description
Primary Objective: \* Identify the frequency of early progressive disease on PSMA-PET prior to PSA progression. Secondary Objectives: * Describe the PET response to lesions given RT at 6 months (and 12 month if applicable), and its relationship to PSA changes, and to later progressive disease both on PET and with PSA progression for each cohort * Characterize the changes in ctDNA levels after ablative-intent RT to metastatic sites. * Describe the radiological changes from PSMA-PET and its relationship with ctDNA.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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…
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.
Location
- City of Hope Medical CenterDuarte, California