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

NCT07210086 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-01-28

No results posted yet for this study

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.

Conditions

Interventions

OTHER

No 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.

DRUG

ADT

Androgen Deprivation Therapy

DRUG

ARSI

Androgen Receptor Signaling Inhibitor

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Rose Li, MD, PhD · City of Hope Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-26
Primary Completion
2028-05-13
Completion
2028-05-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07210086 on ClinicalTrials.gov