Actively Recruiting
Phase II Non-Randomized Study Evaluating POSLUMA-PSMA PET Response After Oligo- Metastatic/Progressive-directed Treatment With Radiotherapy (PROMPT-R)
Led by City of Hope Medical Center · Updated on 2026-01-28
50
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Phase II Non-Randomized Study Evaluating POSLUMA-PSMA PET Response After Oligo- Metastatic/Progressive-directed Treatment With Radiotherapy (PROMPT-R)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or legally authorized representative provides documented informed consent.
- Age is 18 years or older.
- Karnofsky Performance Status (KPS) of 70 or higher or ECOG performance status 0-1.
- Biopsy-confirmed diagnosis of castration-sensitive prostate adenocarcinoma with rising PSA and testosterone greater than 100.
- Clinical diagnosis of de novo oligometastatic disease with five or fewer metastatic sites outside the pelvis (excluding brain and liver), or hormone-sensitive oligoprogressive disease with five or fewer progressing metastatic sites outside the pelvis (excluding brain and liver) and clinical progression without castration.
- Measurable disease as defined by PERCIST v1.0 criteria.
- Eligible to receive ablative-intent radiation therapy with biologically effective dose over 100 directed to all metastatic sites.
- Primary prostate disease (prostate and/or seminal vesicles) is controlled or will be treated with ablative intent during the study.
- Baseline flotufolastat F18 PET imaging performed prior to radiation therapy is acceptable.
- Agreement by males and females of childbearing potential to use effective birth control or abstain from heterosexual activity during the study and for at least 30 days after the last protocol therapy dose.
You will not qualify if you...
- Planned lifelong continuous or intermittent androgen deprivation therapy (ADT).
- Received more than 3 months of neoadjuvant ADT before consent for the current treatment course.
- Contraindications to receiving flotufolastat F18.
- Diagnosis of polymetastatic disease with more than five metastatic sites outside the pelvis or metastases in brain or liver.
- Diagnosis of polyprogressive disease with more than five progressive metastatic sites outside the pelvis or metastases in brain or liver.
- History or evidence of HIV infection, unless on effective therapy with undetectable viral load within 6 months.
- History or evidence of chronic hepatitis B infection unless on suppressive therapy with undetectable viral load.
- History or evidence of hepatitis C infection unless treated and cured; patients on treatment with undetectable viral load are eligible.
- History of allergic reactions to compounds similar to the study agents.
- Contraindications to undergoing PSMA-PET imaging.
- Clinically significant uncontrolled illness.
- Other active malignancies that could interfere with safety or study assessments.
- Any condition judged by the investigator to contraindicate participation due to safety or study procedure concerns.
- Inability to comply with all study procedures or logistical feasibility concerns as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
Research Team
R
Rose Li, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here