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PROMPT-R Study: PSMA PET Response After Radiotherapy for Prostate Cancer

This study, called PROMPT-R, is looking at how well a special scan called PSMA-PET (Positron Emission Tomography) can track prostate cancer progression and response to radiation treatment. It's for men with prostate cancer that has spread to a few spots (oligometastatic disease) or is progressing. Researchers want to see how often the PSMA-PET scan shows the cancer growing before a blood test (PSA) does. They will also look at how the cancer responds to radiation treatment on the PET scan at 6 and 12 months, and how this relates to PSA changes. Some participants will receive ADT (Androgen Deprivation Therapy) or ARSI (Androgen Receptor Signaling Inhibitor) in addition to radiation, while others who decline these will receive radiation alone. The study plans to enroll 50 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a non-randomized study, and the phase is not specified. It aims to enroll 50 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to measure early progressive disease on PSMA-PET prior to PSA progression.

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NCT07210086

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
City of Hope Medical Center
~50 participants
Updated 2026-01-28 on ClinicalTrials.gov
What's tested:ADTARSINo ADT/ARSI -decline

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Early PD on PSMA-PET prior to PSA-progression
Measured over Up to 5 years

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

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

Who to contact

Rose Li, MD, PhD
[email protected]
6263598111
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
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 sites of metastatic disease.
Primary site of disease (Prostate +/- Seminal Vesicles) is controlled or will receive ablative intent treatment as a part of this treatment course.
Baseline flotufolastat F18 PET imaging, if obtained as part of standard of care, is acceptable provided it was performed prior to the initiation of radiation therapy.
Agreement by females and males of childbearing potential\* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 30 days after the last dose of protocol therapy. \* Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only).
Any patient planning to receive lifelong continuous or intermittent ADT
For the current treatment course, patient must not have received more than 3 months of neoadjuvant ADT prior to consent.
Any contraindication to receiving flotufolastat F 18.
Diagnosis of polymetastatic (newly diagnosed prostate cancer and more than five metastatic sites outside of the pelvis or metastatic sites in brain or liver.)
Diagnosis of polyprogressive disease (History of metastatic prostate cancer with more than five progressive metastatic sites outside of the pelvis or metastatic sites in brain or liver).
Patients with a history or evidence of HIV infection (unless on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial).
Patients with history or evidence of chronic hepatitis B virus (HBV) infection (unless HBV viral load is undetectable on suppressive therapy).
Patients with a history or evidence of hepatitis C virus (HCV) infection (unless treated and cured. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load).
History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.
Any contraindications to undergo PSMA-PET.
Clinically significant uncontrolled illness.
Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).

What this trial measures

  • Early PD on PSMA-PET prior to PSA-progressionUp to 5 years

    Estimate percentage of patients whose PSMA\_PET shows progressing disease (either on new sites or previously irradiated sites) prior to PSA progression