Prostate CancerPhase 2NCT07210086
Phase II Non-Randomized Study Evaluating POSLUMA-PSMA PET Response After Oligo- Metastatic/Progressive-directed Treatment With Radiotherapy (PROMPT-R)
A Phase 2 study testing ADT, ARSI and No ADT/ARSI -decline in people with Prostate Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ADT, ARSI and No ADT/ARSI -decline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2025to 13 May 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 prior local therapy for prostate cancer AND ≤ five progressing metastatic sites outside of the pelvis (Metastatic sites may not be brain or liver.) AND Hormone sensitive defined as clinical progression in absence of castration (T>100)
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- 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).
Who cannot join
- 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).
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Rose Li, MD, PhD, 626-359-8111, yunroseli@coh.org
About this study
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.
Read the detailed 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.
- Conditions
- Prostate Cancer
- Being tested
- ADT, ARSI, No ADT/ARSI -decline
- Keywords
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADTDrug
Androgen Deprivation Therapy
ARSIDrug
Androgen Receptor Signaling Inhibitor
No ADT/ARSI -declineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| De novo oligometastatic disease treated with ADT+ARSI+ablative intent RT | Other | De novo oligometastatic disease treated with ADT+ARSI+ablative intent RT and who have <=5 extrapelvic lesions detected on a baseline PSMA-PET and have rising PSA. Receives: Drug: ADT; Drug: ARSI |
| Recurrent disease with oligometastatic disease treated with ADT+ablative intent RT | Other | Recurrent disease with oligometastatic disease treated with ADT+ablative intent RT and who have <=5 extrapelvic lesions detected on a baseline PSMA-PET and have rising PSA. Receives: Drug: ADT |
| Recurrent prostate ca with oligometastatic disease who decline ADT/ARSI | Other | 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. Receives: Other: No ADT/ARSI -decline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early PD on PSMA-PET prior to PSA-progression
Estimate percentage of patients whose PSMA_PET shows progressing disease (either on new sites or previously irradiated sites) prior to PSA progression
Measured: Up to 5 years
Secondary outcomes (2)
Describe the PET response to lesions and its relationship to PSA changes
Describe the PET response to lesions given RT at 6 months (and 12 months if applicable), and its relationship to PSA changes, and to later PD both on PET and with PSA progression for each cohort.
Measured: Up to 5 years.
Characterize the changes in ctDNA levels
Characterize the changes in ctDNA levels after ablative-intent RT to metastatic sites and its relationship to PSMA-PET changes.
Measured: Up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start26 Nov 2025
- Primary completion13 May 2030 (estimated)
- Study completion13 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Rose Li, MD, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210086
- Sponsor's protocol ID
- 25339
- Other IDs
- P30CA033572, NCI-2025-07236, 25339
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Non-Randomized Study Evaluating POSLUMA-PSMA PET Response After Oligo- Metastatic/Progressive-directed Treatment With Radiotherapy (PROMPT-R)
- ClinicalTrials.gov ID
- NCT07210086
- Acronym / sponsor ID
- 25339
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- 13 May 2030 (estimated)
- Study completion
- 13 May 2030 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| De novo oligometastatic disease treated with ADT+ARSI+ablative intent RT | Other | Drug: ADT, Drug: ARSIDe novo oligometastatic disease treated with ADT+ARSI+ablative intent RT and who have <=5 extrapelvic lesions detected on a baseline PSMA-PET and have rising PSA. |
| Recurrent disease with oligometastatic disease treated with ADT+ablative intent RT | Other | Drug: ADTRecurrent disease with oligometastatic disease treated with ADT+ablative intent RT and who have <=5 extrapelvic lesions detected on a baseline PSMA-PET and have rising PSA. |
| Recurrent prostate ca with oligometastatic disease who decline ADT/ARSI | Other | Other: No ADT/ARSI -declineRecurrent 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADTAndrogen Deprivation Therapy | Drug | De novo oligometastatic disease treated with ADT+ARSI+ablative intent RT, Recurrent disease with oligometastatic disease treated with ADT+ablative intent RT |
| ARSIAndrogen Receptor Signaling Inhibitor | Drug | De novo oligometastatic disease treated with ADT+ARSI+ablative intent RT |
| No ADT/ARSI -declineRecurrent 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. | Other | Recurrent prostate ca with oligometastatic disease who decline ADT/ARSI |
Primary outcome
Early PD on PSMA-PET prior to PSA-progression
Time frame: Up 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
2 secondary outcomes
Describe the PET response to lesions and its relationship to PSA changes
Time frame: Up to 5 years.
Characterize the changes in ctDNA levels
Time frame: Up to 5 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rose Li, MD, PhD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADT, ARSI and No ADT/ARSI -decline in people with Prostate Cancer, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rose Li, MD, PhD (6263598111, yunroseli@coh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early PD on PSMA-PET prior to PSA-progression (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.