Phase II Non-Randomized Study Evaluating POSLUMA-PSMA PET Response After Oligo- Metastatic/Progressive-directed Treatment With Radiotherapy (PROMPT-R)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether PSMA-PET scans and blood tests for tumor DNA can help track prostate cancer after radiation treatment. It looks at whether scans find cancer growth before PSA, a blood marker, rises. It is for adults with prostate cancer that is still hormone-sensitive and has spread or is growing in only a few places.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older and give informed consent, yourself or through a legal representative.
- Be able to care for yourself and do most daily activities, based on the study’s activity score.
- Have prostate adenocarcinoma confirmed by a tissue sample. The cancer must still be hormone-sensitive, with rising PSA and a testosterone level above 100.
- Have newly diagnosed cancer with no more than 5 spread sites outside the pelvis, or previously treated prostate cancer with no more than 5 growing spread sites outside the pelvis. There must be no spread to the brain or liver.
- Have cancer that can be measured using the study’s scan rules.
- Be able to receive radiation aimed at destroying cancer at all spread sites. Cancer in the prostate and nearby seminal vesicles must be controlled or treated during this treatment course.
- If a routine-care flotufolastat F18 PET scan is used as the starting scan, it must have been done before radiation began.
- If able to have children, agree to use effective birth control or avoid sex that could cause pregnancy during the study and for at least 30 days after the last study treatment.
Who can't join
- Plan to receive lifelong hormone-lowering treatment, called ADT, either continuously or with breaks; or have received more than 3 months of ADT before consent for the current treatment course.
- Have more than 5 spread sites outside the pelvis with newly diagnosed cancer, more than 5 growing spread sites outside the pelvis with previously metastatic cancer, or any spread to the brain or liver.
- Cannot safely have a PSMA-PET scan or receive its imaging drug, flotufolastat F18, or have had an allergic reaction to a similar substance.
- Have HIV unless on effective treatment with no virus detected in the blood within the past 6 months.
- Have chronic hepatitis B unless treatment keeps the virus undetectable in the blood. Have hepatitis C unless treated and cured, or currently on treatment with no virus detected.
- Have a serious illness that is not controlled, or another condition that the study doctor believes makes participation unsafe.
- Have another active cancer, unless its course or treatment would not interfere with judging this study’s safety or effectiveness.
- The study doctor believes you may not be able to follow all study procedures, including because of travel or scheduling problems.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 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) * 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). Exclusion CriteriPrior and concomitant therapies * 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).
Study sites (1)
CA
- City of Hope Medical Center · Duarte, CA 91010Rose Li, MD, PhD · Study contact · 626-359-8111 · yunroseli@coh.orgMore trials in Duarte