This Study Evaluates the Diagnostic Performance and Safety of 68Ga-NYM032 PET/CT Imaging in Patie… (NCT07649122) | Clinical Trial Compass
Not Yet RecruitingPhase 3
This Study Evaluates the Diagnostic Performance and Safety of 68Ga-NYM032 PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer.
232 participantsStarted 2026-06-30
Plain-language summary
This study evaluates the diagnostic performance and safety of 68Ga-NYM032 PET/CT imaging in patients with suspected recurrence of prostate cancer.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient is male and aged \>18 years old.
. Participants with histopathologically confirmed prostate adenocarcinoma, who present with elevated PSA and suspected recurrence following radical prostatectomy and/or radiotherapy and/or other radical prostate cancer treatments (e.g., proton therapy, cryoablation, high-intensity focused ultrasound, etc.). (PSA must be measured within 30 days prior to screening.). (Meeting any one of the following criteria):
. Post-radical prostatectomy (RP): PSA ≥0.2 ng/mL on two consecutive measurements obtained ≥6 weeks after surgery;
. Post-radiotherapy (as defined by the ASTRO-Phoenix consensus): PSA rise ≥2 ng/mL above the PSA nadir;
. Participants with recurrence after other treatments: PSA rise ≥2 ng/mL above the PSA nadir.
. ECOG performance status 0-2; expected survival ≥ 6 months.
. Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion criteria
. Participants who have previously participated in other interventional clinical trials and are within five physical half-lives, or have received radionuclide agents previously with an interval of less than ten physical half-lives prior to study drug injection.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Participants administered any IV iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days, prior to study drug injection.
. Known hypersensitivity to the active ingredient or excipients of the study drug.
. Participants not capable of getting PET study , or inability to lay still for the duration of the exam.
. Any medical condition or circumstance that, in the investigator's judgment, may compromise study safety or patient compliance.