Prostate-Specific Membrane Antigen (PSMA) PET Scans in People Prostate Cancer (NCT04030338) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Prostate-Specific Membrane Antigen (PSMA) PET Scans in People Prostate Cancer
United States58 participantsStarted 2019-07-19
Plain-language summary
The purpose of this study is to determine if Prostate-Specific Membrane Antigen (PSMA) positron emission tomography (PET) scans used in this study accurate and better at imaging participants' prostate cancer than the usual methods.
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:
* Patients with histologically confirmed prostate cancer, that is either: newly diagnosed OR progressive as defined by standard PCWG3 criteria. note that metastatic disease is defined by either bone scintigraphy or by CT or MRI, or a combination of these tests, but not exclusively by molecular imaging criteria.
Patients with newly diagnosed localized or metastatic prostate cancer are eligible, provided standard imaging (either bone scintigraphy, CT or MRI) demonstrates evidence of radiographic disease
Patient with progressive disease that is non-metastatic are eligible by biochemical progression: A minimum of three rising PSA values from a baseline that are obtained 1 week or more apart, or 2 measurements 2 or more weeks apart
Patients with progressive disease that is metastatic are eligible either by biochemical progression or radiographic progression or both
Patients are permitted to have had up to 2 months of prior hormonal therapy before entering this trial (and many therapeutic trials) and therefore, their progression criteria would apply to their pre-treatment imaging and PSA parameters Note: This criterion pertains to patients with newly diagnosed, untreated disease. This criterion does not apply to those who were already on therapy for metastatic CRPC.
* Karnofsky performance status of \>/= 50 (or ECOG/WHO equivalent)
* Male (or transgender female) \> 18 years of age
* Patient must be able to understand and willing to sign a written informed …
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.
1This trial is testing whether PSMA PET scans can predict things like cancer spread and survival time — does my current situation, such as whether my PSA is rising or whether I already have metastases, make me a good candidate to discuss this type of imaging?
2Since this trial is no longer actively enrolling, are there similar or follow-up studies using PSMA PET scans that I might still be able to participate in, or can I access this type of scan outside of a trial?
3The trial is measuring how well changes on PSMA PET scans predict biochemical progression and metastasis — would having this kind of imaging now give my care team more useful information about how to monitor or adjust my treatment plan?
4Since this is a diagnostic imaging study rather than a treatment trial, what are the actual risks involved in undergoing a PSMA PET scan, and is the radioactive tracer used considered safe?
5If PSMA PET imaging shows early signs that my cancer might be spreading, how would that realistically change the treatment decisions you'd make for me compared to standard monitoring approaches?
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.
What they're measuring
1
Measure predictive accuracy of the change in PSMA PET with respect to the time to biochemical progression
Timeframe: start of treatment to the first PSA level above 0.2 ng/ml, up to 100 months
2
Measure predictive accuracy of the change in PSMA PET with respect to the time to metastasis
Timeframe: Time from the start of treatment to evidence of systemic disease on bone scan or CT/MRI, up to 100 months
3
Measure predictive accuracy of the change in PSMA PET with respect to overall survival time.
Timeframe: Time from the start of treatment to date of death from any cause, assessed up to up to 100 months