68Ga-PSMA-11 PET for the Diagnosis of Metastatic Castration Resistant Prostate Cancer (NCT04716725) | Clinical Trial Compass
TerminatedPhase 2
68Ga-PSMA-11 PET for the Diagnosis of Metastatic Castration Resistant Prostate Cancer
Stopped: Low accrual
United States15 participantsStarted 2021-09-28
Plain-language summary
This phase II trial studies the use of 68Ga-PSMA-11 positron emission tomography (PET) in diagnosing patients with prostate cancer that continues to grow despite the surgical removal of the testes or medical intervention to block androgen production (castration resistant), and has spread to other places in the body (metastatic). 68Ga- PSMA-11 is a new imaging agent that may help get more detailed pictures of the tumor. This trial aims to see whether using 68Ga-PSMA-11 PET scans may help doctors learn more about where disease is located in the body.
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
. Sub-cohort A1: Patients must have baseline evaluations performed within 12 weeks prior to the start of systemic therapy.
. Sub-cohort A2: Patients must meet all the following requirements:
. Patients must have progressive castration resistant prostate cancer, according to PCWG3 criteria.
. Patients must have planned initiation of systemic treatment (sub-cohort A1), or ongoing systemic treatment (sub-cohort A2) for castration resistant prostate cancer within 12 weeks of baseline Ga-PSMA PET.
. Patients must have at least one metastatic lesion with PSMA uptake at or above the blood pool on their baseline PSMA PET scan.
. The patient must be able and willing to comply with study procedures and provide signed and dated informed consent.
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.
What they're measuring
1
Mean Maximum Standard Uptake Value (SUVmax)
Timeframe: Baseline, and up to 16 weeks after initiation of therapy
2
Median SUVmax
Timeframe: Baseline, and up to 16 weeks after initiation of therapy
3
Percentage of Participants Who Progressed by Prostate-specific Antigen (PSA) Response Group
Timeframe: Baseline, and up to 16 weeks after initiation of therapy
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
. Patient must be Aged 18 years or older at the time of study entry.
Exclusion criteria
. Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
. Patients with any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures.
. Patients with any contra-indication to magnetic resonance imaging (MRI) (e.g. pacemaker placement, severe claustrophobia) Note: The exclusion criteria above (3) is only applicable for patients scheduled for a Positron Emission Tomography (PET) MRI (PET/MRI).