Detecting Metastases by PyL PET/CT in Subjects Starting Enzalutamide for Untreated Castration Res… (NCT04655365) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Detecting Metastases by PyL PET/CT in Subjects Starting Enzalutamide for Untreated Castration Resistant Prostate Cancer.
Canada50 participantsStarted 2022-03-22
Plain-language summary
This study aimed to evaluate the diagnostic performance of 18F-DCFPyL (PyL) PET/CT in subjects presenting not previously treated for castration resistant prostate cancer and showing negative or equivocal findings per institutional standard of care conventional imaging
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:
* Histologically confirmed adenocarcinoma of the prostate per original diagnosis, with undergoing androgen deprivation therapy such as prior bilateral orchiectomy or surgical castration or LHRH-agonists/LHRH-antagonists.
* Suspected recurrence of prostate cancer based on rising PSA under androgen deprivation therapy. Recurrent castration resistant prostate cancer patients are defined by a rising PSA \>1 ng/mL under ADT or surgical castration and with testosterone castration levels \< 1.7 nM (PCWG3 criteria).
* Negative, equivocal findings or oligometastatic disease (\< 5) for prostate cancer on conventional imaging bone scan AND 2) abdomen-pelvis CT/MRI and chest CT or FDG-PET/CT or 18F-NaF PET/CT performed as standard of care workup within 90 days of signing the ICF.
* The subject is candidate for second line androgen axis targeted inhibitors such as enzalutamide and planned to receive it.
* Life expectancy ≥6 months as determined by the investigator
* Able and willing to provide signed informed consent and comply with protocol requirement
* PSA doubling time less or equal to 10 months
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.
* Able to swallow the study drug and comply with study requirements.
Exclusion Criteria:
* Subjects administered any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to study drug injection.
* Receipt of investigational drug therapy for prostate ca…
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
Determine the percentage of patients presenting new metastatic lesions detected by 18F-DCFPyL-PSMA PET/CT in castration resistant prostate cancer patients presenting non metastatic, equivocal or oligometastatic (< 5 metastasis) disease
Timeframe: Through study completion, an average of 1 year
2
Determine the number of discordant lesions between conventional and PSMA-PET/CT imaging in castration resistant prostate cancer patients presenting with non metastatic, equivocal or oligometastatic (< 5 metastasis) disease defined by conventional imagi
Timeframe: through study completion, an average of 1 year
3
Determine the percentage of patients showing 18F-DCFPyL-PSMA PET/CT active lesions at progression (V5) that were active on either baseline and 3-month PSMA-PET/CT (extension phase)
Timeframe: through study extension phase completion, an average of 1 year
4
In patients with 18F-DCFPyL-PSMA PET/CT active lesions at progression (V5), determine the percentage of lesions that were NOT active on either baseline and 3-month PSMA-PET/CT (New lesions) (extension phase)
Timeframe: through study extension phase completion, an average of 1 year