PSMA PET/CT for Assessment of Recurrent Prostate Cancer
-
- STATUS
- Recruiting
-
- End date
- Dec 25, 2025
-
- participants needed
- 1574
-
- sponsor
- British Columbia Cancer Agency
Summary
Prostate cancer (PC) is the third most common cause of cancer death in men. Most patients with localized PC will be cured with surgery or radiation therapy, but up to 35% of patients will have their PC return. Whether it has returned locally or distantly determines which type of treatment they will receive. Current conventional imaging modalities have limitations particularly at low prostate-specific antigen (PSA) levels. This study proposes to use Fluorine-18-2-(3-(1-carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl)-ureido)-pen tanedioic acid (18F-DCFPyL) Positron Emission Tomography / Computer Tomography (PET/CT) scans which targets prostate-specific membrane antigens (PSMA) to detect where in the body the PC has recurred.
Description
This is a prospective single cohort study to evaluate the diagnostic utility of 18F-DCFPyL PET/CT in detecting sites of recurrent prostate cancer, in patients who have negative or equivocal findings on conventional imaging. Eligible subjects will undergo a 18F-DCFPyL PET/CT at the British Columbia Cancer Agency (BCCA) - Vancouver Centre.
18F-DCFPyL- Each subject will receive an 18F-DCFPyL PET/CT scan at the BCCA - Vancouver Centre, as part of this research study. Each study subject will receive a bolus intravenous dose of 18F-DCFPyL. The subject will rest in a comfortable chair for 120 minutes and will then be taken to the PET/CT scanner for images. The PET/CT scan will take approximately three hours extra of patient time above and beyond the time needed for standard of care.
Medical History Questionnaire- Demographic and medical history data will be collected either in person before the PET scan appointment or by mail or phone, whichever is the most convenient to the subject.
Follow-up assessments- Positive 18F-DCFPyL findings should be investigated and correlated with other imaging modalities and/or biopsy whenever possible. These additional procedures are left at the discretion of the referring physician for the clinical management of their patient, and will not be mandated by the study. The results of such investigations will be captured during the follow-up period, to verify the accuracy of 18F-DCFPyL findings.
All subjects will be requested to either return to the functional imaging department approximately 24 hours (acceptable range 16-28 hours) after the injection of 18F-DCFPyL or agree to be contacted by phone. The subjects will be asked if they experienced any undesirable effects following the administration of 18F-DCFPyL, or in the intervening 24 hours. The local site attending nuclear medicine physician will then make an assessment as to whether these effects are likely related to 18F-DCFPyL administration.
All subjects will receive up to three clinical follow-up evaluations at 12, 24 and 36 months following the 18F-DCFPyL PET/CT exam to assess the presence of recurrence, once presence of recurrence is confirmed follow-up will be discontinued. The evaluation will include a chart review of available imaging, laboratory tests, and treatment along with review of any symptoms. The data required can be obtained from a review of the patient's paper and electronic charts, supplemented by telephone contact as needed to complete the information. The treating oncologist will fill out a survey to determine the clinical impact of the 18F-DCFPyL on clinical managements. This will be categorized into 'minor' (change in treatment site or dose) or 'major' (change in treatment modality).
Details
| Condition | Prostatic Neoplasms, Prostate Cancer |
|---|---|
| Treatment | PSMA PET/CT scan |
| Clinical Study Identifier | NCT02899312 |
| Sponsor | British Columbia Cancer Agency |
| Last Modified on | 25 February 2022 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer