Carcinoma of ProstatePM-PPRNCT03535831
PSMA PET Registry (18F-DCFPyL)
A study testing 18F-DCFPyL in people with Carcinoma of Prostate, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of the Princess Margaret Cancer Centre PSMA registry is to assess the contribution of 18F-DCFPyL (PSMA) PET imaging (PET/MR or PET/CT) to the management of patients with prostate cancer (PCa). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Carcinoma of Prostate
- What is being tested?
- 18F-DCFPyL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteCanada
- Study dates
- 27 Apr 2018to 3 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients will be eligible for inclusion in this study if they meet all of the following criteria:
- Age ≥ 18 years
- Histologic diagnosis of carcinoma of prostate
- Being staged or restaged for any of the following indications:
- Staging of patients with:
- High risk disease; defined as at least one of the following: a. Gleason ≥8, b. ≥T3 disease, c. PSA >20 ng/ml; ii. Unfavourable intermediate-risk disease defined as: a. more than one intermediate-risk factor (cT2b/ cT2c; GS=7; serum PSA of 10-20 ng/ml); or b. Gleason score of 4+3=7 or more; or c. greater than 50% positive biopsy cores.
Show all 10Show fewer
- Staging or restaging of PCa with equivocal findings on conventional workup:
- Patients with PCa being staged or restaged with equivocal findings on conventional workup (CT, bone scan, MRI); to help guide management or select appropriate site for biopsy to establish disease status.
- Restaging of patients with:
- Biochemical failure (BCF) after primary therapy (radical prostatectomy or primary radiotherapy), or ii. BCF after salvage therapy/therapies when further treatment is being considered or iii. Pathologically involved nodes at time of radical prostatectomy or iv. Persistently detectable PSA (>0.1 ng/ml) >3 months after prostatectomy 5.1.4 Ability to provide written informed consent to participate in the study
Who cannot join
- Patients will be ineligible to participate in this study if they meet any of the following criteria:
- Inability to lie still for PET/CT or PET/MR examination
- For patients undergoing PET/MR only, any contraindication to MRI as per Joint Department of Medical Imaging policies (this exclusion criterion would not exclude patient from enrolling in the registry and undergoing PET/CT).
- Patients with documented, clear-cut metastatic disease on conventional workup where PET findings would not potentially alter patient management. In case of uncertainty, the patient will be discussed at multidisciplinary tumor boards and a majority decision will be made
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Princess Margaret Cancer Centre 18F-DCFPyL PET Registry
The purpose of the Princess Margaret Cancer Centre PSMA registry is to assess the contribution of 18F-DCFPyL (PSMA) PET imaging (PET/MR or PET/CT) to the management of patients with prostate cancer (PCa).
Background:
Read more
Currently, patients with intermediate or high risk prostate cancer are staged with CT abdomen and pelvis and bone scan to assess for distant metastases. Patients with biochemical recurrence after primary therapy are restaged in a similar manner. Locally, multiparametric MR of the prostate or prostate bed may also be obtained in select cases.
Patients recruited for this registry will be staged/ restaged with PSMA PET (PET/CT or PET/MR) to determine whether this imaging strategy results in more accurate detection of metastatic disease (for patients undergoing primary staging) or detection of local recurrence or distant disease (for patients undergoing restaging). Choice of imaging method (PET/CT or PET/MR) will be made by one of the study PIs, based on clinical judgement taking into account the specific exam indication, prior recent imaging, and suitability for MR imaging.
Study design:
This is a single arm study to assess the contribution of PSMA PET imaging (PET/MR or PET/CT) to the management of patients with prostate cancer (PCa).
In this prospective trial, the investigators will recruit 200 men whom will undergo PET imaging using an integrated PET/CT scanner or with an integrated PET/MR.
Patients will receive standard treatment for PCa according to UHN/PMH urology oncology site policies.
Treatment outcome including clinical response, blood work including serial serum PSA, and follow-up imaging if performed up to 5 years will be recorded.
Read the detailed description
Prostate cancer (PCa) is the most common cancer among Canadian men. Men diagnosed with localized PCa are placed in low, intermediate and high-risk groups, using the prognostic variables including pathologic Gleason score, T-stage and serum prostate specific antigen (PSA). These risk groups correlate with biochemical failure-free survival and prostate cancer specific mortality [1]. Although PCa is prevalent, the risk of clinical or fatal PCa in a 50 year old man is estimated at only 10% and 3%, respectively [2]. Currently, over 2/3 of men diagnosed with PCa are diagnosed with organ confined, low risk disease (PSA < 10 ng/ml, Gleason score (=GS) 3+3, cT1c) [3]. Management is dependent on tumor grade, size and stage and clinical parameters (e.g. life expectancy) and may range from active surveillance to radical therapy including definitive whole gland treatment (radical prostatectomy (RP), or radiotherapy). Although radical whole gland therapy is effective from an oncological standpoint, it may be associated with significant side effects. A more conservative approach in select patients may be enrollment in an active surveillance program. The concept behind this approach is that small volume, low grade PCa may have an indolent course and may not progress to biological significance in the absence of treatment in the patient's lifetime.
Rationale for this study is to determine in a prospective cohort of patients with unfavorable intermediate-risk or high-risk PCa, whether PSMA PET improves the detection of lymph node and distant metastases as compared to conventional imaging strategies (CT abdomen and bone scintigraphy).
To determine the rate of change in planned management after adding information from PSMA PET in patients with PCa being staged prior to primary therapy or restaged after primary therapy.
The central hypothesis behind the Princess Margaret Cancer Centre PSMA PET registry is that in patients with PCa, PSMA PET will enable more accurate staging and restaging, and improve prognostic stratification as compared to conventional workup. Furthermore, the investigators hypothesize that the addition of PSMA PET to the workup of these patients will change the planned management in a significant proportion of patients.
Primary Objective:
To determine in a prospective cohort of patients with unfavorable intermediate-risk or high-risk PCa, whether PSMA PET improves the detection of lymph node and distant metastases as compared to conventional imaging strategies (CT abdomen and bone scintigraphy).
To determine the rate of change in planned management after adding information from PSMA PET in patients with PCa being staged prior to primary therapy or restaged after primary therapy.
Secondary Objective:
To determine the clinical outcome and rate of biochemical control after therapy. For this purpose, information from clinical notes of routine clinical visits, results of blood tests (such as serum PSA) and follow-up imaging, if performed, will be collected for up to 5 years.
- Conditions
- Carcinoma of Prostate
- Being tested
- 18F-DCFPyL
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-DCFPyLDiagnostic test
The purpose of this study is to determine if use of 18F-DCFPyL would increase the detection of lesions and to better inform your oncologist on the best method of treatment for your disease.
| Study group | Role | What they receive |
|---|---|---|
| 18F-DCFPyL PET/ MR or PET/CT imaging | Experimental | Will use a newer technology called PET-MR that combines a Positron Emission Tomography (PET) scan with Magnetic Resonance Imaging (MRI) scan. This new combined imaging test, where PET and MRI data is gathered at one time, will be performed on an integrated PET-MR scanner located at Toronto General Hospital.
Or technology called PET-CT that combines a Positron Emission Tomography (PET) scan with a computed tomography (CT) scan. This combined imaging test, where PET and CT data is gathered at one time, will be performed on an integrated PET-CT scanner located at Princess Margaret Cancer Centre.
Choice of imaging method (PET/CT or PET/MR) will be made by one of the study PIs, based on clinical judgement taking into account the specific exam indication, prior recent imaging, and suitability for MR imaging. Receives: Diagnostic Test: 18F-DCFPyL |
What is being measured
The primary outcome is the main question the study is designed to answer.
18F-DCFPyL PET changes the detection of lymph node and distant metastases
To determine in a prospective cohort of patients with unfavorable intermediate-risk or high-risk PCa, whether 18F-DCFPyL PET improves the detection of lymph node and distant metastases as compared to conventional imaging strategies (CT abdomen and bone scintigraphy).
Measured: Through study completion up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start27 Apr 2018
- Primary completion3 Oct 2025
- Study completion3 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carcinoma of ProstateStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm study to assess the contribution of 18F-DCFPyL PET imaging (PET/MR or PET/CT) to the management of patients with prostate cancer (PCa).
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535831
- Sponsor's protocol ID
- 17-6021
- Acronym
- PM-PPR
- Status last verified
- Jan 2026
- First submitted
- 21 Apr 2018
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mirshahvalad SA, Basso Dias A, Ortega C, Abreu Gomez JA, Krishna S, Perlis N, Berlin A, van der Kwast T, Jhaveri K, Ghai S, Metser U, Santiago AT, Veit-Haibach P. [18F]F-DCFPyL PET/MRI radiomics for intraprostatic prostate cancer detection and metastases prediction using whole-gland segmentation. Br J Radiol. 2025 Oct 1;98(1174):1606-1614. doi: 10.1093/bjr/tqaf014.
PubMed 39847533Basso Dias A, Finelli A, Bauman G, Veit-Haibach P, Berlin A, Ortega C, Avery L, Metser U. Impact of 18F-DCFPyL PET on Staging and Treatment of Unfavorable Intermediate or High-Risk Prostate Cancer. Radiology. 2022 Sep;304(3):600-608. doi: 10.1148/radiol.211836. Epub 2022 May 24.
PubMed 35608445
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Princess Margaret Cancer Centre 18F-DCFPyL PET Registry
- ClinicalTrials.gov ID
- NCT03535831
- Acronym / sponsor ID
- PM-PPR / 17-6021
- Conditions
- Carcinoma of Prostate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 27 Apr 2018 (actual)
- Primary completion
- 3 Oct 2025 (actual)
- Study completion
- 3 Oct 2025 (actual)
- First posted
- 24 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the Princess Margaret Cancer Centre PSMA registry is to assess the contribution of 18F-DCFPyL (PSMA) PET imaging (PET/MR or PET/CT) to the management of patients with prostate cancer (PCa).
Background:
Currently, patients with intermediate or high risk prostate cancer are staged with CT abdomen and pelvis and bone scan to assess for distant metastases. Patients with biochemical recurrence after primary therapy are restaged in a similar manner. Locally, multiparametric MR of the prostate or prostate bed may also be obtained in select cases.
Patients recruited for this registry will be staged/ restaged with PSMA PET (PET/CT or PET/MR) to determine whether this imaging strategy results in more accurate detection of metastatic disease (for patients undergoing primary staging) or detection of local recurrence or distant disease (for patients undergoing restaging). Choice of imaging method (PET/CT or PET/MR) will be made by one of the study PIs, based on clinical judgement taking into account the specific exam indication, prior recent imaging, and suitability for MR imaging.
Study design:
This is a single arm study to assess the contribution of PSMA PET imaging (PET/MR or PET/CT) to the management of patients with prostate cancer (PCa).
In this prospective trial, the investigators will recruit 200 men whom will undergo PET imaging using an integrated PET/CT scanner or with an integrated PET/MR.
Patients will receive standard treatment for PCa according to UHN/PMH urology oncology site policies.
Treatment outcome including clinical response, blood work including serial serum PSA, and follow-up imaging if performed up to 5 years will be recorded.
Detailed description
Prostate cancer (PCa) is the most common cancer among Canadian men. Men diagnosed with localized PCa are placed in low, intermediate and high-risk groups, using the prognostic variables including pathologic Gleason score, T-stage and serum prostate specific antigen (PSA). These risk groups correlate with biochemical failure-free survival and prostate cancer specific mortality [1]. Although PCa is prevalent, the risk of clinical or fatal PCa in a 50 year old man is estimated at only 10% and 3%, respectively [2]. Currently, over 2/3 of men diagnosed with PCa are diagnosed with organ confined, low risk disease (PSA < 10 ng/ml, Gleason score (=GS) 3+3, cT1c) [3]. Management is dependent on tumor grade, size and stage and clinical parameters (e.g. life expectancy) and may range from active surveillance to radical therapy including definitive whole gland treatment (radical prostatectomy (RP), or radiotherapy). Although radical whole gland therapy is effective from an oncological standpoint, it may be associated with significant side effects. A more conservative approach in select patients may be enrollment in an active surveillance program. The concept behind this approach is that small volume, low grade PCa may have an indolent course and may not progress to biological significance in the absence of treatment in the patient's lifetime.
Rationale for this study is to determine in a prospective cohort of patients with unfavorable intermediate-risk or high-risk PCa, whether PSMA PET improves the detection of lymph node and distant metastases as compared to conventional imaging strategies (CT abdomen and bone scintigraphy).
To determine the rate of change in planned management after adding information from PSMA PET in patients with PCa being staged prior to primary therapy or restaged after primary therapy.
The central hypothesis behind the Princess Margaret Cancer Centre PSMA PET registry is that in patients with PCa, PSMA PET will enable more accurate staging and restaging, and improve prognostic stratification as compared to conventional workup. Furthermore, the investigators hypothesize that the addition of PSMA PET to the workup of these patients will change the planned management in a significant proportion of patients.
Primary Objective:
To determine in a prospective cohort of patients with unfavorable intermediate-risk or high-risk PCa, whether PSMA PET improves the detection of lymph node and distant metastases as compared to conventional imaging strategies (CT abdomen and bone scintigraphy).
To determine the rate of change in planned management after adding information from PSMA PET in patients with PCa being staged prior to primary therapy or restaged after primary therapy.
Secondary Objective:
To determine the clinical outcome and rate of biochemical control after therapy. For this purpose, information from clinical notes of routine clinical visits, results of blood tests (such as serum PSA) and follow-up imaging, if performed, will be collected for up to 5 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm study to assess the contribution of 18F-DCFPyL PET imaging (PET/MR or PET/CT) to the management of patients with prostate cancer (PCa).
| Arm | Type | Receives |
|---|---|---|
| 18F-DCFPyL PET/ MR or PET/CT imaging | Experimental | Diagnostic Test: 18F-DCFPyLWill use a newer technology called PET-MR that combines a Positron Emission Tomography (PET) scan with Magnetic Resonance Imaging (MRI) scan. This new combined imaging test, where PET and MRI data is gathered at one time, will be performed on an integrated PET-MR scanner located at Toronto General Hospital. Or technology called PET-CT that combines a Positron Emission Tomography (PET) scan with a computed tomography (CT) scan. This combined imaging test, where PET and CT data is gathered at one time, will be performed on an integrated PET-CT scanner located at Princess Margaret Cancer Centre. Choice of imaging method (PET/CT or PET/MR) will be made by one of the study PIs, based on clinical judgement taking into account the specific exam indication, prior recent imaging, and suitability for MR imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients will be eligible for inclusion in this study if they meet all of the following criteria:
- Age ≥ 18 years
- Histologic diagnosis of carcinoma of prostate
- Being staged or restaged for any of the following indications:
- Staging of patients with:
Key exclusion criteria (4 listed)
- Patients will be ineligible to participate in this study if they meet any of the following criteria:
- Inability to lie still for PET/CT or PET/MR examination
- For patients undergoing PET/MR only, any contraindication to MRI as per Joint Department of Medical Imaging policies (this exclusion criterion would not exclude patient from enrolling in the registry and undergoing PET/CT).
- Patients with documented, clear-cut metastatic disease on conventional workup where PET findings would not potentially alter patient management. In case of uncertainty, the patient will be discussed at multidisciplinary tumor boards and a majority decision will be made
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-DCFPyLThe purpose of this study is to determine if use of 18F-DCFPyL would increase the detection of lesions and to better inform your oncologist on the best method of treatment for your disease. | Diagnostic test | 18F-DCFPyL PET/ MR or PET/CT imaging |
Primary outcome
18F-DCFPyL PET changes the detection of lymph node and distant metastases
Time frame: Through study completion up to 5 years
To determine in a prospective cohort of patients with unfavorable intermediate-risk or high-risk PCa, whether 18F-DCFPyL PET improves the detection of lymph node and distant metastases as compared to conventional imaging strategies (CT abdomen and bone scintigraphy).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Derived from this study: PubMed 39847533Mirshahvalad SA, Basso Dias A, Ortega C, Abreu Gomez JA, Krishna S, Perlis N, Berlin A, van der Kwast T, Jhaveri K, Ghai S, Metser U, Santiago AT, Veit-Haibach P. [18F]F-DCFPyL PET/MRI radiomics for intraprostatic prostate cancer detection and metastases prediction using whole-gland segmentation. Br J Radiol. 2025 Oct 1;98(1174):1606-1614. doi: 10.1093/bjr/tqaf014.
- Derived from this study: PubMed 35608445Basso Dias A, Finelli A, Bauman G, Veit-Haibach P, Berlin A, Ortega C, Avery L, Metser U. Impact of 18F-DCFPyL PET on Staging and Treatment of Unfavorable Intermediate or High-Risk Prostate Cancer. Radiology. 2022 Sep;304(3):600-608. doi: 10.1148/radiol.211836. Epub 2022 May 24.
- Individual participant dataSharing planned: Undecided
Related trials for Carcinoma of Prostate
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-DCFPyL in people with Carcinoma of Prostate, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18F-DCFPyL PET changes the detection of lymph node and distant metastases (time frame: Through study completion up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03535831, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.