Prostatic NeoplasmsNCT02899312
PSMA PET/CT for Assessment of Recurrent Prostate Cancer
An observational study of Prostatic Neoplasms and Prostate Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms, Prostate Cancer
- What is being tested?
- PSMA PET/CT scan
- How many people
- 2,244 participants
- Where
- 1 siteCanada
- Study dates
- 16 Mar 2017to Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The purpose of this study is to evaluate the diagnostic utility of 18F-DCFPyL PET/CT in identifying sites of prostate cancer recurrence where conventional imaging has been negative or equivocal. Concordance with histology, imaging or follow up will be assessed. This study will also assess the clinical impact of 18F-DCFPyL PET/CT on patient management.
Who may be able to join
- Known PC with a biochemical recurrence (BR) after initial curative therapy with radical prostatectomy, with a documented history of failure of PSA to fall to undetectable levels (PSA persistence) or undetectable PSA after radical prostatectomy with a subsequent detectable PSA that increased on 2 or more determinations (PSA recurrence). The patient may have received treatment following documentation of PSA persistence or PSA recurrence. The most recent PSA measurement must be greater than 0.4 ng/mL.
- Participants with findings on other examinations (such as plain x-ray, CT, MRI or bone scintigraphy and others) that are suspicious for metastatic disease but not conclusively diagnostic of metastatic disease.
- Known PC with BR after initial curative therapy with radiation therapy (including brachytherapy), with a PSA level >2 ng/mL above the nadir after radiation therapy.
- Castration resistant PC with a minimum PSA of 2.0 ng/mL with 2 consecutive rises above the nadir and castrate levels of testosterone (<1.7 nmol/L). Treatment does not need to be discontinued before the 18F-DCFPyL scan.
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
Who cannot join
- Medically unstable (eg. acute illness, unstable vital signs)
- Unable to lie supine for the duration of imaging
- Unable to provide written consent
- Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluorine-18 - 2-(3-(1-carboxy-5-[(6-[18F]Fluoro-pyridine-3-carbonyl)-Amino]-Pentyl)-Ureido)-Pentanedioic Acid (18F-DCFPyL) Positron Emission Tomography / Computed Tomography (PET/CT) for Assessment of Recurrent Prostate Cancer
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)-pentanedioic 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.
Read the detailed 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).
- Conditions
- Prostatic Neoplasms, Prostate Cancer
- Being tested
- PSMA PET/CT scan
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA PET/CT scanDrug
Also called 18F-DCFPyL PET/CT
All participants will undergo the same procedures listed in "Detailed Description" in the protocol section.
What is being measured
The primary outcome is the main question the study is designed to answer.
superiority of 18F-DCFPyL PET/CT over conventional imaging for detection of recurrent prostate cancer.
Comparison to conventional imaging studies, pathology and clinical follow-up up to 3 years after PSMA imaging.
Measured: 3 years after the PSMA PET scan
Secondary outcomes (1)
clinical impact of 18F-DCFPyL PET/CT
To assess the clinical impact of 18F-DCFPyL scans inpatient management. Eg, surgical resection or localized radiation.
Measured: 6 months after the PSMA PET scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study start16 Mar 2017
- Primary completionNov 2027 (estimated)
- Study completionJun 2030 (estimated)
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 Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francois Benard, MD, Principal investigator, BC Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899312
- Sponsor's protocol ID
- H16-01551
- Status last verified
- Nov 2024
- First submitted
- 9 Sep 2016
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to make individual participant data available?
Publications
Harsini S, Martineau P, Plaha S, Saprunoff H, Chen C, Bishop J, Tyldesley S, Wilson D, Benard F. Prognostic significance of a negative PSMA PET/CT in biochemical recurrence of prostate cancer. Cancer Imaging. 2024 Aug 30;24(1):117. doi: 10.1186/s40644-024-00752-1.
PubMed 39210431Harsini S, Wilson D, Saprunoff H, Allan H, Gleave M, Goldenberg L, Chi KN, Kim-Sing C, Tyldesley S, Benard F. Outcome of patients with biochemical recurrence of prostate cancer after PSMA PET/CT-directed radiotherapy or surgery without systemic therapy. Cancer Imaging. 2023 Mar 17;23(1):27. doi: 10.1186/s40644-023-00543-0.
PubMed 36932416
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorine-18 - 2-(3-(1-carboxy-5-[(6-[18F]Fluoro-pyridine-3-carbonyl)-Amino]-Pentyl)-Ureido)-Pentanedioic Acid (18F-DCFPyL) Positron Emission Tomography / Computed Tomography (PET/CT) for Assessment of Recurrent Prostate Cancer
- ClinicalTrials.gov ID
- NCT02899312
- Acronym / sponsor ID
- H16-01551
- Conditions
- Prostatic Neoplasms, Prostate Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,244 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 14 Sep 2016 (estimated)
- 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.
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)-pentanedioic 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.
Detailed 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The purpose of this study is to evaluate the diagnostic utility of 18F-DCFPyL PET/CT in identifying sites of prostate cancer recurrence where conventional imaging has been negative or equivocal. Concordance with histology, imaging or follow up will be assessed. This study will also assess the clinical impact of 18F-DCFPyL PET/CT on patient management.
Key inclusion criteria (5 listed)
- Known PC with a biochemical recurrence (BR) after initial curative therapy with radical prostatectomy, with a documented history of failure of PSA to fall to undetectable levels (PSA persistence) or undetectable PSA after radical prostatectomy with a subsequent detectable PSA that increased on 2 or more determinations (PSA recurrence). The patient may have received treatment following documentation of PSA persistence or PSA recurrence. The most recent PSA measurement must be greater than 0.4 ng/mL.
- Participants with findings on other examinations (such as plain x-ray, CT, MRI or bone scintigraphy and others) that are suspicious for metastatic disease but not conclusively diagnostic of metastatic disease.
- Known PC with BR after initial curative therapy with radiation therapy (including brachytherapy), with a PSA level >2 ng/mL above the nadir after radiation therapy.
- Castration resistant PC with a minimum PSA of 2.0 ng/mL with 2 consecutive rises above the nadir and castrate levels of testosterone (<1.7 nmol/L). Treatment does not need to be discontinued before the 18F-DCFPyL scan.
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
Key exclusion criteria (4 listed)
- Medically unstable (eg. acute illness, unstable vital signs)
- Unable to lie supine for the duration of imaging
- Unable to provide written consent
- Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm)
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 |
|---|---|---|
| PSMA PET/CT scanAlso: 18F-DCFPyL PET/CTAll participants will undergo the same procedures listed in "Detailed Description" in the protocol section. | Drug | – |
Primary outcome
superiority of 18F-DCFPyL PET/CT over conventional imaging for detection of recurrent prostate cancer.
Time frame: 3 years after the PSMA PET scan
Comparison to conventional imaging studies, pathology and clinical follow-up up to 3 years after PSMA imaging.
1 secondary outcome
clinical impact of 18F-DCFPyL PET/CT
Time frame: 6 months after the PSMA PET scan
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Derived from this study: PubMed 39210431Harsini S, Martineau P, Plaha S, Saprunoff H, Chen C, Bishop J, Tyldesley S, Wilson D, Benard F. Prognostic significance of a negative PSMA PET/CT in biochemical recurrence of prostate cancer. Cancer Imaging. 2024 Aug 30;24(1):117. doi: 10.1186/s40644-024-00752-1.
- Derived from this study: PubMed 36932416Harsini S, Wilson D, Saprunoff H, Allan H, Gleave M, Goldenberg L, Chi KN, Kim-Sing C, Tyldesley S, Benard F. Outcome of patients with biochemical recurrence of prostate cancer after PSMA PET/CT-directed radiotherapy or surgery without systemic therapy. Cancer Imaging. 2023 Mar 17;23(1):27. doi: 10.1186/s40644-023-00543-0.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available?
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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.
Francois Benard, MD principal investigator
BC Cancer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms and Prostate Cancer, run by British Columbia Cancer Agency 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 5 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: under way, not looking for participants, as of the sponsor's last update on 7 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
superiority of 18F-DCFPyL PET/CT over conventional imaging for detection of recurrent prostate cancer. (time frame: 3 years after the PSMA PET scan). 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 NCT02899312, 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 7 Nov 2024.