Prostate CancerPICsNCT02793284
Advanced Prostate Imaging of Recurrent Cancer After Radiotherapy
A study testing 18F-DCFPyL PET/CT scan in people with Prostate Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 4 sites in Canada.
Trial summary
The investigators are attempting to determine if a new form of imaging called 18F-DCFPyL PET/CT is helpful to physicians in deciding how to manage suspected prostate cancer recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 18F-DCFPyL PET/CT scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesCanada
- Study dates
- 9 Jan 2017to 15 Feb 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous external beam radiotherapy or brachytherapy for localized disease (T1-T2, Gleason < 7 and PSA < 20) or (T1-2, Gleason 8, prostatic specific antigen (PSA)<10)
- Interval to biochemical failure more than 12 months from last radical therapeutic intervention
- Biochemical failure confirmed on at least 3 consecutive PSA measurements each taken at least 1 month apart
- PSA at time of enrollment more than nadir+2.0ng/ml (Phoenix definition of biochemical failure)
- Karnofsky performance status 70 or better [Eastern Cooperative Oncology Group (ECOG) 0,1]
- Total serum testosterone level >1nmol/l (if prior treatment with hormone therapy)
Who cannot join
- CT or bone scan within 6 months of enrollment
- Patients whose prior radiotherapy was delivered with palliative intent
- Patients with known metastatic disease
- Extensive co-morbidities precluding potential ablative salvage procedures
- Prior history of invasive non-cutaneous malignant disease unless disease free for at least 5 years
- Already on systemic anticancer treatment (androgen deprivation or chemotherapy)
Show all 9Show fewer
- Inability to comply with the imaging requirements e.g. inability to lie supine for one hour
- Allergy or contraindication to MRI or CT contrast agents or PET tracer to be used as part of the imaging
- Insufficient renal function [estimated glomerular filtration rate (eGFR) < 30 mL/min]
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Hamilton Health Sciences Centre
Hamilton, Ontario
London Regional Cancer Program of the Lawson Health Research Institute
London, Ontario, N6A 4L6
Princess Margaret Cancer Centre
Toronto, Ontario
Toronto Sunnybrook Cancer Centre
Toronto, Ontario
About this study
The investigators are attempting to determine if a new form of imaging called 18F-DCFPyL PET/CT is helpful to physicians in deciding how to manage suspected prostate cancer recurrence. This imaging uses a Positron Emission Tomography/Computed Tomography (PET/CT) scan using a radioactive tracer 18F-DCFPyL that is concentrated in prostate cancer cells and can potentially identify cancer cells throughout the body. The combination of 18F-DCFPyL PET/CT can potentially identify areas of prostate cancer recurrence not seen with usual imaging [bone scan, computed tomography (CT) thorax, abdomen and pelvis, plus multi-parametric magnetic resonance imaging (MRI)].
Read the detailed description
The study will evaluate the utility of investigational restaging with 18F-DCFPyL PET/CT following conventional imaging (bone scan, CT thorax, abdomen and pelvis plus multi-parametric pelvic MRI) in detecting the prevalence of metastatic disease among men with biochemical recurrence after radical radiotherapy treatment to the prostate. Men treated with primary radiation with external beam or brachytherapy will be eligible. Eighty (80) eligible consenting patients with biochemical recurrence and potentially suitable for local salvage or targeted ablative therapies will be registered and imaged with conventional imaging (bone scan, CT thorax, abdomen and pelvis plus multi-parametric pelvic MRI) followed by investigational restaging with 18F-DCFPyL PET/CT. Characterizing sites of disease identified by the combination of 18F-DCFPyL PET/CT with conventional imaging versus 18F-DCFPyL PET/CT alone will be used to explore the potential of 18F-DCFPyL PET/CT as a single restaging study in men with biochemical recurrence. While further investigation and treatment after restaging will be at the discretion of the investigator and the patient, the actual treatment/management, treatment outcomes and quality of life will be recorded in an electronic database at 6, 12, 24 and 36 months after re-staging. Such longitudinal analyses of management and outcomes will be useful in characterizing the disease trajectory, response to treatment and quality of life for patients whose recurrent disease is managed based on comprehensive restaging using the combination of conventional imaging and 18F-DCFPyL PET/CT.
- Conditions
- Prostate Cancer
- Being tested
- 18F-DCFPyL 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.
18F-DCFPyL PET/CT scanRadiation
PET/CT scan using the radioactive agent 18F-DCFPyL
| Study group | Role | What they receive |
|---|---|---|
| Intervention 18F-DCFPyL PET/CT | Experimental | 18F-DCFPyL PET/CT scan obtained at the time of restaging for biochemical recurrence after primary radiotherapy Receives: Radiation: 18F-DCFPyL PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of extra-prostatic disease
Number of men with extra-prostatic disease detected by either 18F-DCFPyL PET/CT or conventional imaging, divided by the number of men undergoing imaging.
Measured: 2 weeks post re-staging
Secondary outcomes (8)
Detection of extra-prostatic disease exclusive to 18F-DCFPyl PET/CT
Number of men who have extra-prostatic disease detected exclusively on 18F-DCFPyL PET/CT.
Measured: 2 weeks post re-staging imaging
Detection of lesions per subject and overall population
The number of extra-prostatic lesions detected by 18F-DCFPyL PET/CT versus conventional imaging alone will be compared on a per subject and overall population basis.
Measured: 2 weeks post re-staging imaging
Location of extra-prostatic lesions
The location of extra-prostatic lesions detected by 18F-DCFPyL PET/CT versus conventional imaging.
Measured: 2 weeks post re-staging imaging
Planned treatment management based on re-staging imaging
Planned treatment management based on the information from 18F-DCFPyL PET/CT compared to conventional imaging, to characterize the impact on patient care.
Measured: 2 weeks post re-staging imaging
Actual treatment management assessed by physician completed study specific questionnaire
A questionnaire developed specifically for the study, called the Post-PET Management Form, will be completed by the attending physician, noting any changes to the treatment based on the results of the 18F-DCFPyL PET/CT imaging. Treatment options may include, but are not limited to, surgery, radiotherapy, androgen deprivation therapy, cryotherapy, and observation.
Measured: 6 months, 12 months, 24 months, and 36 months after re-staging imaging
Disease status (Is the patient alive, deceased, has active disease, or no evidence of disease?)
The investigators want to determine if the patient is alive, deceased, has active disease or no evidence of disease, at approximately yearly intervals. The source of this data could come from physician notes, lab tests, imaging reports, pathology report, or directly from the patient.
Measured: 6 months, 12 months, 24 months, and 36 months after re-staging imaging
Quality of Life
Quality of life is measured using the Functional Assessment of Cancer Therapy - Prostate (FACT-P) and Expanded Prostate Cancer Index Composite (EPIC) standardized questionnaires.
Measured: 6 months, 12 months, 24 months, and 36 months after re-staging imaging
Disease burden measured by serum and urine biomarkers versus imaging
Baseline serum and urine will be obtained for future correlative studies of novel biomarkers of disease burden for comparison against measures of disease burden provided by imaging.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study start9 Jan 2017
- Primary completion19 Jun 2018
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Institute for Cancer Research
- Responsible party
- Principal investigator, Glenn Bauman, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Glenn Bauman, MD, Principal investigator, London Regional Cancer Program of the Lawson Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793284
- Sponsor's protocol ID
- PICs
- Acronym
- PICs
- Status last verified
- Mar 2022
- First submitted
- 26 May 2016
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Prostate Imaging of Recurrent Cancer After Radiotherapy
- ClinicalTrials.gov ID
- NCT02793284
- Acronym / sponsor ID
- PICs / PICs
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Ontario Institute for Cancer Research
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 19 Jun 2018 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 8 Jun 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.
The investigators are attempting to determine if a new form of imaging called 18F-DCFPyL PET/CT is helpful to physicians in deciding how to manage suspected prostate cancer recurrence. This imaging uses a Positron Emission Tomography/Computed Tomography (PET/CT) scan using a radioactive tracer 18F-DCFPyL that is concentrated in prostate cancer cells and can potentially identify cancer cells throughout the body. The combination of 18F-DCFPyL PET/CT can potentially identify areas of prostate cancer recurrence not seen with usual imaging [bone scan, computed tomography (CT) thorax, abdomen and pelvis, plus multi-parametric magnetic resonance imaging (MRI)].
Detailed description
The study will evaluate the utility of investigational restaging with 18F-DCFPyL PET/CT following conventional imaging (bone scan, CT thorax, abdomen and pelvis plus multi-parametric pelvic MRI) in detecting the prevalence of metastatic disease among men with biochemical recurrence after radical radiotherapy treatment to the prostate. Men treated with primary radiation with external beam or brachytherapy will be eligible. Eighty (80) eligible consenting patients with biochemical recurrence and potentially suitable for local salvage or targeted ablative therapies will be registered and imaged with conventional imaging (bone scan, CT thorax, abdomen and pelvis plus multi-parametric pelvic MRI) followed by investigational restaging with 18F-DCFPyL PET/CT. Characterizing sites of disease identified by the combination of 18F-DCFPyL PET/CT with conventional imaging versus 18F-DCFPyL PET/CT alone will be used to explore the potential of 18F-DCFPyL PET/CT as a single restaging study in men with biochemical recurrence. While further investigation and treatment after restaging will be at the discretion of the investigator and the patient, the actual treatment/management, treatment outcomes and quality of life will be recorded in an electronic database at 6, 12, 24 and 36 months after re-staging. Such longitudinal analyses of management and outcomes will be useful in characterizing the disease trajectory, response to treatment and quality of life for patients whose recurrent disease is managed based on comprehensive restaging using the combination of conventional imaging and 18F-DCFPyL PET/CT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention 18F-DCFPyL PET/CT | Experimental | Radiation: 18F-DCFPyL PET/CT scan18F-DCFPyL PET/CT scan obtained at the time of restaging for biochemical recurrence after primary radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Previous external beam radiotherapy or brachytherapy for localized disease (T1-T2, Gleason < 7 and PSA < 20) or (T1-2, Gleason 8, prostatic specific antigen (PSA)<10)
- Interval to biochemical failure more than 12 months from last radical therapeutic intervention
- Biochemical failure confirmed on at least 3 consecutive PSA measurements each taken at least 1 month apart
- PSA at time of enrollment more than nadir+2.0ng/ml (Phoenix definition of biochemical failure)
- Karnofsky performance status 70 or better [Eastern Cooperative Oncology Group (ECOG) 0,1]
Key exclusion criteria (9 listed)
- CT or bone scan within 6 months of enrollment
- Patients whose prior radiotherapy was delivered with palliative intent
- Patients with known metastatic disease
- Extensive co-morbidities precluding potential ablative salvage procedures
- Prior history of invasive non-cutaneous malignant disease unless disease free for at least 5 years
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-DCFPyL PET/CT scanPET/CT scan using the radioactive agent 18F-DCFPyL | Radiation | Intervention 18F-DCFPyL PET/CT |
Primary outcome
Detection of extra-prostatic disease
Time frame: 2 weeks post re-staging
Number of men with extra-prostatic disease detected by either 18F-DCFPyL PET/CT or conventional imaging, divided by the number of men undergoing imaging.
8 secondary outcomes
Detection of extra-prostatic disease exclusive to 18F-DCFPyl PET/CT
Time frame: 2 weeks post re-staging imaging
Detection of lesions per subject and overall population
Time frame: 2 weeks post re-staging imaging
Location of extra-prostatic lesions
Time frame: 2 weeks post re-staging imaging
Planned treatment management based on re-staging imaging
Time frame: 2 weeks post re-staging imaging
Actual treatment management assessed by physician completed study specific questionnaire
Time frame: 6 months, 12 months, 24 months, and 36 months after re-staging imaging
Disease status (Is the patient alive, deceased, has active disease, or no evidence of disease?)
Time frame: 6 months, 12 months, 24 months, and 36 months after re-staging imaging
Quality of Life
Time frame: 6 months, 12 months, 24 months, and 36 months after re-staging imaging
Disease burden measured by serum and urine biomarkers versus imaging
Time frame: Baseline
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 28 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Glenn Bauman, MD principal investigator
London Regional Cancer Program of the Lawson Health Research Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-DCFPyL PET/CT scan in people with Prostate Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 4 sites 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 6 inclusion and 9 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 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Detection of extra-prostatic disease (time frame: 2 weeks post re-staging). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2022.