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Advanced Prostate Imaging of Recurrent Cancer After Radiotherapy (PICs)

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ClinicalTrials.gov Identifier: NCT02793284
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : July 6, 2018
Sponsor:
Collaborator:
Ontario Institute for Cancer Research
Information provided by (Responsible Party):
Glenn Bauman, Lawson Health Research Institute

Brief 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. 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)].

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: 18F-DCFPyL PET/CT scan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Advanced Prostate Imaging of Recurrent Cancer After Radiotherapy
Actual Study Start Date : January 9, 2017
Actual Primary Completion Date : June 19, 2018
Actual Study Completion Date : June 19, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention 18F-DCFPyL PET/CT
18F-DCFPyL PET/CT scan obtained at the time of restaging for biochemical recurrence after primary radiotherapy
Radiation: 18F-DCFPyL PET/CT scan
PET/CT scan using the radioactive agent 18F-DCFPyL




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Detection of extra-prostatic disease exclusive to 18F-DCFPyl PET/CT [ Time Frame: 2 weeks post re-staging imaging ]
    Number of men who have extra-prostatic disease detected exclusively on 18F-DCFPyL PET/CT.

  2. Detection of lesions per subject and overall population [ Time Frame: 2 weeks post re-staging imaging ]
    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.

  3. Location of extra-prostatic lesions [ Time Frame: 2 weeks post re-staging imaging ]
    The location of extra-prostatic lesions detected by 18F-DCFPyL PET/CT versus conventional imaging.

  4. Planned treatment management based on re-staging imaging [ Time Frame: 2 weeks post 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.

  5. 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 ]
    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.

  6. 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 ]
    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.

  7. Quality of Life [ Time Frame: 6 months, 12 months, 24 months, and 36 months after re-staging imaging ]
    Quality of life is measured using the Functional Assessment of Cancer Therapy - Prostate (FACT-P) and Expanded Prostate Cancer Index Composite (EPIC) standardized questionnaires.

  8. Disease burden measured by serum and urine biomarkers versus imaging [ Time Frame: Baseline ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
  • 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]

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02793284


Locations
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Canada, Ontario
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada
London Regional Cancer Program of the Lawson Health Research Institute
London, Ontario, Canada, N6A 4L6
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Toronto Sunnybrook Cancer Centre
Toronto, Ontario, Canada
Sponsors and Collaborators
Lawson Health Research Institute
Ontario Institute for Cancer Research
Investigators
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Principal Investigator: Glenn Bauman, MD London Regional Cancer Program of the Lawson Health Research Institute

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Responsible Party: Glenn Bauman, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02793284     History of Changes
Other Study ID Numbers: PICs
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Recurrence
Disease Attributes
Pathologic Processes