Advanced Prostate Imaging of Recurrent Cancer After Radiotherapy

NCT02793284 | Completed

• 1 other identifier: PICs
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

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 \[bone scan, computed tomography (CT) thorax, abdomen and pelvis, plus multi-parametric magnetic resonance imaging (MRI)\].

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks post re-staging

Secondary Outcomes (8)

• Detection of extra-prostatic disease exclusive to 18F-DCFPyl PET/CT

  2 weeks post re-staging imaging

• Detection of lesions per subject and overall population

  2 weeks post re-staging imaging

• Location of extra-prostatic lesions

  2 weeks post re-staging imaging

• Planned treatment management based on re-staging imaging

  2 weeks post re-staging imaging

• Actual treatment management assessed by physician completed study specific questionnaire

  6 months, 12 months, 24 months, and 36 months after re-staging imaging

Study Arms (1)

Intervention 18F-DCFPyL PET/CT

EXPERIMENTAL

18F-DCFPyL PET/CT scan obtained at the time of restaging for biochemical recurrence after primary radiotherapy

Radiation: 18F-DCFPyL PET/CT scan

Interventions

18F-DCFPyL PET/CT scan RADIATION

PET/CT scan using the radioactive agent 18F-DCFPyL

Intervention 18F-DCFPyL PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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 \[estimated glomerular filtration rate (eGFR) \< 30 mL/min\]

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Ontario Institute for Cancer Research: collaborator

Study Sites (4)

Hamilton Health Sciences Centre

Hamilton, Ontario, Canada

Location

London Regional Cancer Program of the Lawson Health Research Institute

London, Ontario, N6A 4L6, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Location

Toronto Sunnybrook Cancer Centre

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Glenn Bauman, MD

  London Regional Cancer Program of the Lawson Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 8, 2016
• Study Start: January 9, 2017
• Primary Completion: June 19, 2018
• Study Completion: February 15, 2022
• Last Updated: March 28, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)