NCT02813226

Brief Summary

In this study 30 men, with advanced metastatic Castration-Resistant Prostate Cancer (CRPC) planned to have hormonal treatment, will undergo conventional imaging and functional imaging prior to treatment and post treatment to determine if changes in imaging results will be prognostic of outcome. Patients will have a clinical follow-up every 3 months post randomization for one year and followed for survival at Years 2 and 3.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

February 16, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2021

Completed
Last Updated

December 21, 2021

Status Verified

December 1, 2021

Enrollment Period

3.1 years

First QC Date

June 22, 2016

Last Update Submit

December 20, 2021

Conditions

Prostate Cancer

Keywords

castration-resistantmolecular imagingabiraterone acetateenzalutamidemetabolic response

Outcome Measures

Primary Outcomes (1)

  • Functional imaging metabolic response contrasted with conventional imaging response

    Percent change of the average maximum standardized uptake value (SUVmax) of target lesions in contrast with conventional imaging soft tissue and bone response between the baseline scans and the Week 10 scans.

    10 weeks

Secondary Outcomes (5)

  • Functional imaging response

    10 weeks

  • Radiological progression free survival.

    3 years

  • Prostate specific antigen (PSA) response

    3 years

  • Progressive Disease (example change in treatment, skeletal related event)

    3 years

  • Overall Survival

    3 years

Study Arms (1)

Imaging

OTHER

Molecular Imaging

Other: Molecular Imaging

Interventions

Molecular ImagingOTHER

Baseline and follow-up FDG PET-CT and DCFPyL PET-CT

Imaging

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Objectively documented metastatic prostate cancer progression with either of the following:
  • At least one rising PSA over a minimum of one week interval within six weeks of study registration, or
  • Radiographic progression in soft tissue and/or bone within six weeks of study registration
  • Ongoing androgen deprivation therapy with serum testosterone \<50 ng/dL (\<1.7 nmol/L).
  • Planned to start abiraterone acetate or enzalutamide.

You may not qualify if:

  • Age \< 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status \>2.
  • Planned to receive palliative radiotherapy within the next 12 weeks.
  • Hemoglobin \< 90 g/L independent of transfusion.
  • Platelet count \< 50 x 10\^9 / L.
  • Serum albumin \< 30 g/L.
  • Serum creatinine \> 1.5 x Upper Limit of Normal (ULN) or a calculated creatinine clearance \<30 L/min.
  • Contraindications to FDG.
  • Inability to lie supine for imaging with PET-CT.
  • Inability to undergo CT due to known allergy to contrast.
  • Inadequate hepatic function: (i) Bilirubin \>1.5 x ULN, and (ii) Serum glutamic oxaloacetic transaminase (SGOT) \>3 x ULN
  • Inability to complete the study or required follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Juravinski Hospital and Cancer Centre

Hamilton, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

Sunnybrook-Odette Cancer Centre

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Molecular Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisMolecular Probe TechniquesInvestigative Techniques

Study Officials

  • Katherine Zukotynski

    Hamilton Health Sciences Corporation

    PRINCIPAL INVESTIGATOR

  • Eric Winquist

    London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2016

First Posted

June 24, 2016

Study Start

February 16, 2017

Primary Completion

March 20, 2020

Study Completion

December 17, 2021

Last Updated

December 21, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)