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Assessment of New Molecular Imaging Strategies for Prostate Cancer (MISTER)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Molecular Imaging
Sponsored by
Ontario Clinical Oncology Group (OCOG)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prostate Cancer focused on measuring castration-resistant, molecular imaging, abiraterone acetate, enzalutamide, metabolic response

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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
  2. Ongoing androgen deprivation therapy with serum testosterone <50 ng/dL (<1.7 nmol/L).
  3. Planned to start abiraterone acetate or enzalutamide.

Exclusion Criteria:

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

Sites / Locations

  • Juravinski Hospital and Cancer Centre
  • London Health Sciences Centre
  • Sunnybrook-Odette Cancer Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Imaging

Arm Description

Molecular Imaging

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Functional imaging response
The percent change in the SUVmax of the most intensely FDG/DCFPyL avid lesion relative to Baseline.
Radiological progression free survival.
The time from registration to the first date of radiographic disease progression in bone or soft tissue or to the date of death
Prostate specific antigen (PSA) response
The time from registration to the date of PSA progression
Progressive Disease (example change in treatment, skeletal related event)
The time from registration to initiation of anti-cancer intervention or death from any cause.
Overall Survival
The time from registration to the date of death from any cause.

Full Information

First Posted
June 22, 2016
Last Updated
December 20, 2021
Sponsor
Ontario Clinical Oncology Group (OCOG)
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1. Study Identification

Unique Protocol Identification Number
NCT02813226
Brief Title
Assessment of New Molecular Imaging Strategies for Prostate Cancer
Acronym
MISTER
Official Title
Assessment of New Molecular Imaging Strategies for Prostate Cancer: Predictive Value of Established and Novel Positron Emission Tomography (PET) Radiotracers in Castration-Resistant Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
February 16, 2017 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
December 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ontario Clinical Oncology Group (OCOG)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
In this study 30 men, with advanced metastatic CRPC intended to have abiraterone acetate or enzalutamide hormonal treatment will undergo conventional imaging including a 99mTc-Methyl diphosphonate (MDP) bone scan and Computed Tomography (CT) of the abdomen and pelvis, and functional imaging with 18F-fluorodeoxyglucose (FDG) PET-CT and 2-(3-(1-carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl)-ureido)-pentanedioic acid (18F-DCFPyL) PET-CT one to four weeks prior to hormonal treatment and approximately 10 weeks post hormonal treatment. Prostate Specific Antigen (PSA) will also be obtained at baseline and every three months in the first year. Baseline imaging of disease and changes between baseline and follow-up imaging on 18F-FDG PET-CT and 18F-DCFPyL PET-CT will be compared with standard of care imaging (99mTc-MDP bone scan and CT of the abdomen/pelvis) as well as with clinical evaluation including response to therapy and progression of disease. This information could be used by clinicians to guide androgen receptor (AR) - targeted therapy. Patients will have a clinical follow-up every 3 months post randomization for one year and will be followed for survival at Years 2 and 3.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
castration-resistant, molecular imaging, abiraterone acetate, enzalutamide, metabolic response

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imaging
Arm Type
Other
Arm Description
Molecular Imaging
Intervention Type
Other
Intervention Name(s)
Molecular Imaging
Intervention Description
Baseline and follow-up FDG PET-CT and DCFPyL PET-CT
Primary Outcome Measure Information:
Title
Functional imaging metabolic response contrasted with conventional imaging response
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Functional imaging response
Description
The percent change in the SUVmax of the most intensely FDG/DCFPyL avid lesion relative to Baseline.
Time Frame
10 weeks
Title
Radiological progression free survival.
Description
The time from registration to the first date of radiographic disease progression in bone or soft tissue or to the date of death
Time Frame
3 years
Title
Prostate specific antigen (PSA) response
Description
The time from registration to the date of PSA progression
Time Frame
3 years
Title
Progressive Disease (example change in treatment, skeletal related event)
Description
The time from registration to initiation of anti-cancer intervention or death from any cause.
Time Frame
3 years
Title
Overall Survival
Description
The time from registration to the date of death from any cause.
Time Frame
3 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Zukotynski
Organizational Affiliation
Hamilton Health Sciences Corporation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Winquist
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juravinski Hospital and Cancer Centre
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook-Odette Cancer Centre
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessment of New Molecular Imaging Strategies for Prostate Cancer

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