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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02813226
Recruitment Status : Active, not recruiting
First Posted : June 24, 2016
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Molecular Imaging Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : February 16, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Imaging
Molecular Imaging
Other: Molecular Imaging
Baseline and follow-up FDG PET-CT and DCFPyL PET-CT




Primary Outcome Measures :
  1. Functional imaging metabolic response contrasted with conventional imaging response [ Time Frame: 10 weeks ]
    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 :
  1. Functional imaging response [ Time Frame: 10 weeks ]
    The percent change in the SUVmax of the most intensely FDG/DCFPyL avid lesion relative to Baseline.

  2. Radiological progression free survival. [ Time Frame: 3 years ]
    The time from registration to the first date of radiographic disease progression in bone or soft tissue or to the date of death

  3. Prostate specific antigen (PSA) response [ Time Frame: 3 years ]
    The time from registration to the date of PSA progression

  4. Progressive Disease (example change in treatment, skeletal related event) [ Time Frame: 3 years ]
    The time from registration to initiation of anti-cancer intervention or death from any cause.

  5. Overall Survival [ Time Frame: 3 years ]
    The time from registration to the date of death from any cause.



Information from the National Library of Medicine

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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:

  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

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): NCT02813226


Locations
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Canada, Ontario
Juravinski Hospital and Cancer Centre
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Sunnybrook-Odette Cancer Centre
Toronto, Ontario, Canada
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Investigators
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Principal Investigator: Katherine Zukotynski Hamilton Health Sciences Corporation
Principal Investigator: Eric Winquist London Health Sciences Centre

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Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT02813226     History of Changes
Other Study ID Numbers: OCOG-2016-MISTER
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ontario Clinical Oncology Group (OCOG):
castration-resistant
molecular imaging
abiraterone acetate
enzalutamide
metabolic response

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases