MISTER: Assessment of New Molecular Imaging Strategies for Prostate Cancer

Sponsor

Ontario Clinical Oncology Group (OCOG) (Other)

Overall Status

Completed

CT.gov ID

NCT02813226

Collaborator

(none)

Enrollment

Locations

Arm

Actual Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Other: Molecular Imaging	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

N/A

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 :

Feb 16, 2017

Actual Primary Completion Date :

Mar 20, 2020

Actual Study Completion Date :

Dec 17, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Imaging

Molecular Imaging

Other: Molecular Imaging

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

Outcome Measures

Primary Outcome Measures

Functional imaging metabolic response contrasted with conventional imaging response [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

Functional imaging response [10 weeks]
The percent change in the SUVmax of the most intensely FDG/DCFPyL avid lesion relative to Baseline.
Radiological progression free survival. [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
Prostate specific antigen (PSA) response [3 years]
The time from registration to the date of PSA progression
Progressive Disease (example change in treatment, skeletal related event) [3 years]
The time from registration to initiation of anti-cancer intervention or death from any cause.
Overall Survival [3 years]
The time from registration to the date of death from any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Juravinski Hospital and Cancer Centre	Hamilton	Ontario	Canada
2	London Health Sciences Centre	London	Ontario	Canada
3	Sunnybrook-Odette Cancer Centre	Toronto	Ontario	Canada

Sponsors and Collaborators

Ontario Clinical Oncology Group (OCOG)

Investigators

Principal Investigator: Katherine Zukotynski, Hamilton Health Sciences Corporation
Principal Investigator: Eric Winquist, London Health Sciences Centre