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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Molecular Imaging

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada
      • Juravinski Hospital and Cancer Centre
    • London, Ontario, Canada
      • London Health Sciences Centre
    • Toronto, Ontario, Canada
      • Sunnybrook-Odette Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ontario Clinical Oncology Group (OCOG)
• Investigators: Principal Investigator: Katherine Zukotynski, Hamilton Health Sciences Corporation; Principal Investigator: Eric Winquist, London Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2017
• Primary Completion (Actual): March 20, 2020
• Study Completion (Actual): December 17, 2021

Study Registration Dates

• First Submitted: June 22, 2016
• First Submitted That Met QC Criteria: June 22, 2016
• First Posted (Estimate): June 24, 2016

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: enzalutamide; molecular imaging; metabolic response; abiraterone acetate; castration-resistant
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: OCOG-2016-MISTER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No