Assessment of New Molecular Imaging Strategies for Prostate Cancer

Ontario Clinical Oncology Group (OCOG)36 enrolled

Overview

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.

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

Molecular ImagingOTHER

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Juravinski Hospital and Cancer Centre

Hamilton, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

Sunnybrook-Odette Cancer Centre

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: 10 weeks

Secondary Outcomes

Functional imaging response

The percent change in the SUVmax of the most intensely FDG/DCFPyL avid lesion relative to Baseline.

Time frame: 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

Time frame: 3 years

Prostate specific antigen (PSA) response

The time from registration to the date of PSA progression

Time frame: 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.

Time frame: 3 years

Overall Survival

The time from registration to the date of death from any cause.

Time frame: 3 years

Data from ClinicalTrials.gov

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