Assessment of New Molecular Imaging Strategies for Prostate Cancer

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Other: Molecular Imaging

• Registration Number: NCT02813226
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-24
• Study Start: 2017-02-16
• Primary Completion: 2020-03-20
• Status Verified: 2021-12
• Study Completion: 2021-12-17
• Last Update Submitted: 2021-12-20
• Last Update Posted: 2021-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imaging	Molecular Imaging	Molecular Imaging

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Functional imaging response	10 weeks	The percent change in the SUVmax of the most intensely FDG/DCFPyL avid lesion relative to Baseline.
Overall Survival	3 years	The time from registration to the date of death from any cause.

Trial Locations

Locations (3)

Juravinski Hospital and Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Sunnybrook-Odette Cancer Centre; 🇨🇦 Toronto, Ontario, Canada