Assessment of New Molecular Imaging Strategies for Prosta... | NCT02813226

Studies
Assessment of New Molecular Imaging Strategies for Prostate Cancer

NCT02813226

Sponsor

Ontario Clinical Oncology Group (OCOG)

Status

Completed

Last Update Posted

Dec 21, 2021Actual

Enrollment

36Actual

Phase

Not Applicable

Conditions

Prostate Cancer

Interventions

Molecular Imaging

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 16, 2017Actual

Primary Completion Date

Mar 20, 2020Actual

Completion Date

Dec 17, 2021Actual

First Submitted Date

Jun 22, 2016

First Submission Date that Met QC Criteria

Jun 22, 2016

First Posted Date

Jun 24, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2021

Last Update Posted Date

Dec 21, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Label	Type	Description	Intervention Names
Imaging	Other	Molecular Imaging	Other: Molecular Imaging

Name	Type	Description	Arm Group Labels	Other Names
Molecular Imaging	Other	Baseline and follow-up FDG PET-CT and DCFPyL PET-CT	Imaging

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Katherine Zukotynski	Hamilton Health Sciences Corporation	Principal Investigator
Eric Winquist	London Health Sciences Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Juravinski Hospital and Cancer Centre		Hamilton	Ontario		Canada
London Health Sciences Centre

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D015336	Molecular Probe Techniques