Assessment of New Molecular Imaging Strategies for Prostate Cancer

Prostate Cancer Clinical Trial

— MISTER  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02813226
• Other study ID #: OCOG-2016-MISTER
• Status: Completed
• Phase: N/A
• Start date: February 16, 2017
• Est. completion date: December 17, 2021

Study information

• Verified date: December 2021
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 17, 2021
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Molecular Imaging
Baseline and follow-up FDG PET-CT and DCFPyL PET-CT

Locations

Country	Name	City	State
Canada	Juravinski Hospital and Cancer Centre	Hamilton	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Sunnybrook-Odette Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Functional imaging response	The percent change in the SUVmax of the most intensely FDG/DCFPyL avid lesion relative to Baseline.	10 weeks
Secondary	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
Secondary	Prostate specific antigen (PSA) response	The time from registration to the date of PSA progression	3 years
Secondary	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
Secondary	Overall Survival	The time from registration to the date of death from any cause.	3 years