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68Ga-PSMA PET/CT in Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
68Ga-PSMA PET/CT
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male sex
  • Age 18 years or older
  • Previously diagnosed with prostate cancer, under referring physician's care
  • ECOG performance status 0 - 3, inclusive
  • Able to understand and provide written informed consent
  • Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation for injection

Exclusion Criteria:

  • Patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)
  • Patients who exceed the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or who cannot fit through the PET/CT bore (usually approximately 70 cm diameter)
  • Patients with unmanageable claustrophobia

Sites / Locations

  • Royal University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Biochemical Reoccurrence

High Risk Prostate Cancer

Arm Description

Patients with biochemical reoccurrence (post-prostatectomy or post radical radiotherapy) or patients with biochemical relapse with rising PSA in spite of taking hormone treatment (this situation is characterized as non-metastatic castration resistant prostate cancer M0CRPC) and compare it to bone scan and CT in 2 groups: PSA >= 0.2 ng/mL and <= 0.5 ng/mL or PSA > 0.5 ng/ml

Patients with high risk prostate cancer who have not received any definitive treatment. These high-risk patients are defined using the D'Amico Classification System: Those with a PSA of more than 20, or a Gleason score equal to or greater than 8, or have a clinical stage greater than T2c.

Outcomes

Primary Outcome Measures

Sensitivity and specificity of 68Ga-PSMA-11 PET/CT compared to that of CT alone and bone scan in two different cohorts of prostrate cancer patients.
PET/CT images, CT-alone images and bone scans will be read by separate readers who will not be blinded to all other clinical and imaging information. A target lesion list will be created, finalized and entered into the research study file. Reviewer will assign each patient an overall likelihood of prostate cancer score, equal to the highest score of any target lesion on the PET/CT scan. Following the entry of final PET/CT, CT-only and bone scan target lesion lists and overall likelihood scores into the study file, all the experienced readers will become un-blinded and adjudicate by consensus in conjunction with referring physicians all lesions identified by each on their respective datasets and will assign a final consensus to each lesion. Each target lesion identified by each reader will be followed clinically, radiologically and histopathologically over a minimum period of 6 months and the final consensus can be modified based on this follow-up.

Secondary Outcome Measures

The secondary endpoint is the number of adverse events, both immediate and delayed.
Immediate and delayed adverse events will be captured for every patient and will be analysed at the end of study.

Full Information

First Posted
December 14, 2020
Last Updated
December 22, 2020
Sponsor
University of Saskatchewan
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1. Study Identification

Unique Protocol Identification Number
NCT04684628
Brief Title
68Ga-PSMA PET/CT in Prostate Cancer
Official Title
Investigation of the Sensitivity and Specificity of 68Ga-HBED-CC-PSMA PET/CT in Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2020 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a single-center, multi-arm, open-label, phase III trial in up to 500 patients with biopsy-proven prostate cancer. Participants will receive regular standard of clinical care. The only study-specific procedures will the administration of 68Ga-PSMA-11 followed by a PET/CT (positron emission tomography/computed tomography) scan. Participants will be followed for two hours after the infusion for identification of any immediate adverse events (AE), and will be contacted by telephone after 7 to 14 days to enquire about any delayed AEs. PET/CT images, CT-alone images and bone scans will be read by separate readers who will not be blinded to all other clinical and imaging information. The standard of truth will be a consensus of the readers based on all available clinical, imaging, and histopathological information available for up to 6 months after the PET/CT scan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
There will be two groups depending upon the disease status. Cohort 1- Participant will be in Cohort 1 if have biochemical reoccurrence (post-prostatectomy or post radical radiotherapy) or have biochemical relapse with rising PSA in spite of taking hormone treatment (this situation is characterized as non-metastatic castration resistant prostate cancer M0CRPC). Cohort 2- Participant will be in Cohort 2 if have high risk prostate cancer and have not received any definitive treatment. Participants of both cohorts will receive the same study drug for imaging procedure. Participants of both the cohort will undergo one PET/CT scan at 45 minute after a single dose injection of 68Ga-PSMA-11.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biochemical Reoccurrence
Arm Type
Experimental
Arm Description
Patients with biochemical reoccurrence (post-prostatectomy or post radical radiotherapy) or patients with biochemical relapse with rising PSA in spite of taking hormone treatment (this situation is characterized as non-metastatic castration resistant prostate cancer M0CRPC) and compare it to bone scan and CT in 2 groups: PSA >= 0.2 ng/mL and <= 0.5 ng/mL or PSA > 0.5 ng/ml
Arm Title
High Risk Prostate Cancer
Arm Type
Experimental
Arm Description
Patients with high risk prostate cancer who have not received any definitive treatment. These high-risk patients are defined using the D'Amico Classification System: Those with a PSA of more than 20, or a Gleason score equal to or greater than 8, or have a clinical stage greater than T2c.
Intervention Type
Drug
Intervention Name(s)
68Ga-PSMA PET/CT
Intervention Description
Administration of 68Ga-PSMA-11 followed by a PET/CT scan at 45 min after injection.
Primary Outcome Measure Information:
Title
Sensitivity and specificity of 68Ga-PSMA-11 PET/CT compared to that of CT alone and bone scan in two different cohorts of prostrate cancer patients.
Description
PET/CT images, CT-alone images and bone scans will be read by separate readers who will not be blinded to all other clinical and imaging information. A target lesion list will be created, finalized and entered into the research study file. Reviewer will assign each patient an overall likelihood of prostate cancer score, equal to the highest score of any target lesion on the PET/CT scan. Following the entry of final PET/CT, CT-only and bone scan target lesion lists and overall likelihood scores into the study file, all the experienced readers will become un-blinded and adjudicate by consensus in conjunction with referring physicians all lesions identified by each on their respective datasets and will assign a final consensus to each lesion. Each target lesion identified by each reader will be followed clinically, radiologically and histopathologically over a minimum period of 6 months and the final consensus can be modified based on this follow-up.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The secondary endpoint is the number of adverse events, both immediate and delayed.
Description
Immediate and delayed adverse events will be captured for every patient and will be analysed at the end of study.
Time Frame
baseline (i.e. Imaging visit) and at the end of study visit (day 7 to day 14)

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Adult male participant previously diagnosed with prostate cancer, under referring physician's care.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male sex Age 18 years or older Previously diagnosed with prostate cancer, under referring physician's care ECOG performance status 0 - 3, inclusive Able to understand and provide written informed consent Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation for injection Exclusion Criteria: Patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive) Patients who exceed the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or who cannot fit through the PET/CT bore (usually approximately 70 cm diameter) Patients with unmanageable claustrophobia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Supriya Arora
Phone
306-655-3351
Email
supriya.arora@usask.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Humphrey Fonge
Phone
306-655-3353
Email
humphrey.fonge@usask.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajan Rakheja
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Co-Investigator
Phone
306-655-3353
Email
humphrey.fonge@usask.ca
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
306-655-3351
Email
supriya.arora@usask.ca
First Name & Middle Initial & Last Name & Degree
Rajan Rakheja

12. IPD Sharing Statement

Learn more about this trial

68Ga-PSMA PET/CT in Prostate Cancer

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