68Ga-PSMA PET/CT in Prostate Cancer

NCT03001869 | Completed Phase 3

• 1 other identifier: 16-293
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are to replicate the safety and efficacy of 68Ga-PSMA PET/CT and as a diagnostic and decision making tool in the management prostate cancer patients.The primary endpoints of the study are the incidence of adverse events (AE) in the study population up to 7 days following the scan, and the sensitivity and specificity of 68Ga-PSMA PET/CT vs CT on a per-patient and per-lesion basis.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• Safety of Ga68-PSMA PET/CT imaging as measured by the incidence of adverse events (AE)

  7 days

• Efficacy of Ga68-PSMA PET/CT imaging as measured by sensitivity and specificity vs CT on a per patient basis as compared to standard of truth

  12 months

• Efficacy of Ga68-PSMA PET/CT imaging as measured by sensitivity and specificity vs CT on a per lesion basis as compared to standard of truth

  12 months

Study Arms (1)

68Ga-PSMA PET/CT

EXPERIMENTAL

68Ga-HBED-CC-PSMA PET/CT

Drug: 68Ga-HBED-CC-PSMA PET/CT

Interventions

68Ga-HBED-CC-PSMA PET/CT DRUG

68Ga-HBED-CC-PSMA PET/CT Scan

Also known as: 68Ga-PSMA-11

68Ga-PSMA PET/CT

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Resident of Canada
• 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

You may not qualify if:

• 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
• Clinical Indication Criteria Subgroups:
• BCR: Biochemical recurrence as defined by serum PSA \> 0.1 ng/ml following either radical prostatectomy or curative-intent radiotherapy or other prostate-ablative definitive management
• HRS: Staging of high risk patients as defined by any one of the following:
• Gleason score \> 7
• Serum PSA \> 10 ng/ml
• T stage of T3 or greater on TNM staging
• Equivocal conventional staging such as CT, MRI or bone scan
• Clinical suspicion of advance stage disease (e.g. bone pain)

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Nuclear Medicine

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: December 23, 2016
• Study Start: July 1, 2017
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: November 27, 2023

Record last verified: 2023-11

Locations

CA (1)