68Ga-PSMA PET/CT in Prostate Cancer

University of Saskatchewan

Status and phase: Suspended; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: 68Ga-PSMA PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT04684628

PSMA-01

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: Male

Ages: 18 to 100 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Biochemical Reoccurrence

Experimental group

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

Treatment:

Drug: 68Ga-PSMA PET/CT

High Risk Prostate Cancer

Experimental group

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.

Treatment:

Drug: 68Ga-PSMA PET/CT