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68Ga-PSMA PET/CT in Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04684628
Recruitment Status : Recruiting
First Posted : December 24, 2020
Last Update Posted : December 24, 2020
Sponsor:
Information provided by (Responsible Party):
Rajan Rakheja, University of Saskatchewan

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 68Ga-PSMA PET/CT Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Investigation of the Sensitivity and Specificity of 68Ga-HBED-CC-PSMA PET/CT in Prostate Cancer
Actual Study Start Date : December 9, 2020
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Biochemical Reoccurrence

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

Drug: 68Ga-PSMA PET/CT
Administration of 68Ga-PSMA-11 followed by a PET/CT scan at 45 min after injection.

Experimental: High Risk Prostate Cancer
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.
Drug: 68Ga-PSMA PET/CT
Administration of 68Ga-PSMA-11 followed by a PET/CT scan at 45 min after injection.




Primary Outcome Measures :
  1. 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. [ Time Frame: 6 months ]
    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 :
  1. The secondary endpoint is the number of adverse events, both immediate and delayed. [ Time Frame: baseline (i.e. Imaging visit) and at the end of study visit (day 7 to day 14) ]
    Immediate and delayed adverse events will be captured for every patient and will be analysed at the end of study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Adult male participant previously diagnosed with prostate cancer, under referring physician's care.
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04684628


Contacts
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Contact: Supriya Arora 306-655-3351 supriya.arora@usask.ca
Contact: Humphrey Fonge 306-655-3353 humphrey.fonge@usask.ca

Locations
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Canada, Saskatchewan
Royal University Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Co-Investigator    306-655-3353    humphrey.fonge@usask.ca   
Contact: Study Coordinator    306-655-3351    supriya.arora@usask.ca   
Principal Investigator: Rajan Rakheja         
Sponsors and Collaborators
University of Saskatchewan
Investigators
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Principal Investigator: Rajan Rakheja University of Saskatchewan
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Responsible Party: Rajan Rakheja, Assistant Professor, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT04684628    
Other Study ID Numbers: PSMA-01
First Posted: December 24, 2020    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Gallium 68 PSMA-11
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action