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68Ga-PSMA PET/CT Scan for Prostate Cancer
Phase 3
Waitlist Available
Led By Rajan Rakheja
Research Sponsored by University of Saskatchewan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status 0 - 3, inclusive
Previously diagnosed with prostate cancer, under referring physician's care
Must not have
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 who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial involves giving prostate cancer patients a special radioactive substance to take detailed images of their cancer. The goal is to improve how doctors detect and monitor prostate cancer. The substance helps highlight cancer cells, making them easier to see on the scan.
Who is the study for?
This trial is for men over 18 with prostate cancer, who can lie still for up to 40 minutes and handle an IV injection. They should be under a doctor's care with an ECOG status of 0-3, meaning they have varying levels of ability to perform daily activities. Those unstable in health, too heavy or large for the PET/CT equipment, or severely claustrophobic cannot join.
What is being tested?
The trial tests how well a special type of imaging called 68Ga-PSMA PET/CT works in detecting prostate cancer spread compared to standard scans. It involves one additional scan using a radioactive tracer and follows patients immediately after and two weeks later for any side effects.
What are the potential side effects?
Possible immediate side effects include reactions at the injection site or allergic responses to the tracer used in the scan. Delayed side effects are checked by phone after one to two weeks but are generally minimal as this is primarily an imaging technique.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself but may not be fully active.
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I have been diagnosed with prostate cancer and am under a doctor's care.
Select...
I am 18 years old or older.
Select...
I can lie still for 40 minutes and handle an IV injection for a PET/CT scan.
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I am male.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I weigh less than 400 lbs and can fit into a PET/CT scanner.
Select...
I am not currently experiencing any severe health crises like heart or breathing problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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.
Secondary study objectives
The secondary endpoint is the number of adverse events, both immediate and delayed.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Group I: High Risk Prostate CancerExperimental Treatment1 Intervention
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.
Group II: Biochemical ReoccurrenceExperimental Treatment1 Intervention
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Prostate cancer treatments often target specific mechanisms to inhibit cancer growth and spread. One such mechanism involves targeting the prostate-specific membrane antigen (PSMA), a protein highly expressed on prostate cancer cells.
Treatments like 68Ga-PSMA-11 bind to PSMA, allowing for improved imaging in PET/CT scans, which helps in accurately detecting and staging the cancer. This precision is crucial for tailoring treatment plans.
Other common treatments include androgen deprivation therapy (ADT), which reduces levels of male hormones that can fuel cancer growth, and chemotherapy, which kills rapidly dividing cancer cells. Understanding these mechanisms helps patients and doctors choose the most effective treatment strategy based on the cancer's specific characteristics.
Effect of <sup>18</sup>F-DCFPyL PET/CT on the Management of Patients with Recurrent Prostate Cancer: Results of a Prospective Multicenter Registry Trial.Considerations on Integrating Prostate-Specific Membrane Antigen Positron Emission Tomography Imaging Into Clinical Prostate Cancer Trials by National Clinical Trials Network Cooperative Groups.Choosing the right treatment for patients with psoriatic arthritis.
Effect of <sup>18</sup>F-DCFPyL PET/CT on the Management of Patients with Recurrent Prostate Cancer: Results of a Prospective Multicenter Registry Trial.Considerations on Integrating Prostate-Specific Membrane Antigen Positron Emission Tomography Imaging Into Clinical Prostate Cancer Trials by National Clinical Trials Network Cooperative Groups.Choosing the right treatment for patients with psoriatic arthritis.
Find a Location
Who is running the clinical trial?
University of SaskatchewanLead Sponsor
256 Previous Clinical Trials
154,877 Total Patients Enrolled
Rajan RakhejaPrincipal InvestigatorUniversity of Saskatchewan
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can care for myself but may not be fully active.I have been diagnosed with prostate cancer and am under a doctor's care.I am 18 years old or older.I weigh less than 400 lbs and can fit into a PET/CT scanner.I am not currently experiencing any severe health crises like heart or breathing problems.I can lie still for 40 minutes and handle an IV injection for a PET/CT scan.You cannot participate if you have severe claustrophobia that cannot be managed.I am male.
Research Study Groups:
This trial has the following groups:- Group 1: High Risk Prostate Cancer
- Group 2: Biochemical Reoccurrence
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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