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68Ga-PSMA PET/CT Scan for Prostate Cancer

Phase 3

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is testing a new way to look for prostate cancer using a PET/CT scan. The study is open label, which means that participants and doctors will know which treatment is being given. The study will follow participants for up to 6 months to see how well the PET/CT scan works.

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.Check my eligibility

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.See study design

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 below

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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.

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I am 18 years old or older.

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I can lie still for 40 minutes and handle an IV injection for a PET/CT scan.

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I am male.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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.

Secondary outcome measures

The secondary endpoint is the number of adverse events, both immediate and delayed.

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of SaskatchewanLead Sponsor

251 Previous Clinical Trials

153,910 Total Patients Enrolled

Rajan RakhejaPrincipal InvestigatorUniversity of Saskatchewan

Media Library

68Ga-PSMA PET/CT Clinical Trial Eligibility Overview. Trial Name: NCT04684628 — Phase 3

Prostate Cancer Research Study Groups: High Risk Prostate Cancer, Biochemical Reoccurrence

Prostate Cancer Clinical Trial 2023: 68Ga-PSMA PET/CT Highlights & Side Effects. Trial Name: NCT04684628 — Phase 3

68Ga-PSMA PET/CT 2023 Treatment Timeline for Medical Study. Trial Name: NCT04684628 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open positions in this clinical trial for new patients?

"This clinical trial is actively recruiting patients, according to the latest information on clinicaltrials.gov. The listing for this study was first posted on December 9th 2020 and updated on December 22nd of the same year."

Answered by AI

Does this research allow for volunteers who are still in their twenties?

"Eligibility requirements for this clinical trial state that patients must be aged 18 to 100. Out of the 80 trials available for minors, and 1358 trials available for senior citizens, this is the only one that includes them both."

Answered by AI

For whom is this trial looking for participants?

"Eligibility requirements for this prostate cancer trial include being between 18 and 100 years old. So far, 500 people have signed up to participate in the study."

Answered by AI

What risks are associated with 68Ga-PSMA PET/CT?

"There is available clinical data that suggests 68Ga-PSMA PET/CT is safe, giving it a score of 3."

Answered by AI

How many test subjects are a part of this clinical research?

"That is correct. The clinical trial was originally posted on 12/9/2020 and was most recently edited on 12/22/2020. The study is looking for 500 patients at 1 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

68Ga-PSMA PET/CT in Prostate Cancer

Rajan Rakheja 2020. "68Ga-PSMA PET/CT in Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04684628.

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