What side effects are associated with this type of intervention?

The 68Ga-PSMA-11 trial involves PET/CT imaging to improve the detection of prostate cancer. Common treatments for prostate cancer include androgen deprivation therapy (ADT), radiation therapy, and chemotherapy. ADT can cause side effects such as fatigue, hot flashes, loss of libido, and osteoporosis. Radiation therapy may lead to urinary symptoms, bowel issues, and erectile dysfunction. Chemotherapy, such as with docetaxel, can result in nausea, hair loss, fatigue, and increased risk of infections. Additionally, newer treatments like lutetium Lu 177 vipivotide tetraxetan, used in PSMA-targeted radioligand therapy, can cause myelosuppression, nephrotoxicity, and salivary gland toxicity.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, particularly for metastatic castration-resistant prostate cancer (CRPC). One notable approval is for lutetium Lu 177 vipivotide tetraxetan, a radioligand therapy targeting PSMA, which has shown significant efficacy in improving progression-free survival and overall survival in patients with PSMA-positive metastatic CRPC. Additionally, radium-223 (Ra-223) has been approved for targeting bone metastases in CRPC, demonstrating benefits in survival and symptom management. These treatments, along with the investigational use of 68Ga-PSMA-11 for improved imaging in PET/CT scans, highlight the advancements in targeting PSMA for both diagnostic and therapeutic purposes in prostate cancer.

What other types of research exist?

Promising alternatives to 68Ga-PSMA-11 for prostate cancer imaging include [44Sc]Sc-PSMA-617 and 64Cu-PSMA-ALB-89. [44Sc]Sc-PSMA-617 has shown potential in PET imaging of metastasized castrate-resistant prostate cancer, while 64Cu-PSMA-ALB-89 has demonstrated favorable in vivo stability and tissue distribution profiles in preclinical evaluations.

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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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I weigh less than 400 lbs and can fit into a PET/CT scanner.

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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

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

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

0 / 7Eligibility criteria met

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 18F-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.